Medical Safety Physician

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 reputed company medical license (reputed company or inactive), or equivalent, from the country or region in which he/she resides and works

reputed company
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 reputed company aspects of the Medical Safety activities as per scope of work, such as performing medical review and clarification of trial-reputed company 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

• reputed company medical review and clarification of trial-reputed company Adverse Events (reputed company) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company reputed company
  • 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 reputed company being supported
  • reputed company aggregate reviews of safety information, including clinical data, to maintain reputed company of a product’s safety profile
  • reputed company coding review of reputed company, 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 reputed company meetings
  • reputed company 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
  • reputed company medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk
  
  Evaluation and Mitigation Strategies
  • reputed company medical reputed company for label development, review and change
  • reputed company medical support and attendance at Data Safety Monitoring reputed company Meetings
  • Attends and contributes medical safety evaluation on Safety Monitoring Committees
  • reputed company medical safety contributions to the Integrated Safety reputed company or Common Technical Document
  • reputed company 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
  • reputed company Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
  • reputed company as Global Safety Physician or Assistant or Back-up on reputed company as assigned
  • Attend project meetings, medical safety team meetings, and reputed company meetings as requested
  • Ensure coverage for reputed company medical safety deliverables reputed company regulatory or contracted timelines
  • reputed company medical escalation support for medical information reputed company
  • reputed company medical escalation support for EU reputed company Persons for Pharmacovigilance reputed company
  • 24 hour medical support as required on assigned reputed company
  • 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 reputed company job areas typically obtained through advanced education combined with experience.
  Typically viewed as having a specialty reputed company 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 reputed company
  • Knowledge of reputed company and pharmaceutical research process
  • Ability to establish and meet priorities, deadlines, and objectives.
  • Skills in providing consultation and advice on multiple assignments required, as reputed company 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.
  reputed company reputed company operation of a personal computer for four hours or more.
  Use hands and fingers to handle and manipulate objects and/or operate equipment.

reputed company your information will be kept confidential according to EEO guidelines.

Originally posted on Himalayas