Medical Safety Dir

IQVIA LLC; Bengaluru; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

IQVIA LLC in Bengaluru seeks a Medical Safety Director to lead pharmacovigilance activities, perform medical review of AEs/ADRs, and mentor junior staff on global projects.

You will serve as Global Safety Lead on initiatives, provide medical oversight for safety reports and regulatory submissions, and represent safety findings in client meetings. The role requires a medical degree, clinical experience, and strong regulatory knowledge with GCP expertise.

Qualifications

• Medical degree from an accredited and internationally recognized medical school
• 3+ years of clinical practice or equivalent in pharma/industry
• Knowledge of FDA/EMA/local regulations and GCP guidelines
• Understanding of clinical trials and pharmaceutical development processes
• Ability to set priorities, deadlines and objectives
• Strong consultation and advisory skills across multiple assignments
• Proven ability to build relationships with coworkers, managers and clients
• Valid medical license from country/region of residence

Responsibilities

• Perform medical review of trial-related AEs and post-marketing ADRs including causality and seriousness
• Lead global safety projects and mentor junior medical safety staff
• Provide analytics and aggregate reviews of safety data for product oversight
• Represent safety findings in client meetings and with regulatory bodies
• Oversee safety reporting content for Regulatory submissions and risk management plans
• Act as Global Safety Lead on complex projects and provide project training and quality control

Skills

Medical degree

Clinical practice

Regulatory knowledge

Clinical trials knowledge

Prioritization

Consulting skills

Stakeholder management

Medical license

Education

Medical degree from accredited school

Job description

Job Overview

Provide medical expertise on pharmacovigilance services to all divisions as requested. The Medical Safety Director participates in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors. The Medical Safety Director also provides global project leadership on projects requiring multiple medical safety advisors and mentorship to junior medical safety staff.

Essential Functions

• 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 projects being supported
• 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, 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
• Attends and contributes 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; being responsible 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
• Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
• 24hour medical support as required on assigned projects
• Maintain awareness of medical-safety-regulatory industry developments
• Participates in the review of Requests for Proposal, vetting, proposing and budgeting of medical safety services
• Attends bid defenses and other client meetings to promote and sell medical safety services

Qualifications

• Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req
• Three (3) years of clinical practice experience (e.g graduate medical training) with four (4) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining 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 required, as well as 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 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. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.