TM-Pharmacovigilance

About the Role

This role focuses on pharmacovigilance delivery for global pharmaceutical clients by managing end-to-end safety operations in a hybrid work model while using deep pharma research and development expertise. The professional will ensure compliant safety data handling, process optimization, quality oversight, and continuous improvement across case processing and allied safety workflows, supporting safer therapies for patients worldwide.

Key Responsibilities

• Manage end-to-end pharmacovigilance operations for assigned clients, overseeing case intake, evaluation, documentation, and closure while ensuring regulatory compliant timelines are consistently met.
• Coordinate cross-functional collaboration between pharma research and development teams and safety operations teams to ensure consistent interpretation and integration of safety data across clinical and post-marketing activities.
• Drive continuous improvement initiatives across pharmacovigilance workflows by identifying process gaps, proposing pragmatic enhancements, and supporting implementation to improve quality and operational efficiency.
• Monitor key performance indicators and quality metrics for pharmacovigilance activities by preparing regular reports and using insights to recommend corrective and preventive actions.
• Guide teams in applying pharma research and development knowledge to safety cases by ensuring that clinical context, study design details, and investigational product information are accurately reflected in safety documentation.
• Review complex safety cases and narratives by validating medical and scientific accuracy, consistency with source data, and alignment with applicable regulations and internal procedures.
• Collaborate with medical reviewers, safety physicians, and data management partners by supporting thorough assessment of case seriousness, expectedness, and benefit-risk implications.
• Support audit and inspection readiness activities by maintaining documentation discipline, responding to queries, and promoting adherence to standard operating procedures and work instructions.
• Coordinate with technology and data teams to optimize case processing tools by providing functional feedback, testing enhancements, and promoting user adoption in day-to-day operations.
• Ensure strong stakeholder communication by providing clear status updates, discussing risk areas proactively, and aligning expectations regarding deliverables and timelines.
• Train and mentor junior pharmacovigilance professionals by sharing domain knowledge, explaining pharma research and development concepts, and reinforcing best practices in safety data handling.
• Apply knowledge of global regulatory frameworks for pharmacovigilance by ensuring that all safety deliverables meet the requirements of major health authorities and client-specific standards.
• Support organizational purpose by contributing to safer medicines for patients through accurate, timely, and reliable safety data processing, and promoting a culture of quality and accountability.

Requirements & Tech Stack

• Possess substantial experience in pharma research and development by applying clinical and scientific understanding to interpret study data, investigational products, and patient safety information in routine activities.
• Demonstrate proven exposure to pharmacovigilance case processing by handling or reviewing safety cases, narratives, and follow-up activities.
• Utilize proficiency with common safety databases and office productivity tools.
• Adapt effectively to a hybrid work model by managing time independently, maintaining productivity, and ensuring secure handling of sensitive safety and clinical information.
• Maintain up-to-date understanding of emerging pharmacovigilance trends, regulatory expectations, and industry practices by engaging in continuous learning and applying new knowledge in daily work.

Qualifications

• Hold a graduate or postgraduate degree in pharmacy, life sciences, medicine, or a related discipline that provides a sound understanding of drug development and human biology.
• Apply strong analytical and problem-solving skills by evaluating complex case information, identifying inconsistencies, and proposing practical resolutions within established timelines.
• Communicate clearly in written and spoken form by preparing structured safety documentation, concise emails, and collaborative discussions with global stakeholders.

Certifications

• Required Preferred certifications include pharmacovigilance certification from DIA or equivalent and advanced training in clinical research or drug safety.