Manager – Safety Surveillance Research Scientist

Manager – Safety Surveillance Research Scientist

Requirements

• 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 at least 1 year experience in the pharmaceutical industry, academia, and/or regulatory agencies, or Master’s degree in Epidemiology/Quantitative Public Health Discipline with at least 2 years’ experience in the pharmaceutical industry, academia, and/or regulatory agencies.
• In-depth understanding of and expertise in epidemiologic methods, including observational and experimental study designs and analysis, and appropriate sample size calculation methodology.
• Experience writing epidemiological sections of scientific documents such as research summaries, publications, grant proposals, risk management plans, etc.
• 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.

Responsibilities

• Contribute to the design and implementation of real-world, *de novo*, or hybrid design studies intended to quantify risks potentially associated with Pfizer products or to assess the effectiveness of risk mitigation activities. Complexity of study designs will be lower in comparison to other levels within the SSR organization.
• Contribute to the development of post-approval safety studies required as a condition for product approval or to investigate signals arising post-approval. Volume and complexity of these studies will be lower in comparison to other levels within the SSR organization.
• Contribute to the design and implementation of other epidemiology strategies to investigate safety signals arising post-approval, such as critical review of publication on Pfizer products and real-world data queries.
• Build skill set to adequately interact with regulatory agencies on safety epidemiologic issues as needed, via written and/or verbal communications.
• As appropriate and with managerial oversight, consult on safety-related issues in pre-approval research strategies, such as defining safety endpoints in standing cohorts.
• Participate in Risk Management Committee activities related to post-approval epidemiology strategies as needed.
• Contribute to epidemiology sections of risk management plans with appropriate oversight from unit lead and/or senior SSR colleagues.
• Support vendor management oversight activities, as applicable, with appropriate oversight from unit lead and/or senior SSR colleagues.
• Present and publish results of safety epidemiological studies at scientific conferences and peer-reviewed journals.
• Work collaboratively with key stakeholders internally (such as Safety Risk Leads, RM CoE Leads, Clinical, Medical, Regulatory) and externally (such as academics, regulators, vendors).
• Support other SSR colleagues as required.
• As appropriate and with managerial oversight, consult on design of key post-approval safety studies required by single-country health authorities outside the US and EU.
• May be responsible for negotiating and overseeing observational study budgets.
• Participate in internal and external initiatives related to safety epidemiology.

Preferred Qualifications

• Practical experience with implementation of observational or experimental studies.
• Demonstrated ability to negotiate scientific and operational decisions with cross-functional teams, external collaborators; supports regulatory interactions.
• Experience in applying epidemiologic methods to study the safety of medicines preferred.
• Experience participating in internal strategic initiatives and/or representing Pfizer in select external initiatives.