Job Description

Group 10

We are seeking an experienced Medical Writer to join our Pharmacovigilance and Medical Writing team.

The successful candidate will be responsible for preparing and reviewing complex regulatory and safety documents, ensuring compliance with global regulatory requirements and company SOPs. This role requires strong scientific expertise, analytical thinking, and the ability to provide medical writing leadership on complex projects.


Key Responsibilities


Medical Writing & Regulatory Documentation

  • Prepare and review aggregate safety reports and regulatory documents, including: PADER
    Risk Management Plans (RMPs)
    Benefit-Risk Evaluation Reports
    Signal Reports
    PSUR/PBRER
    DSURs
    Addendum to Clinical Overviews
    Off-label Use Reports
    PSUSA Responses

  • Draft and review responses to regulatory authority requests and enquiries.

  • Prepare and vali...

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