This role develops and executes post-approval pharmacoepidemiology/real world evidence research strategies to assess potential safety risks and investigate new safety signals, assess effectiveness of risk management, ensure compliance with global regulatory commitments, and inform benefit-risk decisions about Pfizer medicines.
- Influence the external environment regarding best practices for safety epidemiological studies using real world evidence (e.g., scientific conferences and peer-reviewed journals)
- Design and implement other epidemiology strategies to investigate safety signals arising post-approval, such as critical review of publication on Pfizer products and real world data queries
- Mentor or support other SSR colleagues as required
- Interact with regulatory agencies on safety epidemiologic issues as needed, via written and/or verbal communications
- May be responsible for negotiating and overseeing observational study budgets
- Post-approval safety studies required as a condition for product approval or to investigate signals arising post-approval
- Consult on design of key post-approval safety studies required by single-country health authorities outside the US and EU Oversee vendor activities, as applicable
- Participate in Risk Management Committee activities related to post-approval epidemiology strategies as needed
- Consult on safety-related issues in pre-approval research strategies, such as defining safety endpoints in standing cohorts
- Work collaboratively with key stakeholders internally (such as Safety Risk Leads, RM CoE Leads, GME, Clinical, Medical,
- Regulatory) and externally (such as academics, regulators, vendors)
- Oversee contributions to epidemiology sections of risk management plans
- Design and implement database, de novo, or hybrid design studies intended to quantify risks potentially associated with
- Pfizer products or to assess the effectiveness of risk mitigation activities
- Participate/lead internal and external initiatives related to safety epidemiology
- Experience writing epidemiological sections of scientific documents such as research summaries, publications, grant proposals, risk management plans, etc.
- Doctoral degree in Epidemiology/Quantitative Public Health Discipline or Doctor of Medicine (MD or equivalent) with a Masters degree in Epidemiology/Quantitative Public Health Discipline, with 2 years or more experience in the pharmaceutical industry, academia, and/or regulatory agencies.
- Experience in applying epidemiologic methods to study the safety of medicines preferred.
- Demonstrated ability to negotiate scientific and operational decisions with cross-functional teams, external collaborators; supports regulatory interactions.
- Independently serve as safety research lead of projects with some regulatory/methodologic complexity such as enhanced surveillance or drug utilization; for less complex projects, lead independently with minimal mentorship.
- Experience participating in internal strategic initiatives and/or representing Pfizer in select external initiatives
- In-depth understanding of and expertise in epidemiologic methods, including observational and experimental study designs and analysis, and appropriate sample size calculation methodology.
- Practical experience with implementation of observational or experimental studies.
Vacancy Type: Full Time
Job Location: Markham, Ontario, CA
Application Deadline: N/A