Data Admin Analyst II responsible for data governance and operations at Elevance Health. Collaborating in metadata management and system administration providing insights to enhance data quality.
About the role
- Director role leading safety risk management at Pfizer. Responsible for proactive safety surveillance and collaboration with cross-functional teams to ensure patient safety.
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 Worldwide Safety (WWS)
- Chairs RMCs and Core Working Groups for his/her assigned products with minimal oversight
- Represents Pfizer WWS at internal (e.g. governance and business unit disease area leadership teams) and external forums (e.g. regulatory authority and business partner interactions) as appropriate
- Evaluates safety data of any source with minimal oversight, identifies and analyzes 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 that are assigned
- Prepares action plans independently to address risk and benefit-risk issues, often requiring cross-functional activity to address safety issues and risk minimization plans
- Reviews and approves safety documents including those pertaining to the B-R profile of Pfizer’s products
- Ensures consistency of safety risk messaging for a particular product or class of products, across multiple indications/BUs.
- Represents SSRM on 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 the team as required.
- Makes decisions based on clinical experience
- Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities.
Requirements
- Medical Degree (MD, DO) or equivalent required
- 4+ 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 and/or drug development
- Disease area-specific knowledge in Oncology preferred
- 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 an 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
- Demonstrated leadership in day-to-day activities, including strong interpersonal and collaborative skills
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Benefits
- 401(k) plan with Pfizer Matching Contributions and an 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
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