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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...
About the Role
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
Risk Management Plans (RMPs)
Benefit-Risk Evaluation Reports
Signal Reports
PSUR/PBRER
DSURs
Addendum to Clinical Overviews
Off-label Use Reports
PSUSA Responses
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