Job Title: Medical Writer Post-Market Surveillance (PMS)
Location: Pune, India
Experience: 3+ Years into medical writing
Salary: Upto 22 LPA
Education Qualification:
- Graduate in Biomedical Engineering or Pharmacy, or MBBS
- Postgraduate in Life Sciences
About the Role:
We are looking for a skilled Medical Writer (PMS) with hands-on experience in drafting and managing post-market surveillance (PMS) documentation for medical devices. The ideal candidate should possess strong analytical and writing skills, as well as the ability to interpret technical, clinical, and medical data to support global regulatory submissions.
Key Responsibilities:
- Draft, review, and update PMS Plans, PMS Reports/Periodic Safety Update Reports (PSURs), Post-Market Clinical Follow-up Reports (PRER), and Canada Summary Reports for medical devices.
- Identify and assess relevant data sources including literature, clinical data, and medical references and incorporate findings into PMS documents.
- Compile, interpret, and submit clinical and post-market documentation to meet international regulatory requirements.
- Collaborate effectively with cross-functional teams such as PMS, Medical Affairs, Literature Search, Regulatory, Risk Management, R&D, Sales, and Marketing.
- Support responses to regulatory authority inquiries and clarification requests related to post-market documentation.
Skills Required:
- Strong understanding of post-market surveillance processes for medical devices
- Proficiency in technical and medical data analysis
- Excellent scientific writing and documentation skills
- Familiarity with global regulatory submission processes
- Strong attention to detail and ability to interpret clinical and technical information
