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Sub-Family Description

Provides medical, scientific, and therapeutic expertise on pharmacovigilance services.

Participates in all aspects of the Medical Safety activities as per scope of work, such as performing medical review and clarification of trial-related Adverse Events including review of analysis of similar events, medical evaluation of post-marketing adverse drug reactions, review medical inputs for into signal management and benefit-risk evaluation of drugs in clinical trial and post marketing set up, safety aggregate report review, safety review of study protocol, investigators brochure and other reference safety information, clinical study report narrative review, providing medical assessment comments etc and serving as an internal consultant for any medical support for pharmacovigilance operations.

JOB OVERVIEW

Job Profile

Provide medical expertise on pharmacovigilance services to divisions as requested. The

Associate 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.

Responsibilities

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
- 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
- 24 hour medical support as required on assigned projects
- Maintain awareness of medical-safety-regulatory industry developments
- Line manage a team of regionally based physicians performing the tasks of a global medical safety physician ensuring operational delivery of assigned projects and career development of direct reports
- Account for financial performance of assigned medical safety projects
- Evaluate assigned staff workload and volume projections in order to ensure appropriate balance of project assignments for direct reports
- Ensure appropriate resourcing and coverage of assigned global projects, regardless of regional holidays
- Ensure that departmental goals, objectives, policies, and procedures are communicated, understood, and implemented
- Supervise assigned direct reports and provides mentoring as required; identifying ongoing training and development needs of assigned staff
- Recommend course of action on management/human resources matters, including salary administration,

transfers, hiring,

terminations, professional development, performance appraisals, and employee counseling

- Participate in the Global Medical Safety Management Team to drive service line growth, differentiation, and strategy
- Represent global medical safety service line to regional stakeholders, internal and external
- Attend key meetings pertinent to service line and maintain connections with key clients of service line
- Serve as a resource and participate in strategic business development activities including presentations to prospective clients,

professional meetings, and other business development activities

- Perform special projects as requested by management

Education

Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education

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📍 India