Fortrea, a global leader in pharmaceutical services, is hiring for 7 key positions across Pune and Mumbai, offering careers in Clinical Safety, Quality Assurance, Regulatory Operations, and Medical Science. These full-time roles cater to professionals in pharmacovigilance, regulatory affairs, medical writing, and safety analysis, blending scientific expertise with regulatory compliance. Whether you are starting your pharma career or seeking senior roles, Fortrea’s opportunities offer growth and exposure to global healthcare projects.
Available Positions at Fortrea
- Safety Science Coordinator I (Pune)
Coordinate and process clinical and post-marketing adverse event reports. Manage safety data entry, case narratives, regulatory submissions, and client communications. Ideal for candidates with 0-2 years safety experience in pharma or CRO. - Functional Quality Associate II (Pune, Hybrid)
Perform quality reviews of safety reports and support corrective actions. Assist in audit preparations and ensure compliance with pharmacovigilance guidelines. Requires 2+ years pharma/CRO experience in quality or safety. - Regulatory Operations Specialist II (Mumbai)
Oversee analytical support for drug development projects, liaise with contract labs, and ensure compliance with GMP and regulatory standards. 4-6 years’ experience in regulatory affairs or pharmaceutical development preferred. - Safety Analysis Scientist (Mumbai/Manila)
Lead safety report preparation, signal detection, and risk analysis. Manage medical writing teams and client deliverables. Requires 5-7 years pharma industry experience and medical writing expertise. - Medical Physician Specialist II (Mumbai)
Provide expert medical safety review and case assessments for pharmacovigilance within post-marketing drug surveillance. An MD or equivalent with clinical experience preferred. - Regulatory Operations Expert (Mumbai)
Manage regulatory documentation lifecycle and quality assurance in pharmaceutical labs. Requires 3-5 years experience and strong GMP knowledge. - Functional Quality Specialist I (Pune, Hybrid)
Support quality review of clinical safety cases and adverse event processing. Assist audits and quality improvement initiatives. Suitable for candidates with 2+ years in pharmacovigilance/safety writing.
Key Responsibilities Across Roles
- Processing, reviewing, and submitting adverse event reports (AE/SAE)
- Conducting quality reviews and audits in pharmacovigilance
- Preparing regulatory documents and safety reports (PSURs, PADERs, RMPs)
- Managing client communications and serving as a quality service liaison
- Coordinating safety database maintenance and case tracking
- Supporting regulatory inspections and documentation compliance
- Leading scientific writing and medical safety evaluations
- Facilitating training, mentoring, and process improvement initiatives
Minimum Qualifications
- Education ranging from Associate Degree to PhD in Pharmacy, Biological Sciences, Life Sciences, Medicine, or related fields
- Relevant pharmaceutical, biotechnology, or CRO experience from 0-7 years depending on the role
- Familiarity with regulatory requirements such as ICH, GCP, GVP, FDA, and EU directives
- Proficiency in English communication and MS Office tools
- Ability to work collaboratively in team-oriented, fast-paced environments
Benefits of Joining Fortrea
- Exposure to global pharmaceutical projects across clinical and post-marketing safety
- Hybrid and remote work opportunities with flexible office locations in Pune and Mumbai
- Professional growth with mentorship and leadership development
- Involvement in diverse regulatory and safety disciplines
- Competitive salary packages aligned with industry standards
- Supportive work culture focusing on compliance and quality excellence
How to Apply
Application Link for Safety Science Coordinator I (Pune)
Application Link for Functional Quality Associate II
Application Link for Regulatory Operations Specialist II
Application Link for Safety Analysis Scientist
Application Link for Medical Physician Specialist II
Application Link for Regulatory Operations Expert
Application Link for Functional Quality Specialist IÂ
