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Sr Medical Manager Pss

Fortrea
Fortrea
5+ years
Not Disclosed
India
10 April 22, 2026
Job Description
Job Type: Remote Education: MBBS and/or MD with at least 2 years of clinical medicine experience. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Job Title:

Medical Safety Physician / Pharmacovigilance Specialist


Company:

Fortrea


Job Overview:

The Medical Safety Physician is responsible for medical review of adverse events, safety monitoring, and pharmacovigilance activities for clinical trials and post-marketing products. The role includes signal detection, aggregate report review, and regulatory safety reporting, while providing medical expertise to project teams.


Key Responsibilities:

Medical Review & Safety Monitoring:

  • Perform medical review of:
    • Serious Adverse Events (SAEs)
    • Adverse Events of Special Interest (AESIs)
  • Conduct ongoing medical and safety monitoring for assigned projects
  • Review laboratory data, coding dictionaries, and clinical data outputs

Regulatory & Aggregate Reporting:

  • Prepare and review aggregate safety reports for global regulatory submissions
  • Author and review ad hoc safety reports for specific safety issues
  • Support submission of safety data to regulatory authorities

Signal Detection & Risk Evaluation:

  • Perform signal detection and evaluation activities
  • Participate in risk assessment processes
  • Identify and analyze potential drug safety issues

Project Support & Collaboration:

  • Provide medical and pharmacovigilance expertise to project teams
  • Collaborate with project physicians and stakeholders
  • Support preparation of investigator meeting materials

Training & Development:

  • Participate in pharmacovigilance training programs
  • Stay updated with drug safety regulations and GCP guidelines

Qualifications (Minimum Required):

  • MBBS and/or MD
  • Minimum 2 years of clinical medicine experience
  • Mandatory experience in Oncology (Clinical Trials or Post-Marketing PV)

Experience Required:

  • At least 5 years of experience in:
    • Pharmaceutical companies
    • Contract Research Organizations (CROs)
    • Health authorities
  • Experience in pharmacovigilance or patient safety

Preferred Qualifications:

  • MD with completed residency program
  • Board-eligible or certified physician
  • Strong knowledge of global pharmacovigilance regulations

Skills & Competencies:

  • Strong medical and clinical evaluation skills
  • Knowledge of drug safety and regulatory requirements
  • Analytical thinking and problem-solving ability
  • Effective communication and collaboration skills
  • Attention to detail

Work Environment:

  • Remote-based role
  • Work timing: 2 PM – 11 PM IST

About the Company:

Fortrea is a global clinical research organization focused on advancing life-saving therapies. The company emphasizes innovation, collaboration, and delivering high-quality outcomes for patients worldwide.


Company Culture:

  • Strong focus on teamwork and excellence
  • Global, collaborative work environment
  • Commitment to innovation in healthcare