Medical Safety Dir

IQVIA; Kolkata District; On-site; INR 2,000,000 - 3,200,000; Full time

Job summary

IQVIA is seeking a Medical Safety Director to provide medical expertise on pharmacovigilance services across divisions and lead global projects requiring multiple safety advisors.

The role includes oversight of regulatory safety reporting, safety plan reviews, and mentoring junior medical safety staff within a global team.

Qualifications

• Medical degree from accredited school; licence preferred.
• 3 years clinical practice plus 4 years in pharma or related industry or equivalent.
• Knowledge of federal/local regulations and guidelines pertaining to clinical research including safety and GCP.
• Knowledge of clinical trials and pharmaceutical research process.
• Ability to establish priorities, deadlines, and objectives.
• Strong advisory and communication skills; ability to work with diverse teams.
• Ability to build effective relationships with coworkers, managers and clients.

Responsibilities

• Perform medical review of trial-related AEs and ADRs including coding, causality and case summaries.
• Prepare AOSE analyses for expedited cases per regulatory requirements.
• Serve as internal consultant to pharmacovigilance teams on projects.
• Provide aggregate safety data reviews to oversee product safety profile.
• Provide medical review of regulatory safety reports and development risk plans.
• Represent safety findings in client meetings and project reviews.
• Provide medical leadership and mentorship to safety staff on assigned trials.

Skills

Medical degree

Clinical practice experience

Regulatory knowledge

GCP knowledge

Project leadership

Communication skills

Relationship management

Education

Medical degree

Medical license

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.