Job Title: Senior Project Lead – Pharmacovigilance / Patient Safety (PSS)
Company: Fortrea
Location: Bangalore, India
Department: Clinical Safety / Pharmacovigilance
Job Type: Full-Time
Experience Required: 3–8 Years of Experience in Pharmacovigilance, Drug Safety, or Clinical Safety Operations (depending on educational qualification)
About Fortrea
Fortrea is a leading global contract research organization (CRO) that provides clinical development and patient safety solutions to pharmaceutical, biotechnology, and medical device companies. With a strong presence across global markets, Fortrea supports clinical trials, regulatory compliance, and pharmacovigilance operations to ensure patient safety and regulatory integrity.
The organization is committed to delivering high-quality scientific expertise and operational excellence in drug development and safety monitoring.
Role Overview
The Senior Project Lead – Patient Safety Services (PSS) will oversee pharmacovigilance activities related to clinical safety and adverse event management across assigned projects. The role is responsible for ensuring accurate processing and regulatory reporting of safety data from clinical trials and post-marketing sources.
This position requires strong expertise in pharmacovigilance operations, safety database management, regulatory reporting, and cross-functional collaboration to ensure compliance with global pharmacovigilance guidelines and regulatory standards.
Key Responsibilities
Adverse Event Management and Safety Case Processing
Oversee the receipt, review, and processing of adverse event (AE) and serious adverse event (SAE) reports from clinical trials and post-marketing sources.
Ensure safety case documentation meets regulatory standards and internal pharmacovigilance procedures.
Regulatory Safety Reporting
Ensure expedited adverse event reporting to regulatory authorities and clients within defined timelines.
Maintain compliance with international pharmacovigilance regulations and safety reporting requirements.
Safety Database Management
Maintain a strong understanding of Fortrea’s safety database conventions and client-specific safety systems.
Ensure proper data entry, validation, and management of safety information within pharmacovigilance databases.
Pharmacovigilance Report Preparation
Support preparation and submission of key pharmacovigilance reports including:
Individual Case Safety Reports (ICSRs)
Serious Adverse Event (SAE) narratives
Development Safety Update Reports (DSUR)
Periodic Safety Reports (PSRs)
Annual IND safety reports
Aggregate safety reports and line listings.
Global Project Safety Leadership
Act as safety lead for assigned regional or global projects to ensure consistent safety operations and reporting standards.
Facilitate communication and alignment across internal teams and external partners.
Safety Data Reconciliation
Collaborate with internal teams and external partners to reconcile safety databases and ensure accurate data tracking.
Workflow Monitoring and Project Oversight
Monitor project workflows to ensure safety deliverables meet timelines and quality standards.
Support project planning and operational management for pharmacovigilance programs.
Safety Documentation and SOP Compliance
Maintain thorough knowledge of departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and safety reporting guidelines.
Contribute to the development and improvement of safety procedures and documentation.
Safety Management Plan Development
Assist in preparing Safety Management Plans (SMPs), reconciliation plans, and study-specific safety documentation.
Training and Knowledge Sharing
Develop training materials, study job aids, and operational templates to support pharmacovigilance processes.
Deliver safety presentations to internal teams and external stakeholders when required.
Clinical Trial Support and System Setup
Support safety system setup during study start-up and maintain operational processes throughout the study lifecycle.
Audit and Compliance Support
Participate in internal, client, and regulatory audits and assist in audit preparation activities.
Provide pharmacovigilance data and reports for Safety Committees and Data Safety Monitoring Boards (DSMBs).
Project Coordination and Client Interaction
Participate in project team meetings and maintain communication with internal stakeholders and external clients.
Support project financial management and identify out-of-scope activities when necessary.
Trial Master File (TMF) Support
Assist with TMF management and ensure safety documentation is properly maintained and audit-ready.
Educational Qualifications
Bachelor’s Degree (BS/BA) in Life Sciences, Pharmacy, Biological Sciences, Chemistry, or Nursing with at least 3 years of safety experience.
Master’s Degree (MS/MA) in Life Sciences or related discipline with 2–3 years of safety experience.
PharmD with at least 1 year of safety experience or 2 years of relevant pharmaceutical industry experience.
Associate Degree with 3–4 years of safety experience may also be considered.
Equivalent industry experience in pharmaceutical, biotechnology, or CRO environments may substitute formal education requirements.
Experience Requirements
Experience in pharmacovigilance operations including processing AE/SAE reports.
Hands-on experience working with pharmacovigilance safety databases.
Experience generating safety narratives, queries, and regulatory reports.
Familiarity with clinical safety documentation and regulatory submission requirements.
Key Skills
Pharmacovigilance and Drug Safety Expertise
Strong knowledge of adverse event processing and safety case management.
Regulatory Compliance Knowledge
Understanding of global pharmacovigilance regulations and reporting requirements.
Clinical Research and Safety Standards
Knowledge of Good Clinical Practice (GCP) guidelines and ICH safety standards.
Safety Data Management
Experience with pharmacovigilance databases and clinical safety documentation.
Analytical and Problem-Solving Skills
Ability to identify safety issues and support corrective actions.
Communication and Collaboration
Strong verbal, written, and presentation skills for internal and client communication.
Technical Proficiency
Proficiency in Microsoft Office tools and documentation systems used in clinical research.
Language Requirements
Strong English communication skills (speaking, writing, and reading).
Knowledge of additional local languages may be beneficial.
Work Environment
Office-based role within a clinical research and pharmacovigilance environment.
Travel Requirements
Up to 10% travel may be required depending on project needs, including occasional overnight stays.
Equal Opportunity Employer
Fortrea is committed to fostering an inclusive and diverse workplace environment and provides equal employment opportunities to all qualified applicants regardless of background or identity.
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