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Looking to advance your career in pharmacovigilance and medical writing? Baxter is hiring experienced Medical Safety Writers (MSW) to support global regulatory submissions. This role is ideal for candidates with hands-on experience in aggregate safety reports like PSUR, PBRER, and PADER and offers a strong growth path in drug safety and regulatory writing.
If you have 2โ6 years of experience in medical safety writing or pharmacovigilance, this opportunity aligns well with global regulatory exposure and cross-functional collaboration.
๐ Job Overview
- Role: Medical Safety Writer
- Company: Baxter
- Experience: 2โ6 Years
- Qualification: B.Pharm, M.Pharm, or Life Sciences
- Job Type: Full-Time
- Location: India (Global/Remote teams may apply)
- Job ID: JR – 198766
๐ Key Responsibilities (Medical Safety Writer)
- Prepare and review aggregate safety reports including:
- Periodic Safety Update Reports (PSUR)
- Periodic Benefit Risk Evaluation Reports (PBRER)
- Periodic Adverse Drug Experience Reports (PADER)
- Ensure regulatory compliance with global submission timelines
- Perform quality control (QC) checks on safety documents
- Respond to health authority queries and assessment reports
- Collaborate with:
- Drug Safety Physicians
- EU-QPPV
- Risk Management teams
- Coordinate with cross-functional teams like:
- Regulatory Affairs
- Clinical & Medical Affairs
- Data Management
- Contribute to SOP development and process improvements
- Participate in internal project teams and safety committees
๐ Qualifications & Eligibility
Education:
- Bachelorโs or Masterโs degree in:
- Pharmacy (B.Pharm / M.Pharm)
- Life Sciences
- Or equivalent scientific discipline
Experience:
- 2 to 6 years in:
- Medical Safety Writing
- Pharmacovigilance documentation
- Aggregate report writing (PSUR/PBRER/PADER)
๐ผ Required Skills
- Strong knowledge of ICH guidelines & global PV regulations
- Expertise in aggregate safety report writing
- Excellent scientific writing and data interpretation skills
- Ability to manage multiple submissions and timelines
- Strong collaboration and communication abilities
๐ฐ Salary (Estimated)
- โน6 LPA โ โน14 LPA (based on experience and expertise in safety writing)
๐ Why Join Baxter?
- Work with a global healthcare leader
- Exposure to international regulatory submissions
- Strong emphasis on career growth in pharmacovigilance
- Collaborative and purpose-driven work culture
- Opportunity to contribute to patient safety worldwide
๐ How to Apply
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