Senior Medical Safety Advisor
Location: Bengaluru, India
Job Type: Full Time
Job ID: R1471135
Job Description
The Senior Medical Safety Advisor will provide medical expertise in evaluating safety data as part of the pharmacovigilance process. This role involves assessing the medical and scientific relevance of serious adverse event reports and plays a key role in safety surveillance for selected products. As a senior technical leader, the Advisor will also be involved in the preparation of safety reports and collaborating with the Post-Marketing Safety Experts and Safety Surveillance Group.
Key Responsibilities
Adverse Event Review: Perform medical reviews of trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs), including coding, seriousness, causality, and company summary.
Safety Analysis: Compose and review Analyses of Similar Events (AOSE) for expedited cases.
Medical Safety Review: Conduct medical safety reviews of protocols, Investigative Brochures, and Case Report Forms (CRFs).
Aggregate Safety Review: Provide aggregate safety reviews of clinical data, post-marketing safety information, literature reviews, and observational studies (e.g., DSUR, RMP, PBRER).
Team Leadership: Lead and participate in safety team training, product transitions, audit preparations, and knowledge exchange initiatives.
Project Support: Serve as Lead Safety Physician or provide medical escalation support as needed for medical information and pharmacovigilance projects.
Signal Detection: Participate in signal detection efforts and related strategy meetings.
Client and Regulatory Communication: Represent safety and clinical data findings during client meetings and ensure service delivery within regulatory timelines.
Qualifications
Education: Medical degree from an accredited and internationally recognized medical school.
Experience:
At least 3 years of clinical practice after the award of a medical degree (Required).
2 years of pharmaceutical experience (Preferred).
Knowledge:
Sound knowledge of medicine and in-depth understanding of global clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Familiarity with pharmacovigilance processes, ICSR, and aggregate reports.
Skills:
Proficiency in using safety databases and Microsoft Word, Excel, and PowerPoint.
Strong communication skills, both verbal and written.
Ability to establish effective working relationships with stakeholders.
Licensing: A valid medical license (Preferred).
About IQVIA
IQVIA is a global leader in clinical research services, healthcare intelligence, and commercial insights. We connect data, technology, and expertise to accelerate the development and commercialization of innovative treatments that improve patient outcomes worldwide.
Location: Bengaluru, India
Worker Type: Full Time
IQVIA is an equal opportunity employer, committed to diversity and inclusion.
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