Job title: Aggregate Report 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).
o Bachelor’s Degree in life sciences and 3+ 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
o Advanced degree preferred (MD, DVM, PharmD, or Master’s/PhD in relevant
· Experience and Attributes:
o Able to execute routine analyses and interpret routine safety analyses with
guidance from team members (analytic skills)
o Has comprehensive understanding of regulatory guidance as it pertains to
presentation and communication of benefit/risk and pharmacovigilance (regulatory
o Is able to synthesize analyses of aggregate or individual patient data into clearly
written text with minimal supervision. (writing skills)
o Has good understanding of medical concepts of the disease and the specific
approach to treatment.
o Makes decisions that require choosing between multiple options to resolve
moderately complex problems, some of which deviate from 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: Wed, 16 Mar 2022 02:26:48 GMT
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