Medical Safety Writer Job at Baxter, Ahmedabad
Interested in a career in pharmacovigilance and medical safety writing? This Medical Safety Writer role at Baxter offers an opportunity to work on global safety reporting and regulatory submissions. You will be responsible for preparing high-quality aggregate safety reports. The role involves collaboration with cross-functional teams in drug safety and regulatory affairs. This Medical Safety Writer Job at Baxter Careers in Ahmedabad is ideal for life sciences professionals aiming to grow in medical writing and pharmacovigilance.
About the Company:
Baxter is a global healthcare company dedicated to saving and sustaining lives. Founded in 1931, Baxter focuses on improving healthcare delivery through innovation, collaboration, and patient-centered solutions. The company operates worldwide, providing essential medical products and services that make a meaningful difference in patients’ lives.
Job Details:
- Job Role: Medical Safety Writer
- Job ID: JR – 198766
- Location: Ahmedabad, Gujarat, India
- Department: GST Operations
- Job Category: Pharmacovigilance / Medical Writing
- Job Type: Full-Time
Key Responsibilities:
- Write and prepare standalone post-marketing aggregate safety reports, such as Periodic Adverse Drug Experience Reports (PADERs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs) and associated reports, for regulatory submission; perform quality control reviews of aggregate safety reports in this Medical Safety Writer Job at Baxter Careers
- Ensure all assigned aggregate safety reports are processed and submitted according to regulatory requirements and internal timelines.
- Assist in the preparation of timely function-specific responses to regulatory authority requests and of function-specific responses to assessment reports from regulatory authorities in this Job in Ahmedabad.
- Collaborate with Drug Safety Physicians, EU-QPPV, and GPS Risk Management Head/Specialist concerning safety issues relative to safety writing activities.
- Interface with other Baxter functional groups, such as Regulatory Affairs, Clinical/Medical Affairs, Quality, Data Management, or other business units as needed.
- Support the creation, improvement, and maintenance of Medical Safety Writing standardized departmental procedures and processes.
- Participate in assigned project teams and committees.
Educational Requirements for this Job:
- Bachelor’s or Master’s degree in Pharmacy
- 2–6 years of experience in medical safety writing
Skills Required:
- Strong knowledge of pharmacovigilance and safety reporting
- Expertise in medical writing and regulatory documentation
- Attention to detail and data accuracy
- Excellent written and verbal communication skills
- Ability to work in cross-functional teams
- Strong time management and organizational skills
- Understanding of global regulatory requirements
Benefits of the Medical Safety Writer Job:
- Opportunity to work with a global healthcare leader
- Exposure to international regulatory and safety reporting processes
- Career growth in pharmacovigilance and medical writing
- Collaborative and inclusive work culture
- Opportunity to contribute to patient safety and healthcare outcomes
- Professional development and learning opportunities
