ROLE SUMMARY
The Safety Risk Lead (SRL) will perform proactive Safety Surveillance (SS) and Risk Management with focus on signal detection and evaluation, risk assessment and safety risk minimization.
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.
- Provides disease area specific pharmacovigilance expertise, and applies this to various business unit products assigned to the SRL operating from a SSRM DA-Cluster. Each SSRM DA-Cluster functions as a “Centre of Excellence”.
- Ensures consistency of Safety Risk Messaging for a particular product or class of products, across multiple indications/BUs within the many safety reports and communications for that product. Providing suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements and overall risk messaging of the safety profile to WMS/PSSR Authors.
- Performs ad hoc special scholarly Safety Surveillance & Risk Management activities, rapidly, to meet specific needs in the BUs, such as RRT deliverables/emerging safety issue white papers/product Due Diligence Assessments.
- Identifies opportunities for Consistency and Standards for Safety Surveillance & Risk Management approaches and processes within a DA-Cluster and across BUs, and supporting the piloting and implementation of such.
- Innovates, champions and implements novel approaches to Safety Surveillance & Risk Management across BUs: engages in Continuous Improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements.
- Engages in inspection readiness and support. Provision of data to project managers for metrics and activity tracking.
- Frequently independently performs evaluation of all sources of safety data, identifies and independently analyzes safety signals, and presents evaluation of safety signals and benefit risk assessments to the appropriate forums.
- Contributes SSRM perspective and subject matter expertise to all relevant areas of risk management plans, expert reviews, Health Authority Queries and other documents as required.
- Prepares basic action plans independently to address risk and benefit-risk issues. Handles more advanced/complex plans with direction/coaching.
- Conducts and Represents SSRM on due diligence activities.
- Provides guidance and/or oversight to SSRM colleagues on safety issues. Provides formal and informal education to other SSRM colleagues on key safety and pharmacovigilance topics.
- Represent WSS on safety and benefit-risk issues to external groups including regulatory authorities and business partners.
- Contributes to review and development of intradepartmental policies and procedures as appropriate.
- Initiates, conducts and chairs Risk Management Committee, P-BRC (co-chair) and CWGs with minimal oversight.
- Prepares and contributes to written safety assessments and benefit-risk evaluations.
- Reviews safety assessments/evaluations/contributions prepared by senior manager SRLs and other safety colleagues.
- Completes all assigned activities with minimal guidance.
- Makes decisions based on clinical experience.
- Utilizes knowledge of integrated body systems’ pathophysiology to evaluate the impact of product issues.
- Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities.
- Ensures products fulfil quality medical care.
BASICQUALIFICATIONS
- 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.
- Education: MD (physician) degree required with a minimum 2 years of 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 experience required.
- Demonstrated leadership in day-to- day activities and collaborative skills.
- Demonstrated self-awareness and interpersonal skills for successful execution of the role.
- Demonstrated ability to handle more than one complex project simultaneously, prioritizing well and recognizing key issues.
- Ability in, and track record of, working effectively in an advanced matrix structure, including matrix team leadership/representation preferred.
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Standard travel and working flexible hours can be required ad-hoc.
Work Location Assignment: On Premise
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Medical
