Associate Medical Safety director

Role & Responsibilities

• Perform medical review and assessment of AEs, SAEs and post-marketing ADRs

• Review narratives, coding, causality, seriousness, expectedness and labeling

• Prepare and medically review AOSEs, DSUR, PBRER, RMP and ad-hoc regulatory reports

• Provide medical guidance to PV case processing teams

• Review safety content of protocols, IBs and CRFs

• Maintain oversight of product safety profiles across lifecycle

• Support signal detection and surveillance activities

• Review and sign off Project Safety Plan and Medical Monitoring Plan

• Lead training, audits, product transitions and knowledge-sharing initiatives

• Provide medical escalation and 24-hour safety support as required

• Represent safety findings in client and internal meetings

• Maintain compliance with GCP, ICH and global PV regulations

Qualification

• MBBS / MD from a recognized medical institution

• Valid medical license preferred

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Experience

• Minimum 3 years of clinical practice after MBBS/MD

• Minimum 2 years of pharmacovigilance / pharma / CRO experience preferred

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Skills

• Strong knowledge of pharmacovigilance and aggregate reporting

• Expertise in ICSR medical review and signal detection

• Good understanding of GCP, ICH and global PV regulations

• Experience with safety databases (Argus, ARIS-G, LSMV etc.)

• Excellent communication and documentation skills

• Strong analytical and leadership abilities

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About the Company

IQVIA is a leading global provider of clinical research services, healthcare analytics, and commercial insights to the life sciences industry. IQVIA helps accelerate the development and commercialization of innovative medical treatments, enabling better patient outcomes and improved population health worldwide.