IQVIA Hiring Associate Medical Safety Director
Associate Medical Safety Director
Qualification: Medical degree (MBBS/MD or equivalent) from an accredited and internationally recognized institution.
Location: Bangalore, India | Ahmedabad, India
Experience: Minimum 3 years of clinical practice experience and 2 years in the pharmaceutical or related industry.
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IQVIA, a leading global provider of clinical research services and healthcare intelligence, is hiring for the position of Associate Medical Safety Director. This role offers an exciting opportunity for experienced medical professionals to contribute to pharmacovigilance operations, global safety assessments, and clinical research oversight. IQVIA Hiring Associate Medical Safety Director
Job Overview
The Associate Medical Safety Director provides medical expertise on pharmacovigilance and safety services, supporting clinical trials and standalone safety projects across multiple therapeutic areas. The role involves close collaboration with cross-functional teams, clients, and regulatory bodies to ensure patient safety and compliance with global regulatory standards. IQVIA Hiring Associate Medical Safety Director
Key Responsibilities
- Conduct medical review and clarification of clinical trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs), including narrative writing, causality assessment, and seriousness evaluation.
- Review and medically assess Analyses of Similar Events (AOSE) and expedited case reports in accordance with global regulatory guidelines.
- Serve as an internal medical consultant to pharmacovigilance and case processing teams.
- Perform aggregate safety reviews of clinical and post-marketing data to maintain ongoing product safety oversight.
- Review and verify coding of AEs, medical history, and concomitant medications for accuracy and clinical relevance.
- Contribute to client meetings, presenting safety and clinical data findings as needed.
- Provide medical input and review for safety regulatory reports, including:
- IND Annual Reports
- Periodic Safety Update Reports (PSURs)
- Development Safety Update Reports (DSURs)
- Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
- Support label development, review, and safety updates in collaboration with global regulatory teams.
- Provide medical expertise to Data Safety Monitoring Boards (DSMBs) and Safety Committees.
- Participate in drafting and reviewing Project Safety Plans, Medical Monitoring Plans, and clinical protocols.
- Act as Global Safety Physician or Backup Safety Physician on assigned projects.
- Maintain 24-hour medical coverage and ensure timely delivery of safety deliverables.
- Stay updated with evolving pharmacovigilance regulations, ICH guidelines, and medical safety trends.
- IQVIA Hiring Associate Medical Safety Director
Qualifications & Experience
- Medical degree (MBBS/MD or equivalent) with curriculum relevant to general medical education.
- At least 3 years of clinical experience plus 2 years in the pharmaceutical or clinical research industry, or equivalent combination of education and experience.
- Valid medical license or equivalent (preferred).
- Strong knowledge of GCP, ICH, and global pharmacovigilance regulations.
- Excellent understanding of clinical trial design, safety data management, and benefit-risk evaluation.
- Strong analytical, problem-solving, and communication skills.
- Ability to handle multiple projects, set priorities, and meet deadlines effectively.
- Strong collaboration and interpersonal skills to work with global teams and clients.
- IQVIA Hiring Associate Medical Safety Director
Why Join IQVIA?
- Be part of one of the world’s largest clinical research organizations.
- Work on global pharmacovigilance projects with exposure to multiple therapeutic areas.
- Opportunity to collaborate with cross-functional experts and leading biopharma clients.
- Competitive compensation and benefits package.
- Professional development opportunities through continuous medical and regulatory training.
- IQVIA Hiring Associate Medical Safety Director
About IQVIA
IQVIA is a global leader in life sciences, healthcare analytics, and technology solutions. The company integrates advanced data science and clinical research expertise to accelerate the development of innovative treatments and improve health outcomes globally. IQVIA Hiring Associate Medical Safety Director
How to Apply
Interested and qualified candidates can apply online through the official IQVIA career portal:
https://jobs.iqvia.com
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