Pharmacovigilance Job at Fortrea | PharmD Graduates Eligible
Looking for a Pharmacovigilance Job with a globally recognized CRO? Fortrea Careers has announced an exciting opportunity for the Project Manager – Drug Safety position in Bangalore. This role is ideal for experienced PharmD professionals seeking to advance their career in pharmacovigilance, drug safety, adverse event reporting, and global regulatory compliance. Explore this excellent opportunity and apply through Fortrea Careers today.
- Job Title: Project Manager Drug Safety
- Locations: Bangalore
- Job Requisition ID: 263786
About the Company
Fortrea is a leading global Contract Research Organization (CRO) providing clinical development, pharmacovigilance, regulatory, and drug safety solutions to pharmaceutical, biotechnology, and medical device companies worldwide. Through Fortrea Careers, professionals can work on global projects that contribute to patient safety and regulatory excellence.
Job Description
This Pharmacovigilance Job at Fortrea Careers involves managing global drug safety projects, overseeing adverse event processing, ensuring regulatory compliance, coordinating expedited safety reporting, preparing safety documentation, and leading pharmacovigilance operations for clinical trials and post-marketing activities.
Key Responsibilities
- Lead global and regional pharmacovigilance projects.
- Manage adverse event (AE) and serious adverse event (SAE) processing.
- Review Individual Case Safety Reports (ICSRs).
- Ensure timely expedited safety reporting.
- Review MedDRA coding and patient narratives.
- Coordinate with clinical operations and regulators
Qualifications
Eligible Qualification
- PharmD with 1–2 years of Drug Safety experience, or
- PharmD with 2–3 years of relevant pharmaceutical, biotechnology, or CRO experience.
- PharmD residency or fellowship may be considered relevant experience.
Preferred knowledge includes
- Pharmacovigilance
- Drug Safety
- Adverse Event Reporting
- MedDRA
- ICSR Processing
- ICH Guidelines
- Good Clinical Practice (GCP)
- Regulatory Reporting
- Safety Databases
- EudraVigilance
Why Join This Role?
- Work with a Global CRO: Build your career with Fortrea, a globally recognized Contract Research Organization serving leading pharmaceutical and biotechnology companies.
- Lead Global Pharmacovigilance Projects: Manage international drug safety programs and contribute to patient safety on a global scale.
- Career Growth in Drug Safety: Strengthen your expertise in pharmacovigilance, adverse event management, regulatory reporting, and project leadership.
- Exposure to Global Regulations: Gain hands-on experience with ICH guidelines, Good Clinical Practice (GCP), MedDRA, EudraVigilance, and worldwide pharmacovigilance requirements.
- Develop Leadership Skills: Mentor team members, manage project workflows, and collaborate with cross-functional global teams.
