Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Specialist I

Fortrea
Fortrea
4-5 years
Not Disclosed
Bangalore, India
10 April 22, 2026
Job Description
Job Type: Full Time Education: B.Pharm. or Post-Graduation (Microbiology/Quality Assurance/Biochemistry/Biotechnology) 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:

Drug Safety Associate / Pharmacovigilance Specialist


Company:

Fortrea


Job Overview:

The Drug Safety Associate supports Clinical Safety and Pharmacovigilance (PV) operations, managing the end-to-end adverse event (AE) reporting process from clinical trials and post-marketing sources. The role ensures accurate case processing, timely regulatory submissions, and high-quality safety data management in compliance with global regulations.


Key Responsibilities:

Adverse Event (AE) Processing:

  • Manage receipt and processing of AE/SAE reports from:
    • Clinical trials
    • Post-marketing (spontaneous reports)
  • Perform data entry into safety databases and tracking systems
  • Review cases for completeness, accuracy, and reporting requirements
  • Identify missing clinical information and follow up

Medical Coding & Narrative Writing:

  • Write patient safety narratives
  • Code adverse events using MedDRA
  • Assess listedness against product labels (for marketed products)

Regulatory Reporting:

  • Process and submit expedited safety reports (SAEs/ESRs)
  • Ensure compliance with global regulatory timelines
  • Submit reports to:
    • Regulatory Authorities
    • Ethics Committees
    • Investigators and stakeholders

Periodic Reporting & Documentation:

  • Support preparation of:
    • Periodic Safety Reports (PSRs)
    • PSURs, DSURs, IND annual reports
  • Maintain safety tracking systems and project files
  • Assist in preparing safety listings and reports

Data Reconciliation & Quality Control:

  • Perform database reconciliation with Data Management teams
  • Conduct quality/peer review of safety cases
  • Identify trends and recommend corrective actions

Signal Detection & Safety Analysis:

  • Support signal detection and trend analysis
  • Assist in evaluating cumulative safety data
  • Contribute to safety reviews for DSMBs and regulatory submissions

Process, Compliance & Audits:

  • Follow SOPs, Work Instructions, and PV guidelines
  • Support audits and inspection readiness
  • Contribute to CAPA (Corrective and Preventive Actions)

Training & Team Support:

  • Train and mentor junior team members
  • Participate in project and client meetings
  • Support development and updates of safety plans (SMPs, reconciliation plans)

Qualifications (Minimum Required):

  • Degree in Life Sciences / Pharmacy / Nursing / Medical Sciences (preferred)

OR combinations of education + experience:

  • Non-degree + 2 years safety experience or 4–5 years relevant experience
  • Associate degree + 2 years safety experience or 3–4 years relevant experience
  • Bachelor’s degree + 1–2 years safety experience or 2–3 years relevant experience
  • Master’s degree + 1–2 years safety experience or 2 years relevant experience
  • PharmD + 1–2 years safety experience (residency/fellowship considered)

Experience Required:

  • Experience in AE/SAE case processing
  • Familiarity with:
    • Safety databases
    • Regulatory submissions
    • Pharmacovigilance processes

Skills & Competencies:

  • High attention to detail and accuracy
  • Strong written and verbal communication skills
  • Knowledge of medical and drug terminology
  • Understanding of:
    • ICH Guidelines
    • GCP (Good Clinical Practice)
    • Global safety reporting requirements
  • Ability to work independently and in teams
  • Proficiency in MS Office and basic computer skills

Work Environment:

  • Office-based role
  • Travel requirement: ~5% (including occasional overnight stays)

Key Compliance Note:

  • Must adhere to global pharmacovigilance regulations and internal SOPs
  • Ensure timely and accurate reporting to maintain patient safety