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Safety Science Specialist

3-5 years
upto 9 LPA
5 Nov. 21, 2025
Job Description
Job Type: Full Time Education: B.Pharm, M.Pharm, Pharm D., BSc., MSc. 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

Safety Science Specialist – Fortrea | Bangalore, India

Job ID: 255848
Location: Bangalore
Employment Type: Full-Time
Experience Required: Fresher candidates eligible
Application Deadline: 12 December 2025

Role Overview

Fortrea is seeking a Safety Science Specialist to support global pharmacovigilance and clinical safety operations. This role involves managing adverse event data from clinical trials and post-marketing sources, ensuring timely processing, and maintaining compliance with global regulatory requirements. The position is well-suited for freshers aspiring to build a strong foundation in drug safety, safety operations, and clinical research.

You will contribute to safety case processing, expedited reporting, regulatory submissions, quality review, and cross-functional collaboration within clinical and post-marketing safety programs.


Key Responsibilities

Adverse Event Case Processing

  • Receive, process, and track adverse event and serious adverse event reports from clinical trials and spontaneous sources.

  • Perform accurate data entry into safety databases and ensure completeness of records.

  • Assess cases for expedited reporting in accordance with global regulatory timelines.

  • Write clear, compliant patient narratives and code events using MedDRA.

  • Evaluate listedness against product labels for marketed products.

  • Identify missing clinical information and coordinate follow-up with relevant stakeholders.

  • Ensure cases receive timely medical review and quality assessment.

Expedited and Periodic Reporting

  • Prepare and submit expedited safety reports (SAEs/ESRs) to clients, regulatory agencies, ethics committees, investigators, partners, and third-party vendors within study-defined timelines.

  • Support preparation and submission of Periodic Safety Reports (PSRs).

  • Maintain adverse event tracking systems and safety documentation.

  • Coordinate database reconciliation with Data Management teams.

Safety Operations Support

  • Assist in maintaining study-specific documentation, central files, tracking logs, and safety metrics.

  • Support safety committee or DSMB data preparation requirements.

  • Participate in quality reviews, peer reviews, and contribute to trend identification and corrective action planning.

  • Assist in audit and inspection preparation and support ongoing compliance activities.

  • Ensure adherence to all pharmacovigilance SOPs, work instructions, guidelines, and regulatory directives.

Cross-Functional Collaboration

  • Build strong working relationships across pharmacovigilance, clinical operations, data management, regulatory teams, and project stakeholders.

  • Support client communication and project updates as required.

  • Contribute to organizational knowledge with consistent, high-quality work and team collaboration.


Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Biological Sciences, Medical Sciences, Nursing, or a related discipline.

  • Freshers may apply; prior exposure or academic experience in pharmacovigilance, clinical research, or safety data management is beneficial.

  • Knowledge of AE/SAE processing, narrative writing, regulatory timelines, and safety databases is an added advantage.


Skills and Competencies

  • Strong attention to detail and accuracy.

  • Ability to work independently with minimal supervision.

  • Effective written and verbal communication skills.

  • Strong organizational and time-management skills.

  • Familiarity with MS Office applications.

  • Willingness to work collaboratively within global and cross-functional teams.

  • Ability to understand and follow regulatory and procedural requirements.


Job Location

Bangalore, India