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Orismenou

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Position Purpose<ul><li>Performs proactive safety surveillance and risk management to effect product safety signal detection &amp; evaluation, risk assessment and safety risk minimization</li><li>Works with other Pfizer functions engaged in benefit-risk management (Regulatory Affairs, Quality, CMO, Corporate Audit, etc) to enable one medical voice</li><li>Articulates clear and informed medical judgement to enable sound business decisions and to enable productive engagement with health authorities.</li></ul>Primary Responsibilities<ul><li>Act as a point of contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing WWS position(s) on safety</li><li>Chairs RMCs and Core Working Groups for his/her assigned products with oversight</li><li>Represents Pfizer WWS at internal (e.g. governance and business unit disease area leadership teams) and external forums&nbsp; (e.g. regulatory authority and business partner interactions) as agreed with Manager</li><li>Evaluates safety data of any source with oversight, identifies and analyzes safety signals, and presents medical evaluation of safety signals and benefit-risk assessments to the appropriate forums</li><li>Provides disease area specific pharmacovigilance expertise, and applies this to various business unit products assigned to him/her</li><li>Assists with preparation of basic action plans to address risk and benefit-risk issues, often requiring cross-functional activity to address safety issues and risk minimization plans</li><li>Prepares and contributes to written safety assessments and benefit-risk evaluations</li><li>Reviews and approves, as appropriate, safety documents including those pertaining to the B-R profile of Pfizer’s products</li><li>Ensures consistency of safety risk messaging for a particular product or class of products, across multiple indications/BUs. Represents SSRM on due diligence activities</li><li>Identifies opportunities for consistency and standards for safety surveillance and risk management processes</li><li>Innovates, champions and implements novel approaches to safety surveillance and risk management across Pfizer’s portfolio of products: engages in continuous improvement initiatives, Safety Sciences Research &amp; Communications activities, including methodological improvements</li><li>Engages in inspection readiness support including provision of data to project managers for metrics and activity tracking</li><li>Develops a culture of courage, excellence, equity and joy within the team including regular communications, coaching, and mentoring of the team as required.</li></ul>Technical Skill Requirements<ul><li>Medical Degree or equivalent.</li><li>Oncology background preferred not required.</li><li>Understanding of aggregate safety data and signal assessment methodology, and ability to perform benefit-risk assessments</li><li>Ability to perform safety data review, safety data assessment, Clinical safety signal identification, risk identification and risk management</li><li>Understanding of the scientific basis for therapies and drug-induced diseases</li><li>Ability to lead a cross functional team and lead through example, commitment and enthusiasm in a matrixed environment with minimal oversight</li><li>Strong scientific and medical knowledge, including fluency in the medical literature</li><li>Ability to integrate data to support benefit/risk decision-making</li><li>Understanding of statistics and analytical tools</li><li>Knowledge of global safety/regulatory issues and concerns as they relate to the business or clinical research-based compound development</li><li>Effective verbal and written communication skills.</li></ul>&nbsp;&nbsp;

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safety risk lead, sr. manager 4937297

Pfizer Hellas

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