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Assoc Dir, Medical Safety

2-3 years
Not Disclosed
10 April 14, 2025
Job Description
Job Type: Full Time Education: MBBS/MD 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, Medical Safety

Company:

IQVIA

Requisition ID:

R1474801

Job Category:

Pharmacovigilance / Medical Safety

Location:

Bengaluru, India
Work Type: Full-time


About the Role:

The Associate Director, Medical Safety provides expert-level pharmacovigilance and clinical safety support across trials and safety-related projects. The role includes medical review responsibilities, strategic safety oversight, leadership of a team of physicians, and contributions to regulatory documents and client communication.


Key Responsibilities:

  • Medical review and clarification of adverse events (AEs/ADRs)

  • Compose/edit/review safety narratives and regulatory safety documents (e.g., AOSEs, IND Annual Reports, DSURs, RMPs)

  • Oversight of product safety profiles and safety data coding (AE, PMH, CM)

  • Provide safety input in project protocols, CRFs, and IBs

  • Serve as Global Safety Physician or backup as assigned

  • Attend client, internal, and safety monitoring meetings

  • Line manage regional medical safety team, providing feedback, support, and development

  • Represent medical safety in internal and external stakeholder discussions

  • Support business development activities (e.g., RFPs, RFIs, bid defenses)


Qualifications:

  • Education:

    • Medical degree (MBBS/MD or equivalent) from an accredited institution (Required)

    • Valid medical license preferred

  • Experience:

    • 3+ years clinical practice (postgraduate medical training)

    • 2+ years pharmaceutical/clinical research industry experience

    • Or equivalent combination of education and experience

  • Skills & Competencies:

    • Knowledge of global pharmacovigilance regulations and clinical research processes

    • Staff management, team leadership, and project oversight experience

    • Strong communication, negotiation, and problem-solving skills

    • Financial awareness and business acumen

    • Strong customer focus and ability to manage complex client relationships

    • Experience in cross-functional and matrix environments


Company Overview:

IQVIA is a global leader in clinical research, real-world evidence, and healthcare intelligence. The company combines data science, technology, and domain expertise to improve healthcare outcomes and accelerate the development of new treatments.