Fortrea Pharmacovigilance Safety Specialist I
- Fortrea Hiring Specialist I Pharmacovigilance in Bangalore
- Company Overview
- Job Role & Responsibilities
- Core Responsibilities
- Advanced Responsibilities
- Eligibility / Qualifications
- Educational Background:
- Experience Required:
- Skills Required:
- Location & Salary
- Application Process
- Why This Role Matters in Healthcare
- Frequently Asked Questions (FAQs)
- 1. Is this role suitable for freshers?
- 2. What is the main responsibility in this role?
- 3. What tools should I know?
- 4. What career growth can I expect?
- Summary
Fortrea Hiring Specialist I Pharmacovigilance in Bangalore
A strong opportunity has opened for candidates looking to build or grow their career in pharmacovigilance and drug safety. Fortrea is hiring Specialist I roles in Bangalore within the Clinical Safety and Pharmacovigilance department.
This role is ideal for candidates with 1–2 years of experience in adverse event processing, safety database management, or clinical safety operations. Candidates from pharmacy, life sciences, and clinical research backgrounds will find this position highly aligned with long-term career growth in drug safety and regulatory domains.
Company Overview
Fortrea is a leading global contract research organization (CRO) focused on delivering clinical development and patient access solutions. The company works with pharmaceutical, biotechnology, and medical device companies worldwide, supporting clinical trials, pharmacovigilance, and regulatory submissions.
With a strong reputation in clinical research and safety data management, Fortrea provides professionals with exposure to global regulatory environments including FDA, EMA, and ICH guidelines.
Job Role & Responsibilities
As a Specialist I in Pharmacovigilance, you will handle end-to-end safety case processing and support global drug safety operations.
Core Responsibilities
- Manage intake and processing of adverse event (AE) and serious adverse event (SAE) reports
- Perform data entry and case tracking in safety databases
- Review case data for completeness, accuracy, and regulatory compliance
- Write patient safety narratives and perform MedDRA coding
- Assess listedness and identify missing clinical information for follow-up
- Ensure timely submission of expedited safety reports to regulatory authorities
- Handle reconciliation activities with data management teams
Advanced Responsibilities
- Assist in preparation of safety reports such as PSUR, DSUR, and IND reports
- Participate in signal detection and safety trend analysis
- Support safety database maintenance and documentation
- Contribute to audit readiness and regulatory inspections
- Assist in CAPA development and root cause analysis
- Support training and mentoring of junior safety staff
Eligibility / Qualifications
Educational Background:
B.Pharmacy, M.Pharmacy, Pharm.D, BSc, MSc (Life Sciences, Nursing, Medical Sciences)
Experience Required:
- 1–2 years of pharmacovigilance or drug safety experience
- Experience in ICSR processing, narrative writing, and safety database usage preferred
Skills Required:
- Strong understanding of pharmacovigilance processes and adverse event reporting
- Knowledge of ICH-GCP guidelines and global regulatory requirements
- Familiarity with MedDRA coding and safety databases
- Good communication and analytical skills
- High attention to detail and accuracy
Location & Salary
- Location: Bangalore, India
- Job Type: Full-time
- Work Environment: Office-based with minimal travel
- Salary: Competitive package based on experience and industry standards
This role offers strong career growth in pharmacovigilance, regulatory affairs, and clinical safety operations, which are among the most in-demand and high-paying domains in the pharmaceutical and CRO industry.
Application Process
Interested candidates can apply through the official Fortrea careers portal:
Apply Here: https://fortrea.wd1.myworkdayjobs.com/Fortrea/job/Bangalore/Specialist-I_26731
Candidates are advised to apply early due to high demand for pharmacovigilance roles.
Why This Role Matters in Healthcare
Pharmacovigilance professionals ensure the safety of medicines by monitoring adverse events and maintaining compliance with global regulatory standards. Their work directly impacts patient safety and supports the development of safe and effective therapies.
Frequently Asked Questions (FAQs)
1. Is this role suitable for freshers?
Yes, candidates with 1–2 years of experience or relevant exposure can apply.
2. What is the main responsibility in this role?
Handling adverse event case processing and ensuring regulatory compliance.
3. What tools should I know?
Safety databases, MedDRA coding, and basic pharmacovigilance systems.
4. What career growth can I expect?
You can progress to roles like Senior Drug Safety Associate, PV Specialist, or Safety Scientist.
Summary
| Category | Details |
|---|---|
| Company | Fortrea |
| Vacancies | Specialist I (Pharmacovigilance / Drug Safety) |
| Required Education | B.Pharmacy, M.Pharmacy, Pharm.D, BSc, MSc |
| Experience | 1–2 Years |
To apply for this job please visit fortrea.wd1.myworkdayjobs.com.
