Director – Drug Safety | Mumbai, India | Full-Time
Location: Mumbai, India
Employment Type: Full-Time, Regular
Work Arrangement: Remote Work Option Available
Requisition ID: R538342
Company Overview
Organon is a global healthcare company committed to advancing women’s health and delivering innovative healthcare solutions. With a $6.5 billion portfolio, Organon focuses on unmet needs in women’s health, expanding access to biosimilars, and improving the lives of patients globally. We are committed to fostering diversity, equity, and inclusion across all levels of our workforce.
Role Overview
Organon is seeking a Director of Drug Safety to lead and oversee pharmacovigilance (PV) and device safety operations. This leadership role is responsible for ensuring the medical assessment of Individual Case Safety Reports (ICSRs) meets global regulatory standards, and that PV processes are consistent, compliant, and scientifically rigorous. The Director will manage both in-house and outsourced PV teams while driving continuous improvement, automation, and regulatory compliance across safety operations.
Key Responsibilities
Medical Review & Device Safety Leadership
Lead and manage the PV Medical Review team, providing oversight and guidance on ICSRs, device safety, and regulatory compliance.
Ensure operational and scientific consistency of in-line medical assessments of safety reports in accordance with global PV regulations.
Provide medical assessment of potential harm associated with drugs and medical devices to support reportability determinations.
Serve as the subject matter expert during audits, inspections, and regulatory interactions.
Provide expertise in device legislation and related PV processes.
Process Development & Compliance
Develop and maintain comprehensive medical review and assessment processes, introducing automation to improve efficiency.
Implement new or updated ICH Guidelines and global PV regulations in medical assessment workflows.
Collaborate cross-functionally to ensure global alignment in PV operations and device safety monitoring.
Contribute to audit readiness, regulatory inspections, and CAPA implementation.
Track metrics and KPIs to ensure compliance and high-quality safety assessments.
Cross-Functional Collaboration
Partner with clinical development, safety teams, and regulatory affairs to escalate safety concerns and provide guidance on complex cases.
Participate in industry benchmarking, working groups, and initiatives to drive process innovation.
Required Qualifications & Experience
Medical Degree (MD/DO/PhD) or equivalent with extensive pharmacovigilance experience.
7+ years of pharmaceutical industry experience in PV, including clinical research and post-marketing environments.
5+ years of leadership experience, supervising or managing PV teams, including vendor oversight.
Strong knowledge of global PV regulations, ICSR processes, and safety databases.
Expertise in medical device regulations and device safety monitoring.
Experience working cross-culturally and supporting diversity and inclusion initiatives.
Clinical specialization in Women’s Health, Internal Medicine, or Pharmaceutical Medicine is preferred.
Desired Skills
Strong analytical and strategic thinking with the ability to influence cross-functional stakeholders.
Experience in process improvement, automation, and PV metrics/KPIs tracking.
Excellent communication skills for audit, regulatory interactions, and internal reporting.
Why Join Organon
Lead a global PV team at a high-impact, patient-centric organization.
Influence the safety and compliance of innovative healthcare products.
Work in a flexible, inclusive, and collaborative environment supporting professional growth.
Contribute to Organon’s mission of improving the health and well-being of women worldwide.
Additional Information
Relocation: Not required
Visa Sponsorship: Not provided
Travel: Not required; must meet local credentialing and vaccination prerequisites
Employee Status: Regular
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