Job title: Aggregate Reports Analyst
Job description: The PSSR Aggregate Report Analyst creates documents pertaining to post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. These documents include but are not limited to integrated analyses of safety data in support of aggregate reports (e.g., Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc.), responses to regulatory queries on safety topics, post-marketing safety assessments, and Risk Management Plans and relevant documents.
Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents.
Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues.
Provide oversight for internal or external (contractor) co-authors when required for a particular project or assignment (e.g., Canadian Annual Report).
- Bachelor’s Degree in life sciences and 2+ years’ relevant medical experience such as, patient care, clinical trial experience / investigator, academic medicine, specialty training or pharmaceutical industry experience, ideally in safety, regulatory or clinical areas
- Advanced degree preferred (MD, DVM, PharmD, or Master’s/PhD in relevant field)
- Experience and Attributes:
- Able to execute routine analyses and interpret routine safety analyses with guidance from team members (analytic skills)
- Understands regulatory guidance as it pertains to presentation and communication of benefit/risk and pharmacovigilance (regulatory knowledge)
- Is able to synthesize analyses of aggregate or individual patient data into clearly written text under general supervision. (writing skills)
- Has basic understanding of medical concepts of the disease and the specific approach to treatment.
- Makes decisions that require choosing between multiple options to resolve moderately complex problems in standard situations. (analytic skills, and maybe interpersonal skills as well)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Location: Chennai, Tamil Nadu
Job date: Fri, 25 Feb 2022 04:10:46 GMT
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