Job Title: Senior Project Lead – Pharmacovigilance & Patient Safety Services (PSS)
Location: Bangalore, India
Job Type: Full-Time
Job ID: 26403
Posted: 2 Days Ago
Job Category: Pharmacovigilance / Drug Safety / Clinical Safety / Regulatory Affairs
Job Overview
We are hiring an experienced Senior Project Lead – PSS (Pharmacovigilance & Patient Safety Services) to oversee clinical safety operations and adverse event management activities. This leadership role is responsible for managing end-to-end pharmacovigilance processes, including safety data from clinical trials and post-marketing sources, while ensuring regulatory compliance and high-quality client service delivery.
The selected candidate will act as a global or regional safety lead, ensuring accurate and timely expedited adverse event reporting to clients and regulatory authorities in accordance with international regulations and internal SOPs.
Experience Required
Candidates must meet one of the following minimum experience criteria:
Non-degree qualification with 5+ years of safety experience
Associate’s degree with 3–4 years of safety experience
Bachelor’s degree (BS/BA) with 3+ years of safety experience
Master’s degree (MS/MA) with 2–3 years of safety experience or 2 years of relevant industry experience
PharmD with 1+ year of safety experience or 2 years of relevant experience
A one-year PharmD residency or fellowship may be considered relevant experience
Safety experience must include operational handling of AE/SAE cases, narrative writing, query management, safety database usage, and regulatory submissions.
Key Responsibilities
Oversee receipt, processing, and management of adverse event (AE) and serious adverse event (SAE) reports from clinical trials and spontaneous sources
Ensure compliant expedited safety reporting in accordance with US and global regulatory requirements, ICH guidelines, and internal SOPs
Act as safety lead for assigned global or regional projects, ensuring harmonized processes and effective communication
Prepare and support pharmacovigilance documentation including:
Individual Case Safety Reports (ICSRs)
Annual IND reports
Development Safety Update Reports (DSURs)
Periodic Safety Reports (PSRs)
Line listings and aggregate safety reports
Support safety database reconciliation activities with internal and external partners
Monitor project workflows to ensure regulatory timelines are consistently met
Develop and deliver safety presentations to internal stakeholders, clients, and regulatory bodies
Contribute to development and revision of Work Instructions (WIs) and Standard Operating Procedures (SOPs)
Support preparation of Safety Management Plans (SMPs), reconciliation plans, and study-specific safety documentation
Participate in audits (internal, client, regulatory) and ensure audit readiness
Assist with Safety Committee and DSMB data preparation
Support TMF management and project financial oversight, including identification of out-of-scope activities
Maintain cross-functional collaboration across departments
Required Skills & Competencies
Strong knowledge of pharmacovigilance processes and global adverse event reporting requirements
Operational experience with safety databases and regulatory submissions
In-depth understanding of Good Clinical Practice (GCP) and ICH Guidelines
Knowledge of worldwide investigational product safety reporting requirements
Familiarity with medical and drug terminology
Strong proficiency in MS Office tools
Excellent verbal, written, and presentation skills
High attention to detail and accuracy
Strong organizational and problem-solving skills
Ability to anticipate risks and proactively escalate issues
Strong teamwork and cross-functional collaboration capabilities
Preferred Qualifications
Degree in Biological Sciences, Pharmacy, Nursing, Life Sciences, or Chemistry
Knowledge of Medical Device safety reporting
Understanding of R&D processes within pharmaceutical, biotechnology, or CRO environments
Experience in related areas such as Medical Affairs, Clinical Data Management, Regulatory Affairs, Project Management, or Quality Assurance
Work Environment
Office-based role in Bangalore, India
Travel requirement: Up to 10%, including occasional overnight travel based on project needs
Why Apply?
This is a strategic pharmacovigilance leadership opportunity for professionals seeking to advance their career in global clinical safety operations. The role offers exposure to international regulatory frameworks, cross-functional leadership, and end-to-end safety project management within the pharmaceutical and CRO industry.
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