Medical Physician Specialist II
Job reputed company:
reputed company medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period.
reputed company of Responsibilities:
Undertake reputed company 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 reputed company assigned deliverables in line with expected reputed company, compliance, and productivity SLAs and KPIs.
reputed company 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 reputed company 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 reputed company 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.
reputed company 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 reputed company experience.
Physical Demands/Work Environment:
Office or home-based environment, as requested by the line manager.
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