Medical Safety Writer Job at Baxter
Are you searching for a high-impact Medical Safety Writer Job in the pharmaceutical industry? Baxter Careers brings an exciting opportunity for skilled professionals in life sciences to contribute to global healthcare safety. This Life Science Job is ideal for candidates passionate about regulatory writing and drug safety, offering a powerful opportunity for life science graduates to grow in a globally recognized organization.
About the Company
Baxter is a global healthcare organization committed to improving patient outcomes and expanding access to care. Founded on the belief that everyone deserves a healthy life, the company continues to innovate and redefine healthcare delivery. Baxter’s workforce is driven by a shared mission to save and sustain lives, supported by a culture of trust, collaboration, and accountability.
Job Details
- Job Title: Medical Safety Writer
- Requisition ID: JR – 198766
- Location: Ahmedabad, Gujarat, India
- Job Category: GST Operations
- Company: Baxter
Role Overview
The Medical Safety Writer (MSW) is responsible for preparing high-quality aggregate safety reports for submission to global regulatory authorities. The role ensures compliance with regulatory requirements while maintaining accuracy, consistency, and timeliness in safety documentation.
Key Responsibilities
- Prepare and author post-marketing aggregate safety reports, including:
- Periodic Adverse Drug Experience Reports (PADERs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Periodic Safety Update Reports (PSURs)
- Perform quality control reviews of safety reports to ensure accuracy and compliance
- Ensure timely processing and submission of all assigned reports in line with regulatory guidelines and internal timelines
- Support the preparation of responses to regulatory authority queries and assessment reports
- Collaborate with Drug Safety Physicians, EU-QPPV, and Global Patient Safety (GPS) Risk Management teams on safety-related matters
- Coordinate with cross-functional teams such as Regulatory Affairs, Clinical/Medical Affairs, Quality, and Data Management
- Contribute to the development, improvement, and maintenance of standard operating procedures (SOPs) for medical safety writing
- Participate in project teams and cross-functional committees as required
Candidate Profile
The ideal candidate is detail-oriented, scientifically proficient, and capable of managing multiple regulatory writing deliverables while maintaining compliance and quality standards.
Educational Qualification
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related scientific discipline
Experience
2 to 6 years of relevant experience in Medical Safety Writing.
