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.ROLE RESPONSIBILITIES
- 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
- Post-approval safety studies required as a condition for product approval or to investigate signals arising post-approval
- 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
- Interact with regulatory agencies on safety epidemiologic issues as needed, via written and/or verbal communications
- 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
- Oversee contributions to epidemiology sections of risk management plans
- Oversee vendor activities, as applicable
- Influence the external environment regarding best practices for safety epidemiological studies using real world evidence (e.g., scientific conferences and peer-reviewed journals)
- 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)
- Mentor or support other SSR colleagues as required
- 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/lead internal and external initiatives related to safety epidemiology
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 Masters degree in Epidemiology/Quantitative Public Health Discipline, with 2 years or more 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.
- Practical experience with implementation of observational or experimental studies.
- 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.
- Demonstrated ability to negotiate scientific and operational decisions with cross-functional teams, external collaborators; supports regulatory interactions.
Other Job Details:
- 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
Additional Location Information: New York, NY; Collegeville, PA; Groton, CT; Peapack, NJ; US - Remote; Milan, Italy; Sandwich, UK; Cambridge, UK; Walton Oaks, UK; Asia - Remote; Europe - Remote; Canada - Remote; LATAM - Remote
#LI-PFE Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & 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, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.