Job Description:

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.

Job Responsibilities:

Influence the external environment regarding best practices for safety epidemiological studies using real world evidence (e.g., scientific conferences and peer-reviewed journals)
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
Mentor or support other SSR colleagues as required
Interact with regulatory agencies on safety epidemiologic issues as needed, via written and/or verbal communications
May be responsible for negotiating and overseeing observational study budgets
Post-approval safety studies required as a condition for product approval or to investigate signals arising post-approval
Consult on design of key post-approval safety studies required by single-country health authorities outside the US and EU Oversee vendor activities, as applicable
Participate in Risk Management Committee activities related to post-approval epidemiology strategies as needed
Consult on safety-related issues in pre-approval research strategies, such as defining safety endpoints in standing cohorts
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)
Oversee contributions to epidemiology sections of risk management plans
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
Participate/lead internal and external initiatives related to safety epidemiology

Job Requirements:

Experience writing epidemiological sections of scientific documents such as research summaries, publications, grant proposals, risk management plans, etc.
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.
Experience in applying epidemiologic methods to study the safety of medicines preferred.
Demonstrated ability to negotiate scientific and operational decisions with cross-functional teams, external collaborators; supports regulatory interactions.
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.
Experience participating in internal strategic initiatives and/or representing Pfizer in select external initiatives
In-depth understanding of and expertise in epidemiologic methods, including observational and experimental study designs and analysis, and appropriate sample size calculation methodology.
Practical experience with implementation of observational or experimental studies.

Job Details:

Company: Pfizer

Vacancy Type: Full Time

Job Location: Markham, Ontario, CA

Application Deadline: N/A

Apply Here

Jobseve.online

Report Job