Safety Surveillance Research Methods Lead provides pharmacoepidemiology expertise in regulatory and technical strategy for the Safety Surveillance Research (SSR) post-approval pharmacoepidemiology study portfolio, including regulatory communications, feasibility assessment, study design, and interpretation of study results, to ensure high quality and compliance with regulatory obligations and internal Pfizer requirements.
Ensures SSR deliverables are of high quality and in compliance with regulatory commitments and Pfizer policy and SOP requirements
Drives continued innovation for epidemiologic and safety studies, implementing best-in-class approaches for study design, data collection and analysis and alignment with the evolving regulatory, scientific, and technological environment
Works with SSR scientist and SSR Study Implementation Lead to design fit-for-purpose scientific and regulatory communication strategy for post-approval research activities
Conducts detailed review of SSR deliverables for feasibility and technical quality prior to review and sign-off by Head of SSR
Core member of technical review committee
Collaborates with EUQPPV office on alignment of Pfizer policies and SOPs to legislation updates re : PASS and other post-marketing studies
Participates on external working groups (e.g., leadership and membership in PhRMA, IMI, ISPE or other scientific bodies, scientific presentations and publications)
Influences the external environment regarding best practices for safety epidemiological studies using real world evidence (e.
g., scientific conferences and peer-reviewed journals)
including but not limited to, partnering with regulatory agencies and academic opinion leaders, especially in the Asia / Pacific region
Consults on the design, implementation and communication of key RWE safety studies outside the US / EU, such as safety studies conducted in the Asia-Pacific region
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.
Doctoral degree in Epidemiology / Quantitative Public Health discipline or Doctor of Medicine (MD or equivalent) with a Master’s degree in Epidemiology / Quantitative Public Health discipline with 15 years or more in Epidemiology in the pharmaceutical industry.
15+ years experience applying epidemiologic methods to study safety required.
Excellent verbal and written communication skills in English required; excellent communication skills in an Asian language a plus.
Educational or work experience in an Asian country strongly preferred
Demonstrated ability to build and transform scientific / medical / operational teams in a complex matrix structure.
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization regarding complex information and analysis.
Ability to simultaneously manage multiple complex projects, effectively prioritizing and raising key issues as appropriate.
Leading edge knowledge of the principles, concepts and theories of Epidemiology and advanced knowledge of principles and concepts of drug development and post-marketing safety assessment.
Technical Skill Requirements
Demonstrated ability to develop above-asset regulatory and research strategies for safety assesment
Experienced in support of compounds in all phases of drug development and commercialization. This includes leading development of and carrying out epidemiology research strategies for development projects and marketed products, implementing epidemiological studies and evaluations, and working on regulatory dossiers.
Experienced in program oversight and internal and external communication
Experienced in working with key external investigators, academics, vendors and health authorities
Experience working in public-private partnerships or similar collaborations
Demonstrated ability to achieve results in large matrix organizations
Demonstrated ability to influence the direction of the discipline and its uses for regulatory and safety strategies