Medical Mgr. PSS

Fortrea; Pune District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Fortrea is seeking a seasoned pharmacovigilance professional to provide medical safety expertise in post-marketing activities. You will review cases, ensure regulatory compliance, and train a case processing team while collaborating with the writing and project teams.

The role emphasizes risk assessment, signal detection, and client-facing interactions, with travel involvement regionally. Strong English communication is required.

Qualifications

• Bachelor's degree in medical science or MD/DO or equivalent.
• At least 3 years of safety experience (case processing, medical review, clinical safety).
• Knowledge of regulatory requirements for Clinical Research/Pharmacovigilance and ICH-GCP.
• English language skills: ILR level 4 writing and higher, speaking at ILR level #+ or higher.

Responsibilities

• Perform primary medical review of cases for seriousness, causality, and coding.
• Perform secondary QA review of cases and measure quality, identify error trends and training needs.
• Update and document daily case data and feedback to trackers/tools for workflow management.
• Provide training and guidance to the case processing team on medical aspects of case processing.
• Engage with writing team to ensure quality and compliance SLAs are met.
• Contribute to RFPs, case studies and white papers as required.
• Participate in client meetings and communications with the Project team.

Skills

Medical safety

Case processing

Medical review

Regulatory knowledge

ICH-GCP guidelines

Training

Team management

English proficiency

Education

MD/DO or equivalent

Bachelor's degree in medical science

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)

• Bachelors 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).

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.

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