Associate Medical Safety Director

Project Role:
Associate Medical Safety Director

Work location:

Pan India
Work Mode:
Home Based
Must Have

Skills:

Signal Management and Aggregate Reporting.

Education:

MBBS or MD is mandatory
Experience : 7+ of PV experience which includes 4+ years of signal and aggregate experience

Job Overview:

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 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 meeting
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 Report
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 Meeting
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 project.
Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
24-hour medical support as required on assigned project
Maintain awareness of medical-safety-regulatory industry developments

Qualifications
MBBS or MD from an accredited and internationally recognized medical school with a curriculum relevant to general medical education 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 Prerf.