Job Description
ROLE SUMMARY
Under the guidance of the SSR unit lead, 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
Under the guidance and supervision of the SSR unit lead, and with the review and approval of all deliverables by SSR management, the SSR scientist will
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-approvalsafety 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
BASIC QUALIFICATIONS
Candidate demonstrates a breadth of diverse experiences and capabilities including: the ability to learn quickly, adapt to a rapidly changing environment, and influence and collaborate with peers 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 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.
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
Other Job Details:
Additional Location Information: New York, NY (primary); Collegeville, PA; Groton, CT; Boston, MA; La Jolla, CA
There is no relocation assistance available for this position.
Work Location Assignment:Hybrid
The annual base salary for this position ranges from $102,900.00 to $171,500.00.* In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. * The annual base salary for this position in Tampa, FL ranges from $92,600.00 to $154,400.00. Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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Job Tags
Holiday work, Permanent employment, Local area, Relocation,