Senior Medical Safety Advisor (Pharmacovigilance)
Job ID: R1524203
Employment Type: Full-Time
Work Mode: Home-Based / Remote
Location: Bengaluru, India (Additional locations available)
Experience Required: 5–8 Years
Function: Medical Safety | Pharmacovigilance | Drug Safety
Industry: Clinical Research | Pharmaceuticals | Life Sciences
Job Overview
IQVIA is seeking an experienced Senior Medical Safety Advisor to provide expert medical oversight in the evaluation and interpretation of safety data across clinical development and post-marketing phases. This role plays a critical leadership position within the pharmacovigilance organization, supporting safety surveillance, aggregate reporting, signal detection, and regulatory compliance across assigned products and therapeutic areas.
The position requires strong clinical judgment, in-depth pharmacovigilance expertise, and the ability to collaborate across global, matrixed teams to ensure patient safety and regulatory adherence throughout the product lifecycle.
Key Responsibilities
Perform comprehensive medical review of clinical trial and post-marketing adverse events, including seriousness, expectedness, causality assessment, coding validation, and narrative development
Review and medically approve Analyses of Similar Events (AOSE) for expedited safety cases in compliance with global regulatory requirements
Conduct medical validation of safety data including AEs, SAEs, ADRs, medical history, and concomitant medications
Act as a medical consultant to pharmacovigilance case processing and safety operations teams
Review clinical protocols, Investigator Brochures, and Case Report Forms (CRFs) to ensure appropriate safety data capture
Lead and contribute to aggregate safety evaluations such as DSURs, PBRERs, RMPs, ad hoc regulatory reports, and literature surveillance
Oversee safety surveillance activities and ensure maintenance of product watch lists, reference safety information, expectedness lists, and labeling documents
Ensure compliance with global regulations, SOPs, contracted timelines, and quality standards
Support and lead training initiatives, audit readiness, inspections, and product transitions
Review and approve Project Safety Plans and Medical Monitoring Plans as applicable
Represent medical safety findings in internal and client-facing meetings
Act as Lead Safety Physician or provide backup support across assigned projects
Provide medical escalation support, including collaboration with EU QPPVs and medical information teams
Participate in signal detection strategy discussions and safety issue evaluations
Maintain awareness of evolving pharmacovigilance regulations and industry best practices
Provide 24-hour medical safety support for assigned programs, as required
Required Qualifications
Medical degree from an accredited and internationally recognized medical institution
Minimum 3 years of post-degree clinical practice experience (residency and postgraduate training may be considered)
Minimum 2 years of experience in the pharmaceutical industry, pharmacovigilance, CRO, or clinical research environment
Strong foundational knowledge of clinical medicine and therapeutic areas
In-depth understanding of global pharmacovigilance regulations, including ICH, GCP, and safety reporting requirements
Proven experience with Individual Case Safety Reports (ICSRs) and aggregate safety reports
Proficiency in safety databases and pharmacovigilance systems
Strong documentation, analytical, and medical writing skills
Excellent verbal and written communication skills in English
Ability to collaborate effectively with cross-functional teams, clients, investigators, and regulatory authorities
Preferred Qualifications
Valid medical license in the country or region of practice
Prior experience serving as Lead Safety Physician or Medical Safety Reviewer
Experience supporting global regulatory submissions and inspections
About IQVIA
IQVIA is a global leader in clinical research services, healthcare intelligence, and commercial insights for the life sciences industry. Through advanced analytics, technology solutions, and deep scientific expertise, IQVIA accelerates the development and commercialization of innovative therapies that improve patient outcomes worldwide.
Why This Role Matters
This position offers an opportunity to lead critical medical safety activities across global programs, influence patient safety outcomes, and contribute to the advancement of innovative therapies in a highly regulated and impactful environment.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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