healthcare
Posted 11 hours agoMedical Physician Specialist II
at Fortrea
Mumbai, IndiaOn-site
Responsibilities
- Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management.
- Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review.
Requirements
- Qualifications (Minimum Required): Bachelor’s degree in medical science or MD or DO or equivalent degree. Fortrea may consider relevant and equivalent
- experience in lieu of educational requirements. Language Skills: Speaking: English at ILR level 3+ or higher. Writing / Reading: English at ILR level 4+ or higher.
- Experience (Minimum Required): Working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures. Knowledge and understanding of regulatory
- requirements for Clinical Research. Knowledge and understanding of ICH-GCP guidelines. Preferred
- Qualifications Include: Good understanding of regulatory
Experience
- Up to 1 year of pharmaceutical industry experience, including pharmacovigilance (case processing, medical review) and / clinical research. 1 to 2 years of Clinical practice experience.
Additional details
- Job Overview: Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. Summary of
- Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs.
- Provide training and guidance to the case processing team on medical aspects of case processing, only after a tenure of 1 year.
- Performs secondary medical review (QC role) and retrospective review of cases reviewed (QA role), as required for measuring quality of deliverables, identifying error trends, training needs and areas of improvement only after a tenure of greater than 1year.
- Performs aggregate medical review and signal detection/analysis activities, as required.
- Enhances existing client relationships whenever possible.
- Creates, maintains, and assumes accountability for a culture of high customer service.
- Participates in process improvement activities across Company.
- Physical Demands/Work Environment: Office or home-based environment, as requested by the line manager.
- Learn more about our EEO & Accommodations request here .