Fortrea Careers is hiring for the position of Fortrea Functional Quality Associate II in Pune. This Pharmacovigilance and Functional Quality role is ideal for candidates with experience in PV operations, safety writing, quality review, and CAPA management within the pharmaceutical, biotechnology, or CRO industry.
Candidates with backgrounds in Pharmacy, Life Sciences, Nursing, Medical Sciences, or related healthcare domains can apply for this Fortrea Pune job opportunity. Professionals with expertise in adverse event review, case processing, regulatory compliance, and GVP/GCP guidelines will find this role highly relevant.
Job Overview
The Functional Quality Associate II will support quality operations related to pharmacovigilance, safety reporting, regulatory documentation review, and compliance monitoring. The role involves reviewing safety cases, preparing quality metrics, supporting audits, managing CAPA activities, and ensuring adherence to global regulatory standards.
This Fortrea Pharmacovigilance job in Pune also includes responsibilities involving medical information review, product quality complaints, and quality oversight for safety documentation and reporting workflows.
Key Responsibilities
Pharmacovigilance & Safety Review
- Perform quality review of safety reports and adverse event cases
- Review global regulatory safety submissions including:
- PSURs
- PADERs
- Clinical Study Reports
- Core Data Sheets
- Investigator Brochures
- Annual Reports
- Review medical information queries and product quality complaints
- Support expedited adverse event reporting within timelines
Quality & Compliance Activities
- Assist in CAPA preparation and implementation tracking
- Generate quality metrics and identify quality trends
- Support process compliance review and analysis
- Participate in internal and client quality reviews
- Contribute to process improvement initiatives
Audit & Inspection Support
- Coordinate with project teams during audits and regulatory inspections
- Support development of Quality Management Plans
- Maintain documentation and evidence for quality compliance activities
Training & Operational Support
- Assist with training schedules and onboarding support
- Guide safety associates in voice-call management when required
- Perform reconciliation, tracking, and ongoing QC activities
Eligibility Criteria
Educational Qualification
Candidates must possess any of the following:
- B.Pharm
- M.Pharm
- Pharm.D
- BSc Life Sciences
- MSc Life Sciences
- Nursing
- Medical Sciences
- Biological Sciences
- Alternative Medicine
- Related healthcare qualifications
Experience Required
- Minimum 2+ years experience in:
- Pharmacovigilance
- Safety writing
- Quality review
- Case processing
- CRO or pharmaceutical industry operations
Required Skills
Applicants should have:
- Strong understanding of Pharmacovigilance workflows
- Knowledge of:
- ICH Guidelines
- GCP
- GVP
- EU and FDA safety regulations
- Experience in adverse event reporting
- Knowledge of medical and drug terminology
- CAPA management understanding
- Microsoft Office proficiency
- Quality metrics and trend analysis exposure
Candidates with medical device reporting knowledge will have an added advantage.
Salary Details
Based on current industry standards for Functional Quality Associate II Pharmacovigilance roles in Pune, the estimated salary range is:
- โน5.5 LPA โ โน8.5 LPA
Salary may vary depending on experience, PV expertise, quality review exposure, and regulatory knowledge.
Why Join Fortrea?
Fortrea is one of the leading global Contract Research Organizations (CROs) focused on clinical development and patient-centered innovation. Employees benefit from:
- Global exposure in Pharmacovigilance operations
- Career growth in drug safety and quality
- Regulatory and compliance learning opportunities
- Collaborative work culture
- Experience with international clients and inspections
How to Apply
