Associate Medical Safety Director
Company: IQVIA
Location: Thane, India (Home-Based)
Job Type: Full-Time
Job ID: R1532084
Work Model: Remote / Home-Based
Experience Required: Typically 5+ Years (Including Clinical Practice and Pharmaceutical Industry Experience)
Education: Medical Degree (MD or equivalent) from an accredited and internationally recognized medical school
About IQVIA
IQVIA is a global leader in clinical research services, healthcare intelligence, and commercial analytics for the life sciences and healthcare industries. The company combines advanced analytics, technology solutions, and deep scientific expertise to accelerate the development and commercialization of innovative medical treatments. IQVIA partners with pharmaceutical, biotechnology, and healthcare organizations worldwide to improve patient outcomes and advance medical research.
Job Overview
IQVIA is seeking an Associate Medical Safety Director to provide medical expertise within pharmacovigilance and clinical safety operations. This role supports clinical trials and post-marketing safety activities by ensuring accurate safety evaluations, regulatory compliance, and effective risk management for pharmaceutical products.
The Associate Medical Safety Director works closely with cross-functional teams including pharmacovigilance specialists, clinical researchers, regulatory teams, and sponsors to monitor and evaluate drug safety data throughout the product lifecycle.
Key Responsibilities
Conduct medical review and clarification of clinical trial adverse events (AEs) and post-marketing adverse drug reactions (ADRs), including narrative review, coding validation, causality assessment, seriousness evaluation, and expectedness determination.
Prepare and medically review Analyses of Similar Events (AOSE) for expedited safety cases in accordance with regulatory guidelines.
Provide expert medical consultation to pharmacovigilance case processing teams.
Perform aggregate safety reviews by analyzing clinical and safety data to maintain oversight of a product’s safety profile.
Review coding and classification of adverse events, past medical history, concomitant medications, and other clinical data listings.
Present safety findings and clinical data insights during client and project meetings.
Review and edit key regulatory safety documents such as:
Investigational New Drug (IND) Annual Reports
Periodic Safety Update Reports (PSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Development Safety Update Reports (DSURs)
Other periodic regulatory safety reports
Provide medical review and support for Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and development risk management documentation.
Contribute to safety documentation including Integrated Safety Summaries and Common Technical Documents (CTD).
Provide medical oversight for product label development, safety updates, and revisions.
Participate in Data Safety Monitoring Board (DSMB) meetings and Safety Monitoring Committees.
Review and approve Project Safety Plans and Medical Monitoring Plans.
Review protocols, Investigational Drug Brochures (IDBs), and Case Report Forms (CRFs) to ensure appropriate safety content.
Act as Global Safety Physician or backup safety physician on assigned projects.
Attend project meetings, pharmacovigilance discussions, and client safety review meetings.
Ensure all medical safety deliverables are completed within regulatory and contractual timelines.
Provide escalation support for medical information queries and pharmacovigilance activities including support to EU Qualified Persons for Pharmacovigilance (QPPV).
Provide 24-hour medical safety support for assigned projects when required.
Stay updated with evolving pharmacovigilance regulations, clinical research standards, and industry best practices.
Required Qualifications and Skills
Medical degree (MD or equivalent) from an accredited medical institution with training in general medicine.
Minimum three years of clinical practice experience such as postgraduate medical training.
At least two years of experience in the pharmaceutical, biotechnology, clinical research, or pharmacovigilance industry.
Strong understanding of clinical trials, drug development processes, and pharmacovigilance practices.
Knowledge of international regulatory guidelines including Good Clinical Practice (GCP) and global drug safety regulations.
Ability to manage multiple priorities, meet deadlines, and deliver high-quality safety assessments.
Strong analytical, clinical evaluation, and decision-making abilities.
Excellent communication and collaboration skills for working with global teams and clients.
Preferred Qualifications
Valid medical license or equivalent certification from the country or region of practice.
Experience in safety monitoring committees, regulatory submissions, or global pharmacovigilance programs.
Why Join IQVIA
Working at IQVIA offers the opportunity to contribute to global drug safety and clinical research initiatives while collaborating with leading pharmaceutical organizations. Professionals in this role gain exposure to international clinical development programs, regulatory safety frameworks, and advanced pharmacovigilance practices.
Equal Opportunity and Hiring Integrity
IQVIA maintains a strict commitment to ethical recruitment practices and has a zero-tolerance policy for candidate fraud. All information submitted during the application process must be accurate and complete. The company is committed to providing equal employment opportunities and maintaining a workplace free from discrimination and harassment.
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