Join Fortrea: Opportunities in Clinical Safety, Quality, Regulatory, and Medical Science
Fortrea, a leading global provider of pharmaceutical services, is seeking talented professionals to join our growing team in Pune and Mumbai. We have several full-time positions available across Clinical Safety, Quality Assurance, Regulatory Operations, and Medical Science. These roles offer exciting opportunities for individuals with expertise in pharmacovigilance, regulatory affairs, medical writing, and safety analysis. If you’re passionate about contributing to global healthcare and seeking a career with growth potential, we encourage you to apply.
Job Summary:
Fortrea is hiring for multiple positions in Pune and Mumbai within our Clinical Safety, Quality Assurance, Regulatory Operations, and Medical Science departments. These roles range from entry-level to experienced professional and offer the chance to work on diverse global pharmaceutical projects. We are looking for individuals with a strong understanding of regulatory guidelines, a commitment to quality, and a desire to make a difference in the healthcare industry.
Responsibilities:
Responsibilities vary depending on the specific role, but generally include:
- 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.
Available Positions:
- 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.
- 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.
- Regulatory Operations Specialist II (Mumbai): Oversee analytical support for drug development projects, liaise with contract labs, and ensure compliance with GMP and regulatory standards.
- Safety Analysis Scientist (Mumbai/Manila): Lead safety report preparation, signal detection, and risk analysis. Manage medical writing teams and client deliverables.
- Medical Physician Specialist II (Mumbai): Provide expert medical safety review and case assessments for pharmacovigilance within post-marketing drug surveillance.
- Regulatory Operations Expert (Mumbai): Manage regulatory documentation lifecycle and quality assurance in pharmaceutical labs.
- Functional Quality Specialist I (Pune, Hybrid): Support quality review of clinical safety cases and adverse event processing. Assist audits and quality improvement initiatives.
Requirements:
- Education: Associate Degree to PhD in Pharmacy, Biological Sciences, Life Sciences, Medicine, or related fields.
- Experience: Relevant pharmaceutical, biotechnology, or CRO experience, ranging from 0 to 7 years depending on the role.
- Knowledge: Familiarity with regulatory requirements such as ICH, GCP, GVP, FDA, and EU directives.
- Skills:
- Proficiency in English communication (written and verbal).
- Proficiency in 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 (for certain roles) with flexible office locations in Pune and Mumbai.
- Professional growth with mentorship and leadership development programs.
- 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:
Interested candidates are encouraged to apply for the specific positions they are qualified for through the following links:
- [Application Link for Safety Science Coordinator I (Pune)](Insert Application Link Here)
- [Application Link for Functional Quality Associate II (Pune, Hybrid)](Insert Application Link Here)
- [Application Link for Regulatory Operations Specialist II (Mumbai)](Insert Application Link Here)
- [Application Link for Safety Analysis Scientist (Mumbai/Manila)](Insert Application Link Here)
- [Application Link for Medical Physician Specialist II (Mumbai)](Insert Application Link Here)
- [Application Link for Regulatory Operations Expert (Mumbai)](Insert Application Link Here)
- [Application Link for Functional Quality Specialist I (Pune, Hybrid)](Insert Application Link Here)
We look forward to receiving your application!