Job Summary
This hybrid role is for a specialist professional in pharmacovigilance with experience in pharma research and development focused on ensuring high quality safety data and regulatory compliance for global markets. The role involves daily case review safety data analysis and collaboration with cross functional teams to support safer therapies for patients worldwide.
Responsibilities
- Perform pharmacovigilance case intake activities by reviewing source documents verifying completeness of safety information and ensuring accurate capture of relevant medical data to maintain high quality case processing standards.
- Execute detailed case assessment activities by evaluating seriousness causality and expectedness based on clinical and scientific judgment to support consistent safety signal interpretation.
- Document adverse events and product complaints in safety databases by entering structured and narrative information with strong attention to accuracy and consistency to comply with internal and regulatory requirements.
- Collaborate with cross functional colleagues in clinical development medical affairs and regulatory functions by sharing safety insights to support informed benefit risk evaluations for investigational and marketed products.
- Apply pharma research and development knowledge by interpreting clinical protocols investigator brochures and development safety update reports to ensure case evaluation aligns with project objectives.
- Conduct ongoing case follow up by tracking pending information coordinating with partners and updating records to maintain complete and reliable pharmacovigilance data sets.
- Review safety data outputs such as line listings and summary tables by identifying inconsistencies and trends to support aggregate safety reporting and risk management activities.
- Support process improvement initiatives by identifying recurring issues in data entry documentation and case routing to enhance overall efficiency and quality of pharmacovigilance operations.
- Ensure strict adherence to global regulations and internal standard operating procedures by staying current with evolving pharmacovigilance guidance and applying it consistently during daily tasks.
- Utilize pharmacovigilance systems and tools by performing data entry query resolution and quality checks to maintain data integrity and traceability across the safety lifecycle.
- Coordinate with vendor or partner teams where applicable by clarifying case requirements sharing feedback and supporting smooth handoffs to achieve timely and compliant case closure.
- Participate in audits and inspections by providing clear documentation case histories and process explanations to demonstrate robust compliance and quality controls.
- Contribute to a culture of patient safety by highlighting potential safety concerns promoting responsible data practices and supporting improved health outcomes for individuals and communities.
Qualifications
- Possess a degree in pharmacy life sciences medicine or a related scientific discipline with practical experience in pharma research and development supporting clinical or safety activities.
- Demonstrate two to four years of hands on pharmacovigilance or drug safety experience with proven exposure to case processing workflows and safety database usage.
- Exhibit working knowledge of pharmacovigilance data management practices by understanding coding conventions dictionary usage and principles of structured medical data capture.
- Show familiarity with PV case processing steps including intake triage data entry medical review support and case closure while maintaining timelines and quality requirements.
- Display strong understanding of regulatory expectations for safety reporting including key concepts related to seriousness