Pharmacovigilance Quality Review Job at Fortrea
In today’s rapidly advancing pharmaceutical landscape, the role of pharmacovigilance has become more critical than ever. Ensuring drug safety, managing adverse events, and maintaining compliance with global regulatory standards require highly trained professionals. Fortrea, a global leader in contract research services, is currently inviting applications for the position of Functional Quality Specialist I in its Mumbai and Pune locations. Pharmacovigilance Quality Review Job at Fortrea
About Fortrea
Fortrea is a prominent global Contract Research Organization (CRO) that partners with leading pharmaceutical, biotechnology, and medical device companies. With a core focus on clinical trials, pharmacovigilance, and regulatory compliance, Fortrea supports innovation in healthcare while ensuring patient safety and data accuracy. Their operational footprint spans multiple countries, making them a preferred partner for complex clinical development programs. Pharmacovigilance Quality Review Job at Fortrea
Latest Job Opening: Functional Quality Specialist I
Job Role: Functional Quality Specialist I
Location: Mumbai & Pune
Experience Required: 2+ Years
Educational Qualification: Bachelor’s, Master’s, or PhD in Medicine, Pharmacy, Life Sciences, or any related field
Application Mode: Online
Job Published On: June 11, 2025
This opportunity is ideal for professionals with experience in pharmacovigilance and a keen interest in quality compliance and safety reporting.
Key Responsibilities
The selected candidate will play a vital role in supporting Fortrea’s quality review functions in pharmacovigilance. Below are the main responsibilities associated with this role: Pharmacovigilance Quality Review Job at Fortrea
- Quality Review of Pharmacovigilance Cases: Evaluate individual case safety reports (ICSRs) for accuracy, completeness, and regulatory compliance.
- Metric Compilation: Assist in the generation and analysis of quality metrics and identify recurring trends.
- Regulatory Support: Contribute to the preparation and review of regulatory submissions including PSURs (Periodic Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports), and Clinical Study Reports.
- CAPA Involvement: Support the implementation and tracking of Corrective and Preventive Actions (CAPA) related to safety processes.
- Adverse Events Monitoring: Review expedited adverse events and ensure compliance with global safety regulations.
- Audit & Inspection Readiness: Participate in client audits and regulatory inspections, ensuring documentation is complete and accurate.
- Medical Information Handling: Assist in managing medical information queries and product quality complaints.
- Process Enhancement: Contribute to continuous improvement initiatives and support training efforts within the pharmacovigilance team.
Required Skills and Qualifications
To be considered for this position, applicants must meet the following criteria: Pharmacovigilance Quality Review Job at Fortrea
Minimum Requirements
- Education: Bachelor’s, Master’s, or PhD in Pharmacy, Medicine, Life Sciences, or a related discipline.
- Experience: At least 2 years of experience in pharmacovigilance, quality review, or safety writing within the pharmaceutical or biotech industry.
- Regulatory Knowledge: Understanding of GCP (Good Clinical Practice), GVP (Good Pharmacovigilance Practice), ICH guidelines, and international regulations such as FDA and EMA standards.
- Technical Proficiency: Proficient in Microsoft Office tools including Word, Excel, and PowerPoint.
Preferred Qualifications
- Experience in managing quality metrics, CAPAs, and conducting trend analysis.
- Familiarity with medical device reporting requirements.
- Exposure to client-facing roles and audit preparation is a plus.
- Pharmacovigilance Quality Review Job at Fortrea
Work Environment and Additional Information
- Work Type: Office-based position with limited travel (up to 10%).
- Health & Safety: Candidates must comply with COSHH regulations, EC directives, and other internal health and safety protocols.
- Job Nature: Full-time, permanent role with opportunities for career advancement in a globally recognized CRO.
Why Choose a Career in Pharmacovigilance at Fortrea?
Pharmacovigilance is an essential function in drug development and post-marketing surveillance. Working with Fortrea means joining a company that values quality, ethics, and innovation. As a Functional Quality Specialist, you will gain exposure to international clients, cutting-edge safety systems, and real-world regulatory environments.
In addition, Fortrea promotes a collaborative work culture, offers competitive remuneration packages, and provides opportunities for upskilling and professional growth. Their commitment to training and development ensures that employees are well-prepared for industry challenges and equipped with the tools to succeed. Pharmacovigilance Quality Review Job at Fortrea
How to Apply
Interested and eligible candidates can apply through the official Fortrea careers page or through trusted job portals. Ensure that your resume highlights relevant pharmacovigilance experience, regulatory knowledge, and quality management exposure. Include certifications, if any, related to clinical research or drug safety.
Additional Opportunity: Freshers at Lambda Therapeutics
If you’re a fresher or just starting out in pharmacovigilance, Lambda Therapeutics is also currently hiring. This is a great alternative for those who meet the basic academic qualifications but lack industry experience. It’s an excellent way to enter the field and build a solid foundation in drug safety and reporting. Pharmacovigilance Quality Review Job at Fortrea
Conclusion
The Functional Quality Specialist I role at Fortrea presents a golden opportunity for professionals in the pharmacovigilance domain. With its strong emphasis on quality, compliance, and innovation, Fortrea offers a robust platform for career growth and contribution to global healthcare outcomes. If you meet the qualifications and have a passion for drug safety and quality assurance, this is the ideal time to step forward and apply. Pharmacovigilance Quality Review Job at Fortrea
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