Medical Writer – Aggregate Reporting

About the role

We are looking for an experienced Medical Writer to join our Pharmacovigilance and Medical Writing team. The role focuses on preparing and reviewing complex aggregate safety reports and regulatory documents while ensuring compliance with global regulations and internal SOPs.

Key responsibilities

• Prepare and review aggregate safety reports (e.g., PSUR/PBRER, DSUR, RMPs, Signal Reports, Off‑label Use Reports).
• Draft and review responses to regulatory authority enquiries and PSUSA requests.
• Conduct literature analysis and data interpretation to support medical writing activities.
• Interpret clinical and scientific data, providing expert support to internal stakeholders and clients.
• Coordinate directly with clients on deliverables, support bid defenses, and represent the function during audits.
• Contribute to SOPs, CAPA actions, and continuous improvement initiatives.

Required profile

• Medical Doctor (MD), Pharmacist, or a Bachelor’s/Master’s degree in Life Sciences (e.g., Immunology, Microbiology).
• Minimum 4 years of experience in Pharmacovigilance, with strong background in Medical Writing.
• Proven experience preparing aggregate safety reports and regulatory documentation.

Required skills

• Pharmacovigilance regulations
• GVP requirements
• ICH guidelines
• Benefit‑risk assessment
• Signal management
• Aggregate safety reporting
• Literature analysis
• Data interpretation