Senior Project Lead, PSS Pharmacovigilance Job
Looking to step into a leadership Pharma Job role in pharmacovigilance and clinical safety? The Senior Project Lead – PSS position at Fortrea offers an exciting opportunity to manage global safety projects, lead adverse event reporting, and work closely with regulatory agencies. This role is ideal for experienced safety professionals aiming to grow into strategic and client-facing responsibilities. Graduates seeking PharmD Jobs or Pharmacy jobs can apply now.
- Job Role: Senior Project Lead – PSS
- Location: Bangalore
About the Company
Fortrea is a leading global contract research organization (CRO) specializing in clinical development, patient access, and safety solutions. The company partners with pharmaceutical, biotechnology, and medical device organizations to deliver innovative and compliant clinical research services worldwide. This Pharma Job role plays a significant role in the company.
Educational Requirements
Fortrea considers a combination of education and safety experience:
- PharmD: 1 year safety experience or 2 years relevant experience
- Preferred Fields: Pharmacy
(PharmD fellowship or residency is considered relevant experience)
Key Responsibilities
- Oversee receipt and processing of AE/SAE reports from clinical trials and post-marketing sources
- Ensure compliance with ICH, GCP, US and global regulatory requirements
- Manage expedited adverse event reporting within defined timelines
- Prepare and review ICSRs, DSURs, PSURs, IND reports, and line listings
- Act as Safety Lead for assigned global or regional projects
- Coordinate safety database reconciliation with internal and external teams
- Support study start-up, system set-up, and ongoing maintenance
- Develop and update Safety Management Plans (SMPs) and reconciliation plans
- Participate in client meetings, audits, DSMB support, and safety committee data preparation
- Support project financial tracking and identify out-of-scope work
- Assist in SOP, WI, job aid, and training material development
Skills Required
- Strong knowledge of pharmacovigilance operations
- Expertise in AE/SAE processing and safety databases
- Understanding of ICH guidelines and GCP
- Excellent communication, presentation, and organizational skills
- High attention to detail and data accuracy
- Ability to lead cross-functional and global teams
- Proficiency in MS Office tools
- Knowledge of medical terminology and regulatory reporting
- Medical device safety knowledge (desirable)
- Graduates seeking PharmD Jobs or Pharmacy jobs can apply now.
