Επαγγέλματα Υγείας

LastWeek

LastThreeDays

Today

Aoristou

FullTime

OnSite

The RIO Execution Hub Manager is responsible for providing regulatory support to the International country and/or cluster Regulatory teams.The Hub Managers work across portfolio phases from initial applications, commercial lifecycle through to product withdrawal. They support numerous regulatory activities that include but are not limited to:<ul><li>M1 dossier components (local document authoring and/or coordination</li><li>Simple local only HA query responses</li><li>Provide support for general x-functional support to country Regulatory teams for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning</li></ul>This role acts as initial point of contact for assigned Country/Cluster under his/her responsibility for Country Regulatory Strategist, Hub Submission manager/Dossier Manager, and other key stakeholders involved in the processes described above.It is expected that this role partners closely with the Country Regulatory Strategist and Hub Submission/Dossier Managers to enable timely, high-quality submissions and sustained compliance. This includes but is not limited to:<ul><li>Identification of regulatory requirements (for the in-scope submission categories defined)</li><li>Authoring, delivery and/or coordination of local, submission-ready documents</li><li>The quality review/approval of the Dossier provided by Hub Submission/Dossier Managers (for the in-scope submission categories defined)</li></ul>JOB RESPONSIBILITIESRIO Execution Hub manager is focused on end-to-end management of multi-regional, regional and national regulatory dossiers for assigned cluster/country/therapeutic area/products, both initial registration applications and ongoing lifecycle management through to product withdrawal. Associated functions are engaged to provide smooth operational performance and process efficiency.This role executes the GRS mission by delivering against goals, executing initiatives, implementing new opportunities, and filling gaps related to the production of regulatory International and operational support. A key component of this role is the implementation of portfolio execution efficiencies, identification and escalation of quality and compliance issues or emerging risks detected during the management of the Cluster/Country portfolio under his/her responsibility.&nbsp;Success in this role is measured by the timeliness, quality, compliance, and efficient delivery of critical on-the-job deliverables, bringing efficiencies to the organization.In some regions/clusters, the RIO Execution Hub manager can execute the role of Hub Submission Manager, while in others should closely partner with Hub Submission Manager.KEY ACCOUNTABILITIESGeneral accountabilities (For reference only):<ul><li>Ensure timely delivery of local M1 dossier components</li><li>Act as the initial point of contact for assigned cluster/country under his/her responsibility for RIO Execution Hub Team Lead and key stakeholders, including the Country Regulatory Strategist and Hub Submission manager, for the processes under his/her responsibility</li><li>Provide Regulatory support for x-functional support assigned to him/her to local affiliates for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning</li><li>Provide support for local audit readiness activities including audit interviews as needed, Dear Healthcare Professional Communication (DHPC) responses, and responses to medical info requests as required</li><li>Support country regulatory strategists with country x-functional meetings e.g., on launch plans, as required</li><li>Perform Quality review/approval of the Dossier build Table of Contents provided by Hub Submission/Dossier Managers (for the in-scope submissions under his/her responsibility)</li><li>Partner with Grow submission managers and Regional Submission Hubs to deliver<ul><li>Growth applications to meet International Commercial knots prioritisation and Op plans</li></ul></li><li>Support RIO and International Regional Leadership partnering with Submission Hubs for<ul><li>International Commercial knot prioritisation discussions for Op plan cycle</li><li>GRS lifecycle prioritisation discussions for CMC and Labelling changes</li></ul></li></ul>Local document authoring &amp; submission prep (For reference only)<ul><li>Author and review