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Associate Director, Safety Medical Writing

8+ years
Not Disclosed
10 April 25, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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!