Fortrea Hiring for Safety Science Specialist in Bangalore for clinical safety and pharmacovigilance operations
Fortrea, a leading global clinical research organization, has announced a new opportunity for experienced professionals in the field of pharmacovigilance and clinical safety. The organization is hiring for the position of Safety Science Specialist in Bangalore, offering a stable, structured, and growth-oriented work environment. This role is designed for candidates with a strong background in clinical safety operations, adverse event case processing, SAE reporting, and global regulatory compliance. With increasing demand for safety professionals in clinical research and drug development, this position provides exceptional career advancement and exposure to diverse safety functions. Fortrea Hiring for Safety Science Specialist
Published on November 20, 2025, this job opening has already gained significant interest due to its focus on global safety operations, MedDRA coding expertise, narrative writing, and adherence to international pharmacovigilance standards. Candidates with the right experience and qualifications are encouraged to apply as early as possible. Fortrea Hiring for Safety Science Specialist
About Fortrea
Fortrea is known worldwide for its robust clinical research capabilities, global operations, and advanced pharmacovigilance systems. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of drug development. The Safety Science Specialist role plays a critical part in ensuring patient protection, regulatory compliance, and the quality of clinical data submitted for approval. Working at Fortrea means exposure to global teams, structured project methodologies, and innovations in safety reporting and case management. Fortrea Hiring for Safety Science Specialist
Role Overview: Safety Science Specialist
The Safety Science Specialist supports Clinical Safety and PSS operations, managing the complete lifecycle of adverse event case processing. This includes handling clinical trial safety reports, post-marketing safety data, expedited submissions, and periodic reporting requirements. Fortrea Hiring for Safety Science Specialist
Candidates will work alongside medical monitors, project teams, regulators, and data management professionals to ensure that all safety information is captured, processed, evaluated, and reported accurately within required timelines. This role requires meticulous attention to detail, strong documentation skills, and a solid understanding of pharmacovigilance regulations. Fortrea Hiring for Safety Science Specialist
Key Responsibilities
The Safety Science Specialist will be responsible for several critical functions across adverse event case processing, regulatory submissions, auditing, data management, and quality oversight. Detailed responsibilities are explained below. Fortrea Hiring for Safety Science Specialist
1. Adverse Event Case Processing
One of the primary responsibilities of this role is the efficient handling of adverse event and serious adverse event (SAE) cases. This includes both solicited and spontaneous cases originating from clinical trials or post-marketing sources. Major tasks include:
- Receiving, reviewing, and processing clinical safety reports.
- Performing accurate safety data entry into validated safety databases.
- Verifying all source information for completeness and accuracy.
- Identifying clinical relevance, seriousness, and regulatory reporting requirements.
- Preparing high-quality patient narratives meeting global regulatory expectations.
- Coding all adverse events using the latest version of MedDRA terminology.
- Conducting listedness assessments based on reference safety information.
- Coordinating follow-up information requests with medical monitors as required.
Accurate case handling is essential to maintaining compliance with global health authorities. Fortrea Hiring for Safety Science Specialist
2. Safety Reporting and Regulatory Compliance
The Safety Science Specialist is responsible for ensuring that all safety reports are submitted within mandatory regulatory timelines. Responsibilities include:
- Preparing and submitting expedited reports to worldwide regulatory authorities.
- Sending SAE reports to investigators, ethics committees, clients, partners, and internal teams.
- Supporting the creation and distribution of Periodic Safety Reports (PSRs) and Expedited Safety Reports (ESRs).
- Maintaining project-specific adverse event tracking systems.
- Ensuring compliance with study-specific instructions and global PV guidelines.
- Documenting all submission activities for audit-ready reporting.
Regulatory compliance is critical and requires thorough understanding of global safety reporting requirements including ICH, EMA, FDA, and other country-specific guidelines. Fortrea Hiring for Safety Science Specialist
3. Cross-Functional Collaboration
This role involves regular interaction with several departments and external stakeholders. The specialist will:
- Collaborate with Medical Monitors during case review and finalization.
- Coordinate with Data Management teams for database reconciliation and data validation.
- Support Quality Assurance in identifying and resolving process deviations.
- Work with Regulatory Affairs teams during submissions and inspections.
- Contribute to Data Safety Monitoring Boards (DSMBs) by providing requested safety information.
- Assist project management teams in preparing safety documentation.
Effective communication and teamwork are essential for success in this role.
4. Quality Control and Audit Support
To ensure high standards of safety reporting, the specialist will:
- Perform peer quality checks on processed safety cases.
- Identify and escalate data discrepancies, missing information, or potential errors.
- Support internal and external audits, inspections, and regulatory reviews.
- Assist in root-cause analysis and creation of CAPA (Corrective and Preventive Action) plans.
- Ensure consistent adherence to SOPs, Work Instructions, and global guidance documents.
The role requires both accuracy and consistency, as pharmacovigilance operations are highly regulated and subject to frequent scrutiny. Fortrea Hiring for Safety Science Specialist
Required Qualifications
To be eligible for the Safety Science Specialist role, candidates must meet the following requirements:
- 3 to 5 years of pharmacovigilance experience (mandatory).
- Clinical trial case processing experience is essential.
- Educational qualifications include:
- PharmD (with one-year residency or fellowship),
- B.Pharm, M.Pharm,
- BSc or MSc in Life Sciences,
- Nursing, Medical Sciences, or a related discipline.
- Strong understanding of AE and SAE processing workflows.
- Experience working with safety databases.
- Knowledge of regulatory safety reporting requirements.
- Excellent written communication skills, particularly for narrative writing.
- Ability to work independently with minimal supervision.
- High accuracy, attention to detail, and strong analytical skills.
Preferred Skills
While not mandatory, the following skills are highly desirable:
- Proficiency in MS Office applications.
- Familiarity with multiple safety database systems.
- Strong presentation and communication abilities.
- Training and mentoring experience.
- Deep understanding of SOPs, global guidelines, and PV frameworks.
Job Location
- Location: Bangalore, India
- Type: Full-time position
This role offers opportunities for long-term growth and involvement in global pharmacovigilance operations. Fortrea Hiring for Safety Science Specialist
Why Join Fortrea?
Working at Fortrea offers numerous professional advantages:
- Opportunity to work with global safety and clinical teams.
- Exposure to end-to-end pharmacovigilance processes.
- Involvement in critical patient safety activities across clinical studies.
- Structured learning environment and continuous training.
- Stable career path in a rapidly growing industry.
- Collaboration with diverse teams, advanced technologies, and worldwide clients.
Fortrea is committed to ensuring employee development, operational excellence, and high standards of clinical research. Fortrea Hiring for Safety Science Specialist
How to Apply
Interested and eligible candidates can apply for the Safety Science Specialist position through the official online application link provided by Fortrea.
Application Link: Insert the official application URL provided by the recruiter or Fortrea career portal.
Make sure to submit your updated resume, relevant work experience details, and academic qualifications. Early applications are recommended due to high interest in this role. Fortrea Hiring for Safety Science Specialist
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