Senior Medical Safety Advisor

Job Title: Senior Medical Safety Advisor

Education Qualification: MBBS/MD.

Work Location: Anywhere in India.

Work Mode: Home Based.

Years of exp: 2yrs Clinical and 1+ yrs of Pharmacovigilance.

Pls note MCI reg is mandatory for all the foreign medical graduates.

Job Overview

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 standalone safety projects with appropriate oversight from management or more senior medical safety directors.

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 products 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 coverages 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

Qualifications

• Required MBBS/MD graduates from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
• Three (3) years of clinical practice experience with 2+ additional years in the pharmaceutical or associated industry in any role is required.
• 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 Preferred.