Job Title: Safety Science Analyst (6-Month Contract – HCP Only)
Company: Fortrea
Location: Pune, India
Department: Clinical Safety / Pharmacovigilance
Job Type: Contract (6 Months)
Job ID: 26902
Experience Required: 0–1 Year of Pharmacovigilance or Relevant Pharmaceutical Industry Experience
About Fortrea
Fortrea is a global contract research organization (CRO) specializing in clinical development, pharmacovigilance, and regulatory services for pharmaceutical, biotechnology, and medical device companies. The organization provides comprehensive safety monitoring and clinical research solutions to support drug development and ensure patient safety throughout the product lifecycle.
Role Overview
The Safety Science Analyst supports clinical safety and pharmacovigilance operations by assisting with the management and processing of adverse event reports collected from clinical trials and post-marketing sources. This role focuses on case intake, data entry, narrative writing, coding of adverse events, and submission of safety reports to regulatory authorities and clients within established timelines.
Working within the pharmacovigilance safety framework, the Safety Science Analyst ensures accurate case processing, regulatory compliance, and adherence to quality standards while supporting internal safety teams and sponsor requirements.
Key Responsibilities
Adverse Event Case Intake and Triage
Receive and triage incoming safety reports from various sources including spontaneous reports and clinical trials.
Review safety data for completeness and accuracy before initiating case processing activities.
Safety Case Processing
Perform data entry of safety information into adverse event tracking and safety database systems.
Write patient narratives and ensure accurate documentation of safety cases.
Code adverse events using MedDRA terminology for accurate regulatory reporting.
Listedness and Case Evaluation Support
Assist in evaluating the listedness of adverse events against product labeling for marketed products.
Support medical teams by identifying discrepancies and generating follow-up queries to obtain missing information.
Regulatory Reporting and Submission
Assist in the preparation and submission of expedited Serious Adverse Event (SAE) reports to regulatory authorities, ethics committees, investigators, and clients within required timelines.
Support the preparation and submission of periodic and expedited safety reports as required by global regulatory authorities.
Database Reconciliation and Documentation
Assist in reconciliation of safety databases to ensure data consistency across systems.
Maintain supporting documentation related to global adverse event reporting requirements.
Support document management activities including uploading and archiving safety-related documentation.
Quality and Compliance
Follow pharmacovigilance Standard Operating Procedures (SOPs), Work Instructions (WIs), and internal quality management guidelines.
Ensure compliance with regulatory safety reporting standards and internal operational policies.
Cross-Functional Collaboration
Maintain effective communication with pharmacovigilance and safety science teams across departments.
Support the development of strong working relationships with internal stakeholders and project teams.
Educational Qualifications
Candidates must hold one of the following healthcare or life sciences degrees:
Bachelor of Pharmacy (B.Pharm)
Master of Pharmacy (M.Pharm)
Doctor of Pharmacy (PharmD)
Bachelor of Ayurvedic Medicine and Surgery (BAMS)
Bachelor of Dental Surgery (BDS)
Bachelor of Homeopathic Medicine and Surgery (BHMS)
Bachelor of Science in Nursing (B.Sc Nursing)
Experience Requirements
0–1 year of pharmacovigilance safety case processing experience or relevant experience in the pharmaceutical, biotechnology, or clinical research industry.
Required Skills and Competencies
Strong attention to detail and accuracy in safety data handling.
Good written and verbal communication skills.
Ability to work effectively within team-based environments.
Strong analytical and documentation skills.
Technical Skills
Basic knowledge of pharmacovigilance case processing and adverse event reporting.
Familiarity with MedDRA coding is preferred.
Proficiency in Microsoft Office applications including Word and Excel.
Work Environment
This is an office-based role located in Pune, India. The position requires regular computer usage and collaboration with pharmacovigilance teams in a professional office environment.
Job Location
Pune, India.
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