Medical Mgr. PSS

3 years

0 Lacs

Posted:5 days ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Job Overview

Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period; and may manage a team.

Summary Of Responsibilities

  • Undertake primary medical review of cases, including medical assessment of the case for seriousness, lists/labeling, causality, adverse event coding and narrative review.
  • 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.
  • 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.
  • Performs aggregate medical review and signal detection/analysis activities, as required.
  • Actively engage with writing team to ensure quality and compliance SLAs are met through coaching, mentoring and timely feedback.
  • Contribute to RFPs, case studies and white papers as and when required.
  • Participate in client meetings and communications along with the Project team including Drug Safety Meetings and Signal Analysis Meetings, as required.
  • Establish an excellent working relationship with the client medical team including managers/lead(s), as required.
  • Work closely with pharmacovigilance colleagues (including Subject Matter Experts) to ensure appropriate medical interpretation and consistency are applied to aggregate reviews.
  • And all other duties as needed or assigned.

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 #+ or higher
  • Writing / Reading: English at ILR level 4 or higher

Experience (Minimum Required)

  • At least 3 years of safety experience (case processing, medical review, clinical safety).
  • Knowledge and understanding of regulatory requirements for Clinical Research/ Pharmacovigilance.
  • Knowledge and understanding of ICH-GCP guidelines.

Preferred Qualifications Include

  • At least 2 years of practicing medicine in a clinical setting.
  • Aggregate safety experience (including aggregate medical review, signal detection and risk management).

Physical Demands/Work Environment

  • Travel Requirements:
  • Regional.
  • % of the time less than 5%.
  • % of the above that requires overnight stay: 75% of above travel.
  • Travel is primarily to where: Regional for client meetings.
Learn more about our EEO & Accommodations request here.

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Fortrea

Pharmaceuticals

Durham

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