Medical Physician Specialist II at Fortrea

Mumbai, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

07 Mar, 26

Salary

0.0

Posted On

07 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Review, Adverse Event Coding, Causality Assessment, Regulatory Requirements, Clinical Research, Pharmacovigilance, Signal Detection, Process Improvement, Customer Service, Training, Quality Control, Quality Assurance, Medical Assessment, Case Processing, Documentation, Teamwork

Industry

Biotechnology Research

Description

Job Overview: Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. Summary of Responsibilities: Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review. Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management. 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. 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 requirements relating to Pharmacovigilance. 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. Physical Demands/Work Environment: Office or home-based environment, as requested by the line manager. Learn more about our EEO & Accommodations request here. Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.

Responsibilities

Provide medical safety expertise to Sponsors of drugs and devices during the post-marketing period. Undertake primary medical review of cases and ensure compliance with quality and productivity standards.