Senior Medical Writer

About the role

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

Key responsibilities

• Prepare and review aggregate safety reports and regulatory documents such as PADER, RMPs, Benefit‑Risk Evaluation Reports, PSUR/PBRER, DSURs, and off‑label use reports.
• Draft and review responses to regulatory authority requests and enquiries.
• Conduct literature analysis and data interpretation to support medical writing activities.
• Provide scientific expertise, interpret clinical data, and deliver training to cross‑functional teams.
• Coordinate directly with clients, support project estimations, and represent the function during audits and inspections.
• Contribute to SOPs, support CAPA implementation, and monitor quality metrics.

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 medical writing background.
• Proven experience preparing aggregate safety reports and regulatory documentation.

Required skills

• Pharmacovigilance regulations
• GVP (Good Pharmacovigilance Practices) requirements
• ICH guidelines
• Benefit‑risk assessment
• Signal management
• Aggregate safety reporting
• Ability to analyse and interpret complex scientific and clinical information