ProductLife Group is seeking an experienced Senior Medical Writer to join its Pharmacovigilance and Medical Writing team. The role focuses on preparing and reviewing complex regulatory and safety documents while ensuring compliance with global regulatory requirements, GVP, ICH guidelines, client requirements, and company SOPs.
Job Details:
Company/Organization: ProductLife Group
Job Position: Senior Medical Writer
Job Location: Not specified
Work Mode: Not specified
Employment Type: Not specified
KEY RESPONSIBILITIES
- Prepare and review PADER, RMP, PSUR/PBRER, DSUR, Signal Reports, Benefit-Risk Evaluation Reports, PSUSA responses, and other safety documents.
- Draft responses to regulatory authority requests and enquiries.
- Conduct literature analysis and interpret complex clinical and scientific data.
- Support clients, projects, aggregate reporting plans, audits, inspections, and bid discussions.
- Contribute to SOPs, CAPA activities, quality metrics, training, and process improvement.
ELIGIBILITY & QUALIFICATIONS
- MD, Pharmacist, or Bachelor’s/Master’s degree in Life Sciences such as Immunology, Microbiology, Bacteriology, or a related field.
- Academic training in Pharmacovigilance is preferred.
- Minimum 4 years of Pharmacovigilance experience.
- Medical Writing experience and aggregate safety reporting experience are strongly preferred.
- Strong knowledge of pharmacovigilance regulations, GVP, ICH guidelines, signal management, and benefit-risk assessment.
- Excellent communication, analytical, organizational, and scientific writing skills.
HOW TO APPLY
Interested and eligible candidates can apply online through the official ProductLife Group careers page: