Associate Medical Safety Director – Kochi
Location: Kochi, India
Work Mode: On-site (Full-time)
Salary/Compensation: Not specified in the job description
Job Summary
IQVIA is hiring an Associate Medical Safety Director to provide expert medical oversight in pharmacovigilance and drug safety. This role involves reviewing adverse events, safety documents, and regulatory reports, while contributing to risk management plans and integrated safety summaries. The candidate will ensure compliance with global safety regulations and act as a key consultant on clinical trials and post-marketing safety activities.
Key Responsibilities
Conduct medical review of adverse events (AEs) and adverse drug reactions (ADRs), ensuring accurate narratives, coding, seriousness, and causality.
Compose and review Analyses of Similar Events (AOSE) for expedited cases based on regulatory needs.
Provide expert consultation to pharmacovigilance teams on ongoing projects.
Perform aggregate safety reviews, evaluating clinical data to maintain product safety profiles.
Review and edit Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).
Offer medical oversight for labeling, safety monitoring, and Data Safety Monitoring Board (DSMB) meetings.
Review and approve Project Safety Plans, Medical Monitoring Plans, and clinical trial protocols for safety compliance.
Act as Global Safety Physician or backup for assigned projects.
Participate in client meetings and ensure timely delivery of medical safety deliverables.
Stay updated on industry developments in medical safety and pharmacovigilance.
Required Skills & Qualifications
Medical degree (MD or equivalent) from an accredited institution.
3+ years of clinical practice and 2+ years in pharmaceutical or drug safety roles.
Strong knowledge of ICH-GCP, pharmacovigilance regulations, and safety reporting standards.
Experience with clinical trials, risk evaluation, and medical monitoring.
Excellent analytical, decision-making, and consultation skills.
Valid medical license (preferred).
Ability to manage priorities and meet tight deadlines.
Perks & Benefits
Opportunity to work on global pharmacovigilance and safety projects.
Collaborative work environment with cross-functional teams.
Professional development and exposure to regulatory safety processes.
Competitive salary and benefits (as per company policy).
Company Description
IQVIA is a world leader in clinical research services and healthcare data analytics. The company partners with pharmaceutical and biotech organizations to accelerate drug development and improve patient outcomes through innovative solutions and regulatory expertise.
Work Mode: On-site (Kochi, India)
Call-to-Action
If you are a qualified medical professional with expertise in pharmacovigilance and clinical safety, apply now for the Associate Medical Safety Director role at IQVIA and take your career to the next level.
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