Associate Medical Safety Director
Job ID: R1523543
Location: Pune, India (Hybrid)
Employment Type: Full-Time
Additional Locations: Available globally
Industry: Pharmacovigilance | Medical Safety | Clinical Research
Job Overview
The Associate Medical Safety Director plays a key role in delivering medical safety oversight across clinical trials and post-marketing safety programs. This position supports end-to-end pharmacovigilance activities, including medical review of adverse events, aggregate safety evaluations, regulatory reporting, and risk management deliverables, under the guidance of senior medical safety leadership.
This role is ideal for experienced physicians seeking to advance their careers in drug safety, regulatory compliance, and global clinical research within a CRO or pharmaceutical environment.
Key Responsibilities
Perform comprehensive medical review and clarification of Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs), including narratives, queries, coding, seriousness, causality, expectedness, and company assessments.
Prepare, review, and medically validate Analyses of Similar Events (AOSE) for expedited regulatory cases.
Act as a medical safety consultant to pharmacovigilance case processing and operational teams.
Conduct aggregate safety reviews of clinical and post-marketing data to maintain continuous oversight of product safety profiles.
Perform medical review of clinical coding (AEs, medical history, concomitant medications) to ensure clinical accuracy and regulatory compliance.
Represent medical safety findings during client, sponsor, and internal stakeholder meetings.
Provide medical review and authorship support for IND Annual Reports, DSURs, PSURs/PBRERs, Periodic Safety Reports, and related regulatory submissions.
Review and support Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and benefit-risk assessments.
Provide medical oversight for product labeling development, review, and updates.
Participate in and provide medical safety input during Data Safety Monitoring Board (DSMB) and Safety Monitoring Committee meetings.
Contribute to Integrated Safety Summaries (ISS) and Common Technical Documents (CTDs).
Review and approve Project Safety Plans and Medical Monitoring Plans per contractual scope.
Conduct safety review of clinical protocols, Investigator’s Brochures (IB/IDB), and Case Report Forms (CRFs).
Serve as Global Safety Physician, back-up, or assistant on assigned projects.
Ensure all medical safety deliverables are completed within regulatory and contractual timelines.
Provide medical escalation support for medical information projects and EU QPPV-related activities.
Deliver on-call medical safety support as required.
Maintain up-to-date knowledge of global medical safety and pharmacovigilance regulations.
Required Qualifications
Medical degree (MBBS/MD or equivalent) from an accredited and internationally recognized medical institution.
Minimum 5 years of total experience, including:
At least 3 years of clinical practice or postgraduate medical training, and
2 or more years of experience in the pharmaceutical, CRO, or life sciences industry in medical safety, pharmacovigilance, or related roles.
Strong knowledge of ICH-GCP, pharmacovigilance regulations, and global safety reporting requirements.
Solid understanding of clinical trial processes, drug development, and regulatory submissions.
Proven ability to manage multiple priorities, deadlines, and complex safety deliverables.
Excellent communication, medical writing, and stakeholder management skills.
Ability to collaborate effectively with cross-functional teams, clients, and regulatory partners.
Preferred Qualification:
Active medical license or equivalent registration in the country of employment.
Work Environment
Hybrid work model with a combination of office-based and remote work.
May require availability for time-sensitive safety activities, including after-hours medical support.
About the Organization
IQVIA is a global leader in clinical research services, healthcare analytics, and commercial insights for the life sciences industry. Through advanced analytics, deep scientific expertise, and innovative technologies, IQVIA supports the development and commercialization of life-changing therapies worldwide.
Equal Opportunity & Integrity Statement
The organization is committed to maintaining integrity, transparency, and fairness throughout the hiring process. All applicants must provide accurate and complete information. Any misrepresentation may result in disqualification or termination in accordance with applicable laws.
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