of M1 local documents (cover letters, variations, MA applications), and relevant translations</li><li>May engage with Labeling Hubs and clusters/countries on Labels and Artwork updates to include local requirements, ensuring alignment with approved text and supporting launch activities</li><li>Support clusters/countries with authoring of simple HA query responses e.g., admin related requests, and coordinate with relevant SMEs/functions (e.g., CMC) to address more complex HA queries, based on CRS query response strategy</li></ul>ManagerBusiness Experiences:<ul><li>Provides regulatory support to simple and complex regulatory activities in the assigned country/cluster (e.g., Initial applications, commercial lifecycle through to product withdrawal, tenders, audits, launch planning) and applies technical experience to impact business results</li><li>Lead regulatory support to countries/clusters with challenging internal and external constraints</li><li>Acts as a regulatory matter expert with extensive regulatory expertise working across different clusters and/or regions to consolidate Regulatory activity, with close matrix collaboration with strategists and other local and above country cross-functional stakeholders</li></ul>Non-Portfolio Experiences:<ul><li>Represents the RIO function and plays key roles in RIO, GI&amp;PE and GRS improvement projects</li></ul>Senior ManagerBusiness Experiences:<ul><li>Leadership of complex regulatory activities to support different clusters, regions (e.g., major submissions or national portfolios, tenders, audits, launching plans) and application of domain experience to influence business results</li><li>Involvement in visible and timebound complex and/or high volume projects with pan regional impact with challenging constraints</li></ul>Non-Portfolio Experiences:<ul><li>Leads continuous improvement projects that impact people, technology, and/or processes within RIO Hubs, and/or represent RIO playing key leadership roles in transformation projects in broader GI&amp;PE and GRS</li></ul>QUALIFICATIONS / SKILLS<ul><li>B.S./B.Scs. is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered</li><li>Advanced to Fluent English language required. Multilingual skills desirable</li><li>Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards</li><li>Advanced Microsoft Office Suite skills</li><li>Familiarity with pharmaceutical organizational structures, systems, and culture</li><li>An understanding of country/cluster regulatory requirements and trends is preferred</li><li>Relevant experience within pharma, in Regulatory, quality and/or compliance fields</li></ul>Working habits (qualitative examples):Manager<ul><li>A colleague who does not require management oversight on daily work, self-initiates problem solving and is able to navigate ambiguous situations impacting GRS and beyond through to results. Recognizes when escalation/status updates are required</li><li>Demonstrates domain expertise which drives execution in complex submission strategies and impacts outcomes on business results</li><li>Demonstrated experience in matrix management where the colleague does not have autonomy</li><li>Pre-empts internal / external risk to organization and raises/ partners to mitigate</li></ul>Senior Manager<ul><li>A colleague who does not require management oversight on daily work, self-initiates problem solving and is able to navigate ambiguous situations impacting RIO, GI&amp;PE and/or GRS and beyond through to results. Recognizes when escalation is required.</li><li>Demonstrates domain expertise which drives execution in complex submission strategies and impacts outcomes on business results</li><li>Demonstrated experience in matrix management where the colleague does not have autonomy</li><li>Pre-empts internal / external risk to organization and raises/ partners to mitigate</li></ul>ORGANIZATIONAL RELATIONSHIPSRIO Execution Hub ManagerInteracts with:<ul><li>Country/Cluster teams, Submission Manager hubs and other functions across RIO</li><li>GIPE, GRS broader organization RIO Execution Hub Manager can interact with Local affiliate cross functional teams for BAU well defined M1 local components (e.g. Medical, Safety, Clinical, DRSD). informing or via the Country Regulatory team per agreements established</li></ul>RESOURCES MANAGED<ul><li>Project specific resources</li></ul>

