Pharmacovigilance Officer

Why This Role Matters
This Clinical Safety / Pharmacovigilance position offers a unique opportunity to contribute to patient safety and the lifecycle management of pharmaceutical products. You will play a critical role in monitoring, evaluating, and reporting adverse events (AEs) from clinical trials and post-marketing activities. By ensuring accurate and timely safety reporting, you directly support regulatory compliance, safeguard patient health, and help maintain the integrity of clinical studies and marketed products. This role is ideal for individuals looking to grow in the pharmacovigilance or clinical safety field, gain hands-on regulatory experience, and contribute to a global healthcare impact.

Job Description
Fortrea is seeking a detail-oriented Clinical Safety Specialist to join our growing team. The successful candidate will manage and process expedited adverse events (AEs/SAEs), maintain safety databases, support regulatory submissions, and provide high-quality service to clients and internal teams. You will work closely with Clinical Operations, Data Management, and Regulatory teams to ensure compliance with national and international standards, including ICH-GCP, Good Clinical Practice, and global pharmacovigilance requirements.

This role requires a proactive individual capable of handling multiple safety cases while maintaining strict accuracy and regulatory compliance. You will assist with signal detection, safety reporting, quality review, and documentation management, contributing to the overall success of clinical trials and post-marketing safety programs.

Key Features of the Role
• Exposure to global pharmacovigilance and clinical safety operations
• Hands-on experience with AE/SAE reporting, safety database management, and regulatory submissions
• Work across multiple therapeutic areas and client projects
• Opportunity to participate in signal detection and safety trend analysis
• Mentorship and career growth within an international CRO environment
• Involvement in audits, inspections, and CAPA implementation
• Collaborative cross-functional team environment
• Opportunity to support both clinical trial and post-marketing safety projects

Responsibilities
• Manage receipt and processing of all adverse event reports, whether spontaneous or from clinical trials
• Enter safety data into AE databases and tracking systems accurately
• Review adverse events for completeness, accuracy, and expedited reporting readiness
• Write patient narratives and code events using MedDRA
• Determine listedness against product labels for marketed products
• Identify clinically significant missing information and ensure follow-up
• Submit expedited AE/SAE reports to clients, regulatory authorities, ethics committees, and investigators within study-specified timelines
• Perform database reconciliation with Data Management or sponsors as required
• Maintain adverse event tracking systems and ensure all project files are up to date
• Assist with the reporting of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs)
• Participate in signal detection, trend analysis, and pattern recognition activities
• Support preparation of Annual IND reports, PSURs, and DSURs
• Prepare and maintain study safety files for archiving at project completion
• Support audits, inspections, and quality assurance initiatives
• Assist with CAPA development and implementation for safety-related findings
• Mentor and train junior safety staff in AE processing and pharmacovigilance procedures
• Maintain up-to-date knowledge of Standard Operating Procedures (SOPs), Work Instructions (WIs), and regulatory guidelines

Required Qualifications
• PharmD, MS/MA, BS/BA, or Associate degree in Pharmacy, Biological Sciences, Nursing, Life Sciences, or related field
• Relevant experience in safety/pharmacovigilance or CRO/biotech/pharmaceutical industry
• Experience with AE/SAE processing, safety databases, narratives, queries, and regulatory submissions
• Knowledge of ICH Guidelines and worldwide regulatory requirements
• Ability to work independently with minimal supervision
• Excellent written and verbal communication skills

Educational Requirements
• BS/BA, PharmD, or equivalent degree in a health sciences, medical, pharmacy, or life sciences discipline
• Non-degree candidates with 2+ years of clinical safety experience may be considered
• Postgraduate education or relevant certifications in pharmacovigilance or clinical research preferred

Experience and Skills
• Minimum 1–2 years of experience in pharmacovigilance, clinical safety, or related area
• High attention to detail and accuracy in handling sensitive clinical data
• Strong organisational skills with the ability to manage multiple tasks simultaneously
• Proficient in Microsoft Office (Word, Excel, Outlook) and database systems
• Team player with the ability to liaise with clients, investigators, and regulatory personnel
• Understanding of GCP, pharmacovigilance processes, and regulatory safety requirements
• Ability to review cumulative safety data for submissions to regulatory authorities or DSMBs

Salary Insights
• Competitive industry-aligned remuneration based on experience and qualifications
• Opportunities for bonuses or career progression within the pharmacovigilance team
• Additional benefits include professional training, mentorship, and potential travel opportunities (~5%)

Company Overview
Fortrea is a global Contract Research Organisation (CRO) committed to delivering high-quality clinical research and pharmacovigilance services. We support pharmaceutical, biotech, and medical device companies by providing end-to-end clinical trial solutions and safety monitoring services. Our team collaborates with clients, regulatory authorities, and clinical research teams worldwide, ensuring the highest standards of patient safety and compliance.

Our culture is collaborative, professional, and supportive, with opportunities for career growth, continuous learning, and exposure to international regulatory and safety practices.

FAQs

Q: What type of safety experience is required?
A: Experience with AE/SAE processing, writing narratives, database entry, regulatory submissions, and pharmacovigilance procedures is required.

Q: Is travel required?
A: Minimal travel (~5%) may be required for audits or project-related visits, including overnight stays.

Q: Do I need prior clinical trial experience?
A: Prior clinical trial experience is highly desirable but not mandatory if you have relevant pharmacovigilance or safety experience.

Q: What training is provided?
A: Fortrea provides comprehensive training in safety databases, regulatory processes, AE/SAE reporting, and SOP compliance.

Q: Can non-degree holders apply?
A: Yes, candidates with extensive safety experience (2+ years) will be considered.

Application Tips
• Ensure your CV highlights relevant safety, pharmacovigilance, or clinical trial experience
• Include examples of AE/SAE processing, regulatory submissions, or quality/compliance work
• Mention any experience with safety databases, MedDRA coding, or PSUR/DSUR reporting
• Highlight your ability to work independently and manage competing priorities
• Include any relevant certifications, training, or postgraduate qualifications in clinical safety
• Demonstrate communication, attention to detail, and teamwork skills