Fortrea Hiring Specialist I Pharmacovigilance Jobs with global CRO exposure in drug safety and clinical research.
Company Overview
Fortrea is a leading global clinical research organization (CRO) delivering innovative solutions across drug development and post-marketing lifecycle management. With decades of expertise in clinical trials and pharmacovigilance, the company supports pharmaceutical, biotech, and medical device organizations worldwide.
Fortrea is known for its strong safety science capabilities, advanced data platforms, and global regulatory expertise. The company offers a collaborative work environment where professionals can build rewarding careers in drug safety, clinical research, and regulatory sciences. Fortrea Hiring Specialist I Pharmacovigilance Jobs
Job Location & Employment Type
- Location: Bangalore, India
- Employment Type: Full-time
- Work Environment: Office-based (with minimal travel requirements)
Open Position
Specialist I – Clinical Safety / Pharmacovigilance
Department: Drug Safety / Pharmacovigilance
This role focuses on end-to-end adverse event management, including case processing, regulatory reporting, and pharmacovigilance documentation. It is ideal for candidates looking to grow in global drug safety operations. Fortrea Hiring Specialist I Pharmacovigilance Jobs
Key Roles & Responsibilities
The Specialist I will support pharmacovigilance activities related to clinical trials and post-marketing surveillance, ensuring timely safety reporting and regulatory compliance. Fortrea Hiring Specialist I Pharmacovigilance Jobs
Adverse Event Case Processing
- Receive and process adverse event (AE) reports from clinical trials and spontaneous sources.
- Perform accurate data entry into safety databases and tracking tools.
- Assess reports for completeness, accuracy, and regulatory reporting requirements.
- Write detailed patient narratives and code events using MedDRA terminology.
- Evaluate product listedness against approved labels when applicable.
- Identify missing medical or safety information and initiate follow-up queries.
Regulatory Reporting
- Ensure expedited reporting of serious adverse events (SAEs) within regulatory timelines.
- Submit safety reports to sponsors, regulatory authorities, ethics committees, and partners.
- Support periodic safety submissions such as PSURs, DSURs, and other aggregate reports.
- Maintain compliance with global pharmacovigilance regulations and reporting standards.
Safety Documentation & Compliance
- Maintain adverse event tracking systems and project documentation.
- Support preparation and maintenance of safety study files.
- Assist in database reconciliation with data management teams.
- Participate in safety data reviews and quality checks of processed cases.
- Ensure adherence to SOPs, work instructions, and global safety guidelines.
Data Analysis & Reporting
- Contribute to signal detection and safety trend analysis activities.
- Prepare safety listings and metrics for regulatory submissions and internal reviews.
- Generate monthly safety status reports and project dashboards.
- Support cumulative safety data reviews for oversight committees.
Collaboration & Process Support
- Participate in project meetings and cross-functional safety discussions.
- Assist in updating safety management plans and reconciliation strategies.
- Provide mentoring support to junior safety staff when required.
- Support audit readiness and inspection preparation activities.
- Contribute to CAPA activities and root cause investigations.
Eligibility Criteria
Education
Candidates should hold a degree in one of the following fields:
- Pharmacy
- Life Sciences
- Biological Sciences
- Nursing
- Medical Sciences
- Related healthcare disciplines
Higher degrees such as M.Pharm, MSc, PharmD, or postgraduate medical sciences are advantageous but not mandatory. Fortrea Hiring Specialist I Pharmacovigilance Jobs
Experience
Candidates should have any of the following:
- 1–2 years of pharmacovigilance or safety experience
OR - Relevant experience in pharmaceutical, CRO, or biotech domains such as:
- Clinical data management
- Medical affairs
- Regulatory affairs
- Quality assurance
- Clinical research support
Hands-on experience with AE/SAE case processing is strongly preferred.
Skills Required
- Strong attention to detail and accuracy in data handling.
- Knowledge of pharmacovigilance workflows and safety databases.
- Familiarity with MedDRA coding and safety narratives.
- Understanding of GCP and ICH safety guidelines.
- Awareness of global regulatory reporting requirements.
- Good written and verbal communication skills.
- Strong organizational and time-management abilities.
- Ability to work independently and in team environments.
- Proficiency in MS Office and basic computer tools.
- Understanding of medical and drug terminology is desirable.
Fortrea Hiring Specialist I Pharmacovigilance Jobs
Salary & Benefits
- Salary: As per company norms
- Additional benefits may include:
- Exposure to global safety projects
- Structured career progression in pharmacovigilance
- Professional training and skill development
- Inclusive and collaborative workplace culture
Exact benefits depend on company policy and experience level.
Selection Process
The hiring process generally includes:
- Resume shortlisting
- HR screening round
- Technical interview (drug safety knowledge)
- Final managerial discussion
Interview rounds may vary based on candidate experience and business needs.
How to Apply
Interested candidates can apply through the official Fortrea careers portal before the deadline.
While applying, ensure your resume highlights:
- Pharmacovigilance or safety case processing experience
- Exposure to safety databases and regulatory reporting
- Knowledge of AE/SAE workflows
Important Dates
- Application Deadline: April 30, 2026
Candidates are advised to apply early to avoid last-minute closure.
Why Apply for This Pharma Job?
This Fortrea opportunity is ideal for professionals aiming to build a long-term career in pharmacovigilance and drug safety. Here’s what makes this role valuable: Fortrea Hiring Specialist I Pharmacovigilance Jobs
- Work with a globally recognized CRO
- Exposure to international pharmacovigilance standards
- Hands-on experience with safety databases and reporting
- Opportunity to grow in signal detection and aggregate reporting
- Strong learning environment for early-career drug safety professionals
If you are looking to establish yourself in global drug safety operations, this role offers the right foundation and growth trajectory. Fortrea Hiring Specialist I Pharmacovigilance Jobs
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that publishes verified pharma and clinical research opportunities. We are not affiliated with Fortrea or any hiring organization. Applicants should apply only through official company websites and verify details independently. Fortrea Hiring Specialist I Pharmacovigilance Jobs
Final Call-to-Action
If you have pharmacovigilance experience and want to advance your career in global drug safety, this Fortrea Specialist I role is a strong opportunity. Apply today and move forward in your clinical safety career journey. Fortrea Hiring Specialist I Pharmacovigilance Jobs
