Alkem Laboratories is inviting applications for the position of Medical Writer – Risk Management Plan (RMP) in Mumbai. This opportunity is ideal for professionals with experience in pharmacovigilance, regulatory medical writing, and risk management plans.
The selected candidate will be responsible for preparing and managing Risk Management Plans (RMPs) aligned with global pharmacovigilance regulations such as EU GVP. This role involves collaboration with cross-functional teams including Pharmacovigilance, Regulatory Affairs, Clinical Research, Medical Affairs, and Quality to ensure regulatory compliance and patient safety.
This is an excellent opportunity for candidates looking to build a career in regulatory medical writing and drug safety documentation within the pharmaceutical industry.
Key Responsibilities
The Medical Writer – Risk Management Plan will perform the following tasks:
- Prepare, maintain, and manage Risk Management Plan (RMP) schedules and trackers.
- Ensure timely authoring, review, approval, and submission of RMP documents.
- Align RMP content with clinical, non-clinical, and post-marketing safety data.
- Ensure compliance with global regulatory requirements including EU GVP guidelines.
- Draft and coordinate responses to regulatory authority queries related to RMPs.
- Maintain consistency between RMPs and related regulatory documents such as:
- PSUR / PBRER
- SmPC
- Package Leaflets
- Safety Specifications
- Support the evaluation and documentation of additional risk minimization measures.
- Coordinate cross-functional data inputs and review cycles.
- Maintain version control, traceability, and inspection-ready documentation.
- Support regulatory inspections, internal audits, and health authority assessments.
- Liaise with teams including Pharmacovigilance, Regulatory Affairs, Clinical, and Medical Affairs.
Qualifications
Candidates applying for this Medical Writer job in pharmacovigilance should meet the following criteria:
Education
- B.Pharm (Bachelor of Pharmacy)
- BDS (Bachelor of Dental Surgery)
- BAMS (Bachelor of Ayurvedic Medicine and Surgery)
Experience
- 3–5 years of experience in:
- Risk Management Plans (RMP)
- Pharmacovigilance documentation
- Regulatory medical writing
Preferred Skills
- Knowledge of EU GVP guidelines
- Experience in drug safety documentation
- Familiarity with PSUR / PBRER preparation
- Regulatory compliance expertise
- Cross-functional collaboration skills
Salary and Benefits
Although the company has not disclosed the salary, similar Medical Writer – Pharmacovigilance roles in India typically offer:
- Salary Range: ₹8,00,000 – ₹14,00,000 per year
- Career growth in global pharmacovigilance and regulatory affairs
- Exposure to international regulatory submissions
- Opportunity to work with cross-functional clinical and safety teams
Job Details
| Field | Information |
|---|---|
| Position | Medical Writer – Risk Management Plan |
| Company | Alkem Laboratories |
| Location | Mumbai, Maharashtra, India |
| Experience | 3–5 Years |
| Employment Type | Full-time |
| Industry | Pharmaceutical & Life Sciences |
How to Apply
