Hybrid Safety Risk Lead, Senior Director – MD Required

at Pfizer

• Job title: Safety Risk Lead, Senior Director – MD Required
• Job type: Full Time
• Experience level: Senior
• Salary: $242,000 - $403,400 per year
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Collegeville, United States

About the role

• Senior Director Medical Safety Lead at Pfizer ensuring patient safety through proactive risk management and safety evaluations. Collaborating across departments and leading safety risk initiatives in a global context.

Responsibilities

• Acts as a Safety point of contact for the Asset Teams and chairs the Risk Management Committees (RMCs), ensuring a unified communication on safety matters for WWS
• Conducts and chairs Core Working Groups for his/her assigned products
• Represents Pfizer WWS at senior internal (e.g. governance and business unit disease area leadership teams) and external forums (e.g. regulatory authority and business partner interactions)
• Independently evaluates safety data of any source, identifies and analyzes complex safety signals, and presents medical evaluation of safety signals and benefit-risk assessments to the appropriate forums
• Provides disease-area specific pharmacovigilance expertise and applies this to various business unit products assigned to him/her.
• Prepares action plans to address risk and benefit-risk issues, often requiring cross-functional activity to address safety issues and risk minimization plans
• Reviews and approves critical safety documents regarding the B-R profile of Pfizer’s products
• Prepares and contributes to written safety assessments and benefit-risk evaluations
• Ensures consistency of safety risk messaging for a particular product or class of products, across multiple indications/BUs
• Represents SSRM on complex due diligence activities; coaches others in due diligences to support Pfizer’s business plan
• Identifies opportunities for consistency and standards for safety surveillance and risk management processes
• 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 & Communications activities, including methodological improvements
• Engages in inspection readiness support including provision of data to project managers for metrics and activity tracking
• Develops a culture of courage, excellence, equity and joy within the team including regular communications, coaching, and mentoring of colleagues as required.
• Makes decisions based on his/her clinical experience and medical expertise
• Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities.

Requirements

• MD degree with 5 years' experience to include medical (e.g. patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or drug development.
• Disease area-specific knowledge: background and experience in endocrinology, obesity, and metabolism
• Thorough understanding of safety risk management internal and external environment, including applicable regulations and guidances
• Comprehensive knowledge of drug development process and post-marketing experience, including and understanding of safety context across the drug lifecycle
• Ability to influence internal and external stakeholders
• Ability to act independently, seeking guidance as appropriate; recognizes other colleagues’ areas of expertise and engages them effectively to achieve team objectives
• Strong understanding of aggregate safety data and signal assessment methodology, and ability to perform benefit-risk assessments
• Ability to perform safety data review, safety data assessment, Clinical safety signal identification, risk identification and risk management
• Understanding of the scientific basis for therapies and drug-induced diseases
• Strong scientific and medical knowledge, including fluency in the medical literature
• Understanding of statistics and analytical tools
• Knowledge of global safety/regulatory issues and concerns as they relate to the business or clinical research-based compound development
• Effective verbal and written communication skills.
• Demonstrated leadership in day-to-day activities, including strong interpersonal and collaborative skills.
• Relevant knowledge of pharmaceutical company organizational structure, policies, and practices, as applicable to safety risk management.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Additional Pfizer Retirement Savings Contribution
• Paid vacation
• Holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage