Director, Safety Risk Lead
Pfizer
5 hours ago
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Primary Responsibilities:
- Oversee and perform proactive safety surveillance and risk management to detect and evaluate product safety signals, conduct risk assessment, and minimize safety risks.
- Partner with cross-functional Pfizer groups engaged in benefit-risk management (Regulatory, Quality, Clinical, Medical, Corporate Audit, etc.) to deliver one medical voice.
- Serve as a safety point of contact for Asset Teams and chair Risk Management Committees (RMCs) to ensure unified safety communication.
- Chair RMCs and Core Working Groups for assigned products with minimal oversight.
- Represent Pfizer WWS in internal and external forums (e.g., governance/business unit disease area leadership; regulatory authority and business partner interactions).
- Evaluate safety data from any source with minimal oversight; identify and analyze safety signals; present medical evaluations and benefit-risk assessments.
- Provide disease-area specific pharmacovigilance expertise across assigned business unit products.
- Independently prepare action plans to address risk and benefit-risk issues, coordinating cross-functionally to implement safety and risk minimization plans.
- Review and approve safety documents, including those related to product benefit-risk profiles.
- Ensure consistent safety risk messaging across indications/business units; represent SSRM on due diligence and coach others to support business plans.
- Identify opportunities for consistency/standards in safety surveillance and risk management processes.
- Innovate and implement novel approaches for safety surveillance and risk management; participate in continuous improvement and Safety Sciences Research & Communications, including methodological improvements.
- Support inspection readiness by providing data for metrics and activity tracking.
Director Safety Risk Lead (MD Role):
- Make decisions based on clinical experience.
- Assess suitability of biopharmaceutical products for typical physician practice within hospital and non-hospital health systems.
Technical Skill Requirements:
- Understand aggregate safety data, signal assessment methodology, and perform benefit-risk assessments.
- Perform safety data review/assessment, clinical safety signal identification, risk identification, and risk management.
- Understand scientific basis for therapies and drug-induced diseases.
- Lead cross-functional teams in a matrixed environment with minimal oversight.
- Strong scientific/medical knowledge and fluency in medical literature.
- Integrate data to support benefit/risk decision-making; understand statistics and analytical tools.
- Knowledge of global safety/regulatory issues relevant to business or clinical research-based compound development.
Qualifications:
- Required: MD degree with 4+ years’ experience including medical (patient care, clinical trial/investigator, academic medicine, specialty training and/or board certification) and/or scientific and/or pharmacovigilance or drug development.
- Therapeutic area focus may include Internal Medicine, Rare Disease, and/or Inflammation and Immunology.
- Thorough understanding of safety risk management environment, including applicable regulations/guidance.
- Comprehensive knowledge of drug development process and post-marketing safety across the drug lifecycle.
- Ability to influence internal and external stakeholders.
- Ability to act independently while seeking guidance as appropriate.
- Demonstrated day-to-day leadership, interpersonal collaboration, and experience influencing peers, coaching others, and overseeing work for business impact.
- Effective verbal and written communication skills.
Benefits:
- Eligibility for participation in Pfizer’s Global Performance Plan (bonus target 22.5% of base salary) and share-based long-term incentive program.
- 401(k) with Pfizer matching contributions and additional Pfizer retirement savings contribution.
- Paid vacation/holidays/personal days; paid caregiver/parental and medical leave.
- Health benefits including medical, prescription drug, dental, and vision coverage.
Other Job Details:
- Hybrid role; live within commuting distance and work on-site ~2.5 days/week.
- Annual base salary range: $189,200–$315,400.
- Relocation assistance may be available based on business needs/eligibility.
Application Instructions:
- Not provided in the supplied text.
- Oversee and perform proactive safety surveillance and risk management to detect and evaluate product safety signals, conduct risk assessment, and minimize safety risks.
- Partner with cross-functional Pfizer groups engaged in benefit-risk management (Regulatory, Quality, Clinical, Medical, Corporate Audit, etc.) to deliver one medical voice.
- Serve as a safety point of contact for Asset Teams and chair Risk Management Committees (RMCs) to ensure unified safety communication.
- Chair RMCs and Core Working Groups for assigned products with minimal oversight.
- Represent Pfizer WWS in internal and external forums (e.g., governance/business unit disease area leadership; regulatory authority and business partner interactions).
- Evaluate safety data from any source with minimal oversight; identify and analyze safety signals; present medical evaluations and benefit-risk assessments.
- Provide disease-area specific pharmacovigilance expertise across assigned business unit products.
- Independently prepare action plans to address risk and benefit-risk issues, coordinating cross-functionally to implement safety and risk minimization plans.
- Review and approve safety documents, including those related to product benefit-risk profiles.
- Ensure consistent safety risk messaging across indications/business units; represent SSRM on due diligence and coach others to support business plans.
- Identify opportunities for consistency/standards in safety surveillance and risk management processes.
- Innovate and implement novel approaches for safety surveillance and risk management; participate in continuous improvement and Safety Sciences Research & Communications, including methodological improvements.
- Support inspection readiness by providing data for metrics and activity tracking.
Director Safety Risk Lead (MD Role):
- Make decisions based on clinical experience.
- Assess suitability of biopharmaceutical products for typical physician practice within hospital and non-hospital health systems.
Technical Skill Requirements:
- Understand aggregate safety data, signal assessment methodology, and perform benefit-risk assessments.
- Perform safety data review/assessment, clinical safety signal identification, risk identification, and risk management.
- Understand scientific basis for therapies and drug-induced diseases.
- Lead cross-functional teams in a matrixed environment with minimal oversight.
- Strong scientific/medical knowledge and fluency in medical literature.
- Integrate data to support benefit/risk decision-making; understand statistics and analytical tools.
- Knowledge of global safety/regulatory issues relevant to business or clinical research-based compound development.
Qualifications:
- Required: MD degree with 4+ years’ experience including medical (patient care, clinical trial/investigator, academic medicine, specialty training and/or board certification) and/or scientific and/or pharmacovigilance or drug development.
- Therapeutic area focus may include Internal Medicine, Rare Disease, and/or Inflammation and Immunology.
- Thorough understanding of safety risk management environment, including applicable regulations/guidance.
- Comprehensive knowledge of drug development process and post-marketing safety across the drug lifecycle.
- Ability to influence internal and external stakeholders.
- Ability to act independently while seeking guidance as appropriate.
- Demonstrated day-to-day leadership, interpersonal collaboration, and experience influencing peers, coaching others, and overseeing work for business impact.
- Effective verbal and written communication skills.
Benefits:
- Eligibility for participation in Pfizer’s Global Performance Plan (bonus target 22.5% of base salary) and share-based long-term incentive program.
- 401(k) with Pfizer matching contributions and additional Pfizer retirement savings contribution.
- Paid vacation/holidays/personal days; paid caregiver/parental and medical leave.
- Health benefits including medical, prescription drug, dental, and vision coverage.
Other Job Details:
- Hybrid role; live within commuting distance and work on-site ~2.5 days/week.
- Annual base salary range: $189,200–$315,400.
- Relocation assistance may be available based on business needs/eligibility.
Application Instructions:
- Not provided in the supplied text.