Pfizer

Director, Epidemiology- Safety Surveillance Research Scientist

Employer
Pfizer
Location
Collegeville, Pennsylvania; Peapack, New Jersey; Groton, Connecticut
Salary
Competitive
Posted
November 20 2020
Ref
4795551
Discipline
Health Sciences
Position Type
Full Time
Organization Type
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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Sunshine Act

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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.

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