RIO Execution Hub Manager (Manager / Sr. Manager)

The RIO Execution Hub Associate/Sr Associate is responsible for providing regulatory support to the International country and/or cluster Regulatory teams.The Execution Hub Associates/Sr Associates work across portfolio phases from initial registration applications, lifecycle management through to product withdrawal. They support numerous regulatory activities that include but are not limited to:<ul><li>M1 dossier components (local document authoring and/or coordination)</li><li>Simple local only HA query responses</li><li>Provide support for general x-functional activities to country Regulatory teams for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning</li></ul>It is expected that this role partners closely with the Country Regulatory Strategist and Hub Submission/Dossier Managers to enable timely, high-quality submissions and sustained compliance. This includes but is not limited to:<ul><li>Identification of regulatory requirements (for the in-scope submission categories defined),</li><li>Authoring, delivery and/or coordination of local, submission-ready documents</li><li>The quality review/approval of the Dossier provided by Hub Submission/Dossier Managers (for the in-scope submission categories defined)</li></ul>JOB RESPONSIBILITIESRIO Execution Hub Associate/ /Sr Associate is focused on end-to-end management of multi-regional, regional and national regulatory dossiers for assigned cluster/country/therapeutic area/products, both initial registration applications and ongoing lifecycle management through to product withdrawal. Associated functions are engaged to provide smooth operational performance and process efficiency.This role executes the GRS mission by delivering against goals, executing initiatives, implementing new opportunities, and filling gaps related to the production of regulatory International and operational support. A key component of this role is the implementation of portfolio execution efficiencies, identification and escalation of quality and compliance issues or emerging risks detected during the management of the Cluster/Country submissions under his/her responsibility.&nbsp;Success in this role is measured by the timeliness, quality, compliance, and efficient delivery of critical on-the-job deliverables, bringing efficiencies to the organization.In some regions/clusters, the RIO Execution Hub can execute the role of Hub Submission Manager, while in others should closely partner with Hub Submission Manager.KEY ACCOUNTABILITIESGeneral accountabilities (For reference only):<ul><li>Ensure timely delivery of local M1 dossier components</li><li>Perform Quality review/approval of the Dossier build Table of Contents provided by Hub Submission/Dossier Managers (for the in-scope submissions under his/her responsibility)</li><li>Can provide support for simple tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and regulatory information status for launch planning</li><li>Provide support for local audit readiness activities, Dear Healthcare Professional Communication (DHPC) responses, and responses to medical info requests as requested</li><li>Parther with Grow submission managers and Regional Submission Hubs to meet growth application delivery in line with International Commercial knots prioritisation and OP plans</li><li>Partner with Submission Hubs to meet GRS lifecycle prioritisation for CMC and Labelling changes</li><li>Local document authoring &amp; submission prep (For reference only)</li><li>Author and review of M1 local documents (cover letters, variations, MA applications), and relevant translations</li><li>May engage with Labeling Hubs and&nbsp; clusters/countries on Labels and Artwork updates to include local requirements, ensuring alignment with approved text and supporting launch activities</li><li>Support clusters/countries with authoring of simple HA query responses e.g., admin related requests, and coordinate with relevant SMEs/functions (e.g., CMC) to address more complex HA queries, based on CRS query response strategy</li></ul>Portfolio – Non Portfolio Support (qualitative examples):AssociateBusiness Experiences:<ul><li>Provides regulatory support to lower complexity regulatory activities in the assigned country/Cluster (mainly&nbsp; for commercial lifecycle through to product withdrawal) and applies technical experience to impact business results</li></ul>Non-Portfolio Experiences:<ul><li>Provides input to projects requested within RIO Hubs</li></ul>Senior AssociateBusiness Experiences:<ul><li>Provides regulatory support to lower to medium complexity regulatory activities in the assigned country (Initial applications, commercial lifecycle through to product withdrawal, simple tenders, audits, launch planning support) and applies technical experience to impact business results</li></ul>Non-Portfolio Experiences:<ul><li>Provides subject matter expert (SME) input to projects that impact people, technology, and/or processes within RIO Hubs, GI&amp;PE and GRS</li></ul>QUALIFICATIONS / SKILLS<ul><li>B.S./B.Scs. is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered</li><li>Advanced to Fluent English language required. Multilingual skills desirable</li><li>Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards</li><li>Advanced Microsoft Office Suite skills</li><li>Familiarity with pharmaceutical organizational structures, systems, and culture is preferred.</li><li>An understanding of country/cluster regulatory requirements and trends is preferred</li><li>Relevant experience within pharma, in Regulatory, quality and/or compliance fields preferred</li></ul>Working habits (qualitative examples)Associate<ul><li>Colleague who requires management oversight on daily work and support in problem solving</li><li>Demonstrates technical expertise which aids in task-based execution</li></ul>Senior Associate<ul><li>Self-initiates problem solving and is able to navigate ambiguous situations impacting RIO through to results. Recognizes when escalation is required</li><li>Demonstrates technical expertise which aids submission execution</li></ul>ORGANIZATIONAL RELATIONSHIPSRIO Execution Hub Associate/Sr Associate interacts with<ul><li>Country/Cluster teams, Submission Manager hubs and other functions across RIO</li><li>GIPE</li><li>RIO Execution Hub Associate/Sr Associate can interact with Local affiliate cross functional teams for BAU well defined and simple M1 local components (e.g. Medical, Safety, Clinical, DRSD). informing or via the Country Regulatory team per agreements established</li></ul>RESOURCES MANAGED<ul><li>Project specific resources</li></ul>

