Job Title: Specialist I – Clinical Safety / Pharmacovigilance
Company: Fortrea
Location: Bangalore, India
Department: Clinical / Drug Safety
Job Type: Full-Time
Job ID: 26731
Experience Required: 1–3 Years in Pharmacovigilance or Clinical Safety
About Fortrea
Fortrea is a leading global contract research organization (CRO) that provides clinical development, pharmacovigilance, and regulatory services to pharmaceutical, biotechnology, and medical device companies worldwide. With deep scientific expertise and advanced clinical capabilities, Fortrea supports sponsors across the entire drug development lifecycle, helping bring innovative and safe therapies to patients while maintaining the highest regulatory and quality standards.
Role Overview
The Specialist I – Clinical Safety supports pharmacovigilance and clinical safety operations by managing adverse event processing, safety data review, and regulatory reporting activities. This role involves handling safety data from both clinical trials and post-marketing sources, ensuring that adverse event reports are accurately processed and submitted to regulatory authorities and stakeholders within required timelines. The position plays an important role in maintaining compliance with global pharmacovigilance regulations and ensuring high-quality safety data management for client projects.
Key Responsibilities
Adverse Event Case Processing
Manage the intake and processing of adverse event reports received from clinical trials or spontaneous sources.
Enter safety data into pharmacovigilance databases and maintain adverse event tracking systems.
Review adverse event reports for completeness, accuracy, and eligibility for expedited reporting.
Prepare patient narratives and perform accurate MedDRA coding of adverse events.
Regulatory Safety Reporting
Determine listedness of adverse events against product labeling for marketed products where applicable.
Process and submit expedited safety reports to regulatory authorities, clients, ethics committees, and investigators within regulatory timelines.
Support the submission of Serious Adverse Event (SAE) reports to stakeholders according to study protocols.
Safety Data Management and Reconciliation
Perform database reconciliation with data management teams or sponsor systems as required.
Maintain project documentation and safety tracking systems to ensure accurate safety reporting records.
Assist in the preparation of safety listings for annual safety reports including IND reports, Periodic Safety Update Reports (PSURs), and Development Safety Update Reports (DSURs).
Quality Control and Compliance
Conduct quality reviews or peer reviews of safety case reports to ensure data accuracy and regulatory compliance.
Support root cause analysis activities and assist in implementing corrective and preventive actions (CAPA).
Ensure adherence to Standard Operating Procedures (SOPs), work instructions, and pharmacovigilance regulatory guidelines.
Signal Detection and Safety Analysis
Participate in early-stage signal detection activities and safety trend analysis where applicable.
Assist with cumulative safety data reviews for regulatory submissions and safety monitoring committees.
Project Support and Collaboration
Support project teams with safety reporting activities and project-specific deliverables.
Participate in client meetings and internal safety discussions related to pharmacovigilance operations.
Assist in preparing safety documentation and files for project completion and archiving.
Educational Qualifications
Bachelor’s, Master’s, or PharmD degree in Pharmacy, Life Sciences, Biological Sciences, Nursing, or a related healthcare discipline.
Equivalent relevant experience in the pharmaceutical, biotechnology, or CRO industry may be considered.
Experience Requirements
1–3 years of experience in pharmacovigilance, clinical safety, or adverse event case processing.
Experience with safety databases, adverse event reporting, and regulatory safety submissions is preferred.
Required Skills and Competencies
Strong understanding of pharmacovigilance processes and adverse event reporting requirements.
Knowledge of medical and drug safety terminology.
Familiarity with Good Clinical Practice (GCP) and ICH pharmacovigilance guidelines.
Understanding of global regulatory safety reporting requirements for clinical and marketed products.
Strong attention to detail and accuracy in safety documentation.
Ability to work independently while collaborating with cross-functional teams.
Technical Skills
Proficiency in Microsoft Office applications including Word, Excel, and PowerPoint.
Experience working with pharmacovigilance safety databases and case processing systems.
Good data entry and documentation management skills.
Work Environment
Office-based work environment with collaboration across global safety and clinical teams.
Occasional travel may be required depending on project requirements.
Job Location
Bangalore, India.
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