IQVIA Hiring for Medical Safety Dir in QC Department

IQVIA is hiring for the role of Medical Safety Dir for its Bangalore and Kolkata locations. This role is focused on providing medical expertise for pharmacovigilance services across assigned clinical trials and standalone safety projects.

Job Description

The Medical Safety Director will participate in medical safety activities with appropriate oversight from management or senior medical safety directors. The role also involves global project leadership where multiple medical safety advisors are required, along with mentorship support for junior medical safety staff.

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.
• Serve as an internal consultant to pharmacovigilance case processing teams on supported projects.
• Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile.
• Provide coding review of AEs, past medical history, concomitant medications or other medical data listings to verify and medically vet clinical data.
• Represent safety and clinical data review findings during client meetings.
• Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports and US Periodic Reports.
• Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies.
• Provide medical oversight for label development, review and change.
• Provide medical support and attendance at Data Safety Monitoring Board Meetings.
• Attend and contribute medical safety evaluation on Safety Monitoring Committees.
• Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document.
• Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments.
• Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract.
• Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
• Act as Global Safety Physician or Assistant or Back-up on projects as assigned.
• Serve as the Global Lead for a medical safety project requiring a team of medical safety advisors, including responsibility for project-specific training, operational delivery, project communication and quality control.
• Attend project meetings, medical safety team meetings and client meetings as requested.
• Ensure coverage for all medical safety deliverables within regulatory or contracted timelines.
• Provide medical escalation support for medical information projects and EU Qualified Persons for Pharmacovigilance projects.
• Provide 24hour medical support as required on assigned projects.
• Maintain awareness of medical-safety-regulatory industry developments.
• Participate in the review of Requests for Proposal, vetting, proposing and budgeting of medical safety services.
• Attend bid defenses and other client meetings to promote and sell medical safety services.

Qualification

• Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req.
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research, including regulations and guidelines related to safety and good clinical practice.
• Knowledge of clinical trials and pharmaceutical research process.
• Ability to establish and meet priorities, deadlines and objectives.
• Skills in providing consultation and advice on multiple assignments, along with initiative and flexibility.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref.

Experience

Three (3) years of clinical practice experience, such as graduate medical training, with four (4) additional years in the pharmaceutical or associated industry in any role. An equivalent combination of education, training and experience is also required.

About IQVIA

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. The company creates intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Learn more at https://jobs.iqvia.com

How to Apply

Interested candidates can apply online through the IQVIA Workday application link below.