Associate Medical Safety Director – Kochi, India
Hybrid | Full-Time | IQVIA
Job Summary:
IQVIA is hiring an Associate Medical Safety Director in Kochi to lead and manage pharmacovigilance and clinical safety operations across global projects. This role is ideal for experienced medical doctors with strong clinical practice and drug safety experience, seeking to make a strategic impact in clinical development, post-marketing safety, and regulatory submissions.
Key Responsibilities:
Perform medical review and clarification of AEs/ADRs including seriousness, causality, coding, and narrative quality.
Review and approve safety documents: IND Annual Reports, PBRERs, PSURs, DSURs, RMPs, REMS.
Oversee risk-benefit evaluations, integrated safety summaries, and safety-related labeling content.
Represent IQVIA during client meetings and Data Safety Monitoring Boards (DSMBs).
Review study protocols, Investigator Brochures (IBs), and CRFs for safety relevance.
Provide strategic input on safety deliverables in line with regulatory and contractual timelines.
Act as Global Safety Physician or backup on assigned projects.
Support escalation and medical decisions for global PV and medical information projects.
Contribute to process improvement and maintain awareness of evolving global PV regulations.
Required Skills & Qualifications:
Medical degree from a recognized institution.
Minimum 3 years of clinical practice experience, plus 2 years in pharma or CRO drug safety roles.
Strong knowledge of pharmacovigilance regulations, ICH-GCP, FDA, and EMA safety guidelines.
Experience in authoring and reviewing DSURs, PSURs, and RMPs.
Ability to manage safety activities across multiple studies or programs.
Valid medical license preferred.
Excellent communication and consulting skills; strong attention to detail.
Perks & Benefits:
Collaborate with global cross-functional safety and regulatory teams.
Work on impactful, cutting-edge medical research programs.
Hybrid work model with flexible engagement.
Opportunities for continuous learning and leadership development.
Competitive compensation aligned with global pharmaceutical industry benchmarks.
About the Company:
IQVIA is a world leader in clinical research, real-world evidence, and life sciences consulting. With unmatched healthcare data and analytics, IQVIA helps pharma clients bring innovative therapies to market faster while ensuring compliance, patient safety, and global reach.
Work Mode:
Hybrid – Kochi, India (with some flexibility for remote engagement)
Call-to-Action:
Ready to lead medical safety strategy on global trials? Join IQVIA and contribute to improving patient safety worldwide.
Apply Now at IQVIA Careers →
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