Aggregate Safety Report Specialist

7 days ago

Chennai, Tamil Nadu, India beBeeAnalyst Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Description:

The PSSR Aggregate Report Analyst creates documents related to post-marketing safety data to support product development, license application, and post-marketing maintenance. These documents include integrated analyses of safety data in support of aggregate reports, such as 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.


This role requires the ability to 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.


The analyst will assess document requirements, gauge document complexity, and identify information gaps or other potential issues. They will collaborate with project teams to propose strategies to resolve identified issues and provide oversight for internal or external co-authors when required.


The primary responsibility of this role is to communicate WWS's position on resource and timeline needs for assigned documents to project team members and negotiate as needed. The analyst must ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance.


They will drive the document strategies and messages in a collaborative way with relevant project team subject matter experts and ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.


Deliverables will be high-quality, fit-for-purpose documents to the project team within the given timeframe. If overseeing the work of or leading a team of other authors, internal or external, they will be accountable for timely delivery of high-quality documents.


The ideal candidate should have a comprehensive understanding of regulatory guidance as it pertains to presentation and communication of benefit risk and pharmacovigilance. They must be able to synthesize analyses of aggregate or individual patient data into clearly written text with minimal supervision.

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