Associate Director, Safety Medical Writing | Parexel India
Parexel India, a global leader in clinical research, is hiring for the position of Associate Director, Safety Medical Writing. This remote opportunity is ideal for seasoned professionals passionate about medical device vigilance, regulatory compliance, and post-market surveillance. Join a mission-driven organization shaping the future of healthcare through innovation and safety excellence.
About Parexel India
Parexel is a leading global clinical research organization, dedicated to supporting the development of innovative therapies that improve patient lives. In India, Parexel continues to deliver high-quality services in the healthcare and pharmaceutical sectors, driving advancements in medical research and development.
Job Title: Associate Director, Safety Medical Writing
Location: India, Remote
Job ID: R0000032268
Category: Medical Writing
About This Role
Job Description:
We seek an experienced leader to oversee Medical Device Vigilance and Safety services at Parexel India. This role involves developing and implementing pre- and post-market surveillance strategies, ensuring compliance with global regulations, and managing safety reporting for our medical device portfolio.
Key Responsibilities as Associate Director:
- Develop and implement medical device vigilance strategies aligned with regulatory requirements
- Ensure compliance with global regulations for medical devices, including EU MDR, FDA, and other market requirements
- Manage individual case safety reports (ICSRs) and medical device reports (MDRs)
- Direct preparation and review of Periodic safety update reports (PSURs) and Clinical evaluation reports (CERs)
- Lead discussions with regulatory authorities on safety data for medical devices
Qualifications:
- Advanced degree in Life Sciences, Pharmacy, Medicine, Medical devices, or related field
- Minimum 8 years of experience in PMS/medical device vigilance, with at least 5 years in a leadership role
- Extensive knowledge of global medical device regulations, particularly EU MDR and FDA requirements
Keywords: Parexel India, Associate Director, Safety Medical Writing, Medical Device Vigilance, Global Regulations, Job Posting, Post-Market Surveillance, Medical Research, EU MDR, FDA, Regulatory Compliance
