Medical Job at IQVIA in Bangalore | Safety Advisor Role
Discover an exciting medical job opportunity with IQVIA in Bengaluru, tailored for healthcare professionals seeking growth in pharmacovigilance and drug safety. As part of IQVIA careers, this role empowers medical experts to contribute to high-impact safety evaluation, clinical data oversight, and regulatory compliance. This position offers an excellent platform for professionals aiming to elevate their expertise through a reputed IQVIA job in global healthcare research.
Job Details:
- Position: Senior Medical Safety Advisor
- Location: Bengaluru, India
- Type: Full time
- Job ID: R1471135
- Work Arrangement: Home-based
About the Company
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Medical Job – Qualifications
- Medical degree from an accredited and internationally recognized institution.
- Minimum 3 years of clinical practice experience post-degree (Residency counts).
- Preferably 2 years of pharmaceutical industry experience.
- Thorough knowledge of Medicine, GCP, ICH guidelines, and pharmacovigilance requirements.
- Familiarity with safety databases and strong computer skills.
- Excellent written and verbal communication abilities.
- Strong ability to collaborate with managers, coworkers, investigative sites, clients, and regulatory agencies.
- Valid medical license preferred.
Job Description
This medical job at IQVIA involves providing medical expertise in evaluating safety data across clinical trials and post-marketing sources. The Senior Medical Safety Advisor determines the scientific relevance of serious adverse event reports within the larger safety profile of therapeutic products. As a senior technical leader within IQVIA careers, the role includes participating in matrix activities, developing aggregate safety reports, and overseeing surveillance for assigned products.
Medical Job – Key Responsibilities
- Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), including narrative content, queries, coding, expectedness, seriousness, causality, and company summary.
- Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.
- Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications, or other medical data listings to verify and medically vet clinical data.
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.
- Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable.
- Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review, and observational studies to maintain oversight of a product’s safety profile (e.g, DSUR, RMP, PBRER, ad hoc regulatory reports, etc).
- Ensure service delivery from a productivity, compliance, and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective.
- Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in a single case assessment.
- Ensure update of watch list, list of expectedness, labeling list/RSIs, etc, for the assigned products and develop such additional capabilities within the team.
- Lead, drive, and participate in training activities, product transitions, audit preparation, and knowledge exchange initiatives.
- Review and sign off on the Project Safety Plan and Medical Monitoring Plan, as applicable, per the medical safety scope agreed in the contract.
- Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable.
- Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable.
- Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable.
- 24-hour medical support as required on assigned projects.
- Maintain awareness of medical safety and regulatory industry developments.
- Provide support and participate in signal detection efforts, e.g., strategy meetings, etc., as applicable.
