Pharmaceutical Science Job at Fortrea | Apply Now for the Functional Quality Specialist Role
Fortrea is hiring a Functional Quality Specialist II for its Pune operations. This Pharmaceutical Science Job is designed for Life Sciences, Pharmacy, or Medical graduates with at least 3 years of experience in Pharmacovigilance and 1 year in Quality Review. The specialist will be responsible for managing CAPAs, performing safety report quality checks (PSURs, PADERs), and driving process improvements for global regulatory submissions. Applications close on February 6, 2026.
- Job Title: Functional Quality Specialist II
- Location: Pune
- Job Requisition ID: 26374
About The Company
Fortrea is a leading global provider of clinical development and patient access solutions to the pharmaceutical, biotechnology, and medical device industries. Born from the spin-off of Labcorp’s clinical development business, Fortrea brings decades of experience as a premier Contract Research Organization (CRO). The company is dedicated to streamlining the journey from clinical trial to patient delivery, maintaining a strong focus on safety, quality, and regulatory compliance. With a presence in over 90 countries, Fortrea fosters a collaborative, results-oriented culture that empowers professionals to handle complex safety data management and regulatory challenges at scale.
Job Overview
It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service safely and cost-effectively. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989, and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.
Job Responsibilities
- Take ownership of assigned aspects of quality reviews on projects.
- Compile metrics and identify quality trends.
- Assist in addressing periodic client quality reviews and other ad-hoc client quality findings.
- Prepare initial drafts of Corrective and preventive actions.
- Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients.
- Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines.
- Take ownership of assigned CAPAs with respect to ensuring that the actions are closed and produce documentary evidence to that effect in coordination with the project managers.
- Contribute to process reviews, own certain aspects of the reviews and use the results to help identify process improvements and develop process standards.
- Assist in coordinating respective client or external audits of the assigned projects.
- Draft sections of the Quality Management Plan for the assigned project.
- Coordinate with the project team to support the Client during regulatory inspections at client sites with support from the Quality Lead / Quality Manager.
- Implement and promote the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables.
- To respond to/review medical information queries/product quality complaints/general queries that may be received over the telephone, email, fax, etc.
- Guide safety associates in managing voice calls (as required).
- Perform Analysis of data and, if required, suggest strategies for process improvement/excellence.
- All other duties as needed or assigned.
Qualifications
- Bachelor’s/Master’s/PhD degree in Pharmaceutical Science or related area.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience
- Three years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry, primarily in Pharmacovigilance / Safety writing, with at least one year of experience in Peer review/Quality review.
- Knowledge of regulatory requirements, viz. GPV and applicable EU and FDA guidelines.
- In-depth understanding of case processing and assessment.
- Knowledge of Quality Assurance is preferred for the Fortrea Job
- Awareness of lean methodology concepts.
- Technical proficiency withthe Microsoft Office suite of applications.
Preferred Qualifications
- Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred for this Fortrea Job.
- Experience in assessing the quality of a case/safety report from a medical, scientific, and documentation perspective is preferred.
