Director, Safety Risk Lead
Pfizer
5 hours ago
Remote friendly (Pennsylvania, United States)
United States
Medical Affairs
Responsibilities:
- Oversee and perform proactive safety surveillance and risk management to detect and evaluate product safety signals, perform risk assessment, and implement safety risk minimization.
- Partner with internal functions involved in benefit-risk management (e.g., Regulatory, Quality, Clinical, Medical, Corporate Audit) to enable “one medical voice.”
- Serve as a safety point of contact for Asset Teams and chair Risk Management Committees (RMCs) to ensure unified safety communications.
- Chair RMCs and Core Working Groups for assigned products with minimal oversight.
- Represent Pfizer WWS in internal and external forums (including regulatory authorities and business partners) as appropriate.
- Evaluate safety data from any source with minimal oversight; identify/analyze safety signals and present medical evaluations and benefit-risk assessments to appropriate forums.
- Provide disease-area specific pharmacovigilance expertise for assigned business unit products.
- Independently prepare action plans to address risk and benefit-risk issues, often requiring cross-functional collaboration.
- Review and approve safety documents, including those related to the benefit-risk profile of Pfizer products.
- Ensure consistency of safety risk messaging across indications and business units; represent SSRM on due diligence activities and coach others.
- Identify opportunities to standardize safety surveillance and risk management processes.
- Innovate and implement novel approaches to safety surveillance and risk management across the portfolio; participate in continuous improvement and safety sciences initiatives.
- Support inspection readiness by providing data to project managers for metrics and activity tracking.
Qualifications:
- MD degree with at least 4+ years’ experience in medical and/or scientific and/or pharmacovigilance and/or drug development roles (including patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification).
- Focus areas may include Internal Medicine, Rare Disease, and/or Inflammation and Immunology.
- Thorough understanding of safety risk management, including applicable regulations and guidance.
- Comprehensive knowledge of the drug development process and post-marketing experience across the product lifecycle.
- Ability to influence internal and external stakeholders; act independently while seeking guidance as needed.
- Demonstrated leadership in day-to-day activities and ability to influence, coach, and guide others in a matrixed environment.
- Effective verbal and written communication skills.
Required/Preferred Technical Skills:
- Understanding of aggregate safety data and signal assessment methodology; ability to perform benefit-risk assessments.
- Ability to conduct safety data review/assessment, clinical safety signal identification, and risk identification and management.
- Understanding of the scientific basis for therapies and drug-induced diseases.
- Strong scientific/medical knowledge and fluency in the medical literature.
- Ability to integrate data for benefit/risk decision-making.
- Understanding of statistics and analytical tools.
- Knowledge of global safety and regulatory issues relevant to business or clinical research-based compound development.
Benefits:
- Eligible for participation in Pfizer’s Global Performance Plan (bonus target 22.5% of base salary) and share-based long-term incentive program.
- 401(k) plan with Pfizer matching contributions and additional Pfizer retirement savings contribution.
- Paid vacation, holiday, and personal days; paid caregiver/parental and medical leave.
- Health benefits including medical, prescription drug, dental, and vision coverage.
Work Location:
- Hybrid role; live within commuting distance and work on-site ~2.5 days/week.
Relocation:
- Relocation assistance may be available based on business needs and/or eligibility.
- Oversee and perform proactive safety surveillance and risk management to detect and evaluate product safety signals, perform risk assessment, and implement safety risk minimization.
- Partner with internal functions involved in benefit-risk management (e.g., Regulatory, Quality, Clinical, Medical, Corporate Audit) to enable “one medical voice.”
- Serve as a safety point of contact for Asset Teams and chair Risk Management Committees (RMCs) to ensure unified safety communications.
- Chair RMCs and Core Working Groups for assigned products with minimal oversight.
- Represent Pfizer WWS in internal and external forums (including regulatory authorities and business partners) as appropriate.
- Evaluate safety data from any source with minimal oversight; identify/analyze safety signals and present medical evaluations and benefit-risk assessments to appropriate forums.
- Provide disease-area specific pharmacovigilance expertise for assigned business unit products.
- Independently prepare action plans to address risk and benefit-risk issues, often requiring cross-functional collaboration.
- Review and approve safety documents, including those related to the benefit-risk profile of Pfizer products.
- Ensure consistency of safety risk messaging across indications and business units; represent SSRM on due diligence activities and coach others.
- Identify opportunities to standardize safety surveillance and risk management processes.
- Innovate and implement novel approaches to safety surveillance and risk management across the portfolio; participate in continuous improvement and safety sciences initiatives.
- Support inspection readiness by providing data to project managers for metrics and activity tracking.
Qualifications:
- MD degree with at least 4+ years’ experience in medical and/or scientific and/or pharmacovigilance and/or drug development roles (including patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification).
- Focus areas may include Internal Medicine, Rare Disease, and/or Inflammation and Immunology.
- Thorough understanding of safety risk management, including applicable regulations and guidance.
- Comprehensive knowledge of the drug development process and post-marketing experience across the product lifecycle.
- Ability to influence internal and external stakeholders; act independently while seeking guidance as needed.
- Demonstrated leadership in day-to-day activities and ability to influence, coach, and guide others in a matrixed environment.
- Effective verbal and written communication skills.
Required/Preferred Technical Skills:
- Understanding of aggregate safety data and signal assessment methodology; ability to perform benefit-risk assessments.
- Ability to conduct safety data review/assessment, clinical safety signal identification, and risk identification and management.
- Understanding of the scientific basis for therapies and drug-induced diseases.
- Strong scientific/medical knowledge and fluency in the medical literature.
- Ability to integrate data for benefit/risk decision-making.
- Understanding of statistics and analytical tools.
- Knowledge of global safety and regulatory issues relevant to business or clinical research-based compound development.
Benefits:
- Eligible for participation in Pfizer’s Global Performance Plan (bonus target 22.5% of base salary) and share-based long-term incentive program.
- 401(k) plan with Pfizer matching contributions and additional Pfizer retirement savings contribution.
- Paid vacation, holiday, and personal days; paid caregiver/parental and medical leave.
- Health benefits including medical, prescription drug, dental, and vision coverage.
Work Location:
- Hybrid role; live within commuting distance and work on-site ~2.5 days/week.
Relocation:
- Relocation assistance may be available based on business needs and/or eligibility.