Senior Project Lead – Pharmacovigilance & Patient Safety Services (PSS)
Location: Bangalore, India
Category: Clinical / Pharmacovigilance
Job ID: 26403
Employment Type: Full-Time
Experience Required: 3–5+ Years (Depending on Qualification)
About the Company
Fortrea is a global contract research organization (CRO) delivering clinical development and post-marketing safety solutions to pharmaceutical, biotechnology, and medical device companies worldwide.
Role Overview
The Senior Project Lead – Patient Safety Services (PSS) is responsible for overseeing clinical safety operations across assigned projects. This includes managing adverse event (AE) and serious adverse event (SAE) reporting from clinical trials and post-marketing sources, ensuring compliance with global regulatory standards and client requirements.
Key Responsibilities
Clinical Safety Oversight
Oversee receipt, processing, and evaluation of adverse event reports from spontaneous and clinical trial sources
Ensure expedited safety reporting to regulatory authorities and clients within defined timelines
Maintain compliance with international pharmacovigilance regulations, SOPs, and safety guidelines
Support safety database reconciliation activities
Regulatory & Aggregate Reporting
Prepare and review:
Individual Case Safety Reports (ICSRs)
Serious Adverse Event (SAE) reports
Annual IND Reports
Development Safety Update Reports (DSURs)
Periodic Safety Reports (PSRs)
Line listings and aggregate safety reports
Ensure compliance with ICH Guidelines and Good Clinical Practice (GCP) requirements
Provide safety data support to Safety Committees and DSMBs
Project Leadership & Client Management
Act as Global or Regional Safety Lead for assigned projects
Monitor workflow and ensure adherence to project milestones
Participate in client meetings and cross-functional discussions
Deliver safety presentations to internal and external stakeholders
Assist with project financial oversight and scope management
Process & Compliance Management
Contribute to the development and revision of SOPs and Work Instructions
Support preparation of Safety Management Plans (SMPs) and Reconciliation Plans
Assist with Trial Master File (TMF) activities
Participate in internal, client, and regulatory audits
Educational Qualification & Experience Requirements
Experience requirements vary by academic background:
Non-degree: Minimum 5 years of pharmacovigilance/safety experience
Associate’s Degree: 3–4 years safety experience
Bachelor’s Degree (BS/BA): 3 years safety experience
Master’s Degree (MS/MA): 2–3 years safety experience
PharmD: 1 year safety experience or 2 years relevant industry experience
One-year residency or fellowship may be considered relevant experience
Safety experience must include hands-on AE/SAE case processing, narrative writing, query handling, safety database usage, and regulatory submissions.
Required Skills & Competencies
Strong knowledge of medical and drug terminology
In-depth understanding of ICH Guidelines and GCP
Knowledge of global regulatory requirements for investigational product safety reporting
Strong communication and presentation skills
High attention to detail and accuracy
Ability to anticipate project risks and implement corrective measures
Proficiency in MS Office tools
Preferred Educational Background
Degrees in:
Biological Sciences
Pharmacy
Nursing
Life Sciences
Chemistry
Work Environment & Travel
Office-based role in Bangalore
Up to 10% travel, including occasional overnight stays based on project needs
SEO Keywords:
Senior Project Lead Pharmacovigilance Bangalore, Patient Safety Services jobs India, Clinical Safety Lead vacancy, Drug Safety Project Manager Bangalore, ICSR reporting careers, DSUR PSUR pharmacovigilance jobs, CRO safety leadership roles.
Explore more pharmacovigilance and clinical research career opportunities at ThePharmaDaily.com.
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