Job Summary
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.
Responsibilities
- Manage end to end pharmacovigilance operations for assigned clients by 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.
Qualifications
- 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 even if not as a primary responsibility.
- Hold a graduate or postgraduate degree in pharmacy life sciences medicine or a related discipline that provides 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.
- Utilize proficiency with common safety databases and office productivity tools by entering reviewing and tracking case data as well as preparing reports and presentations.
- 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.
Certifications Required
Preferred certifications include pharmacovigilance certification from DIA or equivalent and advanced training in clinical research or drug safety.
Over Cognizant
Cognizant (NASDAQ: CTSH) is een bouwer van AI-oplossingen en een leverancier van technologiediensten. Wij slaan de brug tussen AI-investeringen en ondernemingswaarde door het bouwen van full-stack AI-oplossingen voor onze klanten. Onze diepgaande kennis van sectoren, processen en engineering stelt ons in staat om de unieke context van een organisatie te verankeren in technologische systemen. Deze systemen versterken het menselijk potentieel, realiseren tastbare resultaten en geven wereldwijde ondernemingen een voorsprong in een snel veranderende wereld. Ontdek hoe op cognizant.ai of @cognizant.
Aanvullende arbeidsinformatie
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