RIO Execution Hub Associate / Sr. Associate

The Associate Medical Director perform the medical assessment activities related to drug safety pharmacovigilance for the assigned therapeutic area(s). The Associate Medical Director proactively evaluates safety information from individual cases and cumulative data, identifies and analyses potential signals, and communicates data-driven conclusions to internal and external stakeholders.The Associate Medical Director Reports to Therapeutic Area Head or to Medical Director.What You Will AchieveIn this role, you will:<ul><li>Perform single case medical assessment, including the determination of seriousness, expectedness/listedness/labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing/coding</li><li>conventions.</li><li>Maintain the timely submission of expedited reports.</li><li>Support the achievement of the Therapeutic Area’s case processing performance timelines. Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk assessment, initiate the unblinding process (as appropriate), and make the report available for distribution.</li><li>Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems. Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.</li><li>Partner with Safety Surveillance and Risk Management and with other Worldwide Safety and Regulatory functional groups to monitor the safety profile of assigned products.</li><li>Actively participate in Risk Management Committees and other risk management activities for assigned therapeutic areas. Perform product safety reviews as appropriate.</li><li>Provide medical safety input as appropriate to Clinical Development Teams regarding expectedness/listedness/labeledness, causality, and data reconciliation.</li><li>As appropriate, provide medical safety input, and review or draft sections of response documents to health authority inquiries.</li><li>Work with the Therapeutic Area Head and Medical Review Head to proactively and effectively communicate product safety issues and proposed solutions to PSSR management and to the Office of the EU Qualified Person.</li><li>Provide timely review of and input to documents, including labeling, protocols, Investigator Brochure, and licensing agreements.</li><li>Provide timely input into product related milestones.</li><li>Provide medical input, review and analysis of Periodic Safety Update Reports, Expert Statements, Risk Management Plans, and other aggregate reports; where appropriate, draft components of these reports. Ensure accurate, relevant, and meaningful ICSR data and insights.</li><li>Provide medical advice and insights to Therapeutic Area colleagues to improve the quality, consistency, accuracy, and clinical relevance of safety reports.</li><li>Support PSSR Quality Assurance activities, addressing observations related to medical assessment, as appropriate. Ensure consistency and quality of the medical assessment process.</li><li>Provide drug safety support when appropriate to product acquisitions, recalls, and legal issues.</li><li>Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed.</li><li>Proactively communicate with and engage Therapeutic Area colleagues and key stakeholders (e.g., Clinical Development Teams, Regulatory Affairs, Licensing, Manufacturing, and Marketing) to support business objectives and to discuss and resolve safety issues.</li><li>Engage internal and external customers with a sense of urgency and an appreciation of their needs and point of view.</li><li>As an individual contributor, initiate and/or take a leadership role in projects/process improvements that align with PSSR strategic objectives.</li><li>Develop and maintain comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology) for the assigned product portfolio.</li><li>Develop and maintain a comprehensive working knowledge of current regulations governing the processing and reporting of safety data, Standard Operating Procedures, Safety Job Aids, and case processing/coding conventions, consistently completing curriculum training by the specified due dates.</li><li>Utilize the corporate performance management process to manage goal setting and individual development. Consistently demonstrate Pfizer Values and Leader Behaviors.</li><li>Proactively mentor Therapeutic Area colleagues to foster an environment of trust, understanding, learning, and development.</li><li>Manage or contribute to the mentoring and on-boarding of new PSSR colleagues</li></ul>Here Is What You Need Technical Skill Requirements<ul><li>Demonstrated computer literacy, with proficiency in the use and management of safety databases, including the Pfizer Global Safety Database, Argus Safety, and MS Window, Excel, Word and Outlook</li><li>Ability to achieve personal objectives while meeting departmental standards of performance</li><li>Fluency in oral and written English; knowledge of additional language(s) an advantage</li><li>Experience and skill with medical writing an advantage</li></ul>Qualifications <ul><li>Medical Degree from an accredited institution</li><li>One to two years of experience as an MD in clinical practice</li><li>One to two years of relevant experience in pharmacovigilance, clinical research or related field</li><li>Pharmaceutical industry experience preferred</li><li>Working knowledge of international regulations and guidance documents as related to worldwide reporting requirements, preparation of clinical trial safety assessments, and regulatory submissions including the preparation of aggregate reports</li></ul>Please apply by sending your CV and a motivational letter in English

Θέσεις Εργασίας Ελλάδα, Pfizer-hellas, Επαγγέλματα Υγείας

rio execution hub manager (manager / sr. manager)

Pfizer Hellas

rio execution hub associate / sr. associate

Pfizer Hellas

associate medical director

Pfizer Hellas