Safety Risk Lead, Senior Director
Pfizer
Safety Risk Lead, Senior Director – MD Required
Pfizer
full-time
Posted on:
Location Type: Hybrid
Location: Collegeville • Connecticut, New York, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $242,000 - $403,400 per year
Job Level
Senior
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
MD degreepharmacovigilancedrug developmentsafety data reviewsafety data assessmentclinical safety signal identificationrisk identificationrisk managementbenefit-risk assessmentsaggregate safety data
Soft skills
influence stakeholdersindependent decision makingcollaborationcoachingmentoringeffective communicationleadershipinterpersonal skillsorganizational skillscontinuous improvement
