Director, Epidemiology- Safety Surveillance Research Scientist

Pfizer
Collegeville, Pennsylvania; Peapack, New Jersey; Groton, Connecticut
Competitive
November 20 2020
4795551
Health Sciences
Full Time
Pharma
At Pfizer, you can truly make progress happen through your work. Ours is a uniquely collaborative global community. It will see you work, learn, and innovate with the first-class talent around you, and around the world.

We are excited to present an opening for a highly visible Director, Epidemiology- Safety Surveillance Research Scientist position within our Safety organization.

Role Summary

The Director, Epidemiology- Safety Surveillance Research Scientist 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

Primary responsibilities include:
  • 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.
  • Independently serve as safety research lead of projects with moderate regulatory/methodologic complexity (e.g., lead and provide recommendations to management re: moderately complex communications with internal and external stakeholders about study design/interpretation).
  • 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.
  • Participates in cross-functional internal and/or external working groups.


Basic Qualifications
  • Doctoral degree in Epidemiology/Quantitative Public Health discipline with 4 years or more experience in the pharmaceutical industry, academia, or other relevant positions following doctoral degree completion.
  • Significant experience applying epidemiologic methods to study safety required.
  • 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.
  • Demonstrated ability to negotiate scientific and operational decisions with cross-functional teams, external collaborators; supports regulatory interactions.
  • Experience participating in internal or external strategic 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.


Preferred Qualifications
  • Five or more years experience in the pharmaceutical industry, academia, or other relevant positions following doctoral degree completion, including experience in regulatory interactions regarding safety research.


Other Job Details:
  • Additional Location Information: Preference for role to be based in New York City, NY but also open to Peapack, NJ, Collegeville, PA or Groton, CT.
  • Eligible for Employee Referral Bonus


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