ROLE SUMMARY
As an experienced medical safety professional, the role requires one to exercise the highest quality of medical judgment to inform a robust understanding of the benefit-risk profile across Pfizer’s portfolio and to advocate for patient safety from first-in-human and throughout a product’s lifecycle. The SSRM Safety Risk Lead is accountable for the global medical safety management of Pfizer products and performs proactive signal detection and evaluation, and risk assessment/minimization to ensure Pfizer products are safe for patients.
He/she will provide organizational leadership within SSRM and within Pfizer, including:
- Performs proactive safety surveillance and risk management to effect product safety signal detection & evaluation, risk assessment and safety risk minimization
- Works with other Pfizer functions engaged in benefit-risk management (Regulatory Affairs, Quality, CMO, Corporate Audit, etc) to enable one medical voice
Articulates clear and informed medical judgement to enable sound business decisions and to enable productive engagement with health authorities.
ROLE RESPONSIBILITIES
- Act as a point of contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing WWS position(s) on safety
- Chairs RMCs and Core Working Groups for his/her assigned products with 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 agreed with Manager
- Evaluates safety data of any source with 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 assigned to him/her
- Assists with preparation of basic action plans to address risk and benefit-risk issues, often requiring cross-functional activity to address safety issues and risk minimization plans
- Prepares and contributes to written safety assessments and benefit-risk evaluations
- Reviews and approves, as appropriate, 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
- 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
QUALIFICATIONS
BASIC QUALIFICATIONS
Professional Experience & Educational Requirements
- Minimum 2 Years of medical experience
PREFFERED QUALIFICATIONS
- Disease area-specific knowledge preferred
- Awareness of safety risk management internal and external environment, including applicable regulations and guidances
- 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
Technical Skills Requirements
- 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
- Ability to lead a cross functional team and lead through example, commitment and enthusiasm in a matrixed environment with minimal oversight
- Strong scientific and medical knowledge, including fluency in the medical literature
- Ability to integrate data to support benefit/risk decision-making
- 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
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
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