医疗安全医师

Medical Safety Physician
6-month assignment
100% Remote
What are the three most important qualifications: Argus experience, self starter, experience in pharmacovigilance and infection disease vaccines
Licenses/Certifications: A Valid medical license (active or inactive), or equivalent, from the country or region in which he/she resides and works

Description
Delivers medical, clinical and scientific advisory expertise in clinical research studies and post marketing programs (RWI). Signal detection and aggregated reporting.

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.

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

Experience
Typically requires 5 - 7 years of prior relevant experience.

Knowledge
Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience.
Typically viewed as having a specialty within discipline.

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

Skills & Abilities:
• 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

Physical Demands:
Sit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects.
Perform continuous operation of a personal computer for four hours or more.
Use hands and fingers to handle and manipulate objects and/or operate equipment.

All your information will be kept confidential according to EEO guidelines.
Originally posted on Himalayas