Job Title: Associate Director, Safety Medical Writing
Location: Remote – India
Company: Parexel
Position Overview:
Parexel is seeking an Associate Director, Safety Medical Writing to lead safety-related documentation and medical device vigilance efforts. This leadership role will oversee both pre- and post-market surveillance (PMS) strategies, ensuring compliance with international regulatory frameworks such as EU MDR and FDA. The ideal candidate will bring extensive experience in medical device safety and guide a team of professionals in safety writing and surveillance activities.
Key Responsibilities:
Strategy & Compliance:
Develop and implement global medical device vigilance strategies.
Ensure strict adherence to regulatory requirements including EU MDR, FDA, and other regional standards.
Safety & Surveillance Management:
Oversee medical device reporting (MDR), individual case safety reports (ICSRs), and PMS activities.
Direct the preparation and review of critical safety documents such as Periodic Safety Update Reports (PSURs) and Clinical Evaluation Reports (CERs).
Lead regulatory interactions and discussions regarding safety data and documentation.
Team Leadership & Training:
Manage a unit of safety professionals in the medical device domain.
Implement effective training programs and oversee staff development.
Cross-Functional Collaboration:
Collaborate with departments such as Clinical Affairs, Regulatory Affairs, and Quality Assurance.
Contribute to integrated product safety strategies across development phases.
Risk & Data Management:
Oversee risk management plans and conduct benefit-risk assessments.
Utilize data analytics tools for signal detection and safety trend analysis.
Strategic Planning:
Participate in long-term planning and advancement of global safety initiatives for device portfolios.
Required Qualifications:
Advanced degree in Life Sciences, Medicine, Pharmacy, or related fields.
At least 8 years of experience in post-market surveillance or medical device vigilance, with 5+ years in leadership roles.
In-depth knowledge of international medical device regulations, especially EU MDR and FDA guidelines.
Comprehensive understanding of safety processes and best practices in the medical device industry.
What Parexel Offers:
A strategic leadership position with global exposure.
Remote flexibility with structured career advancement opportunities.
A collaborative and inclusive work culture.
Competitive salary with a comprehensive benefits package.
Join Parexel to shape the future of global medical device safety. Apply today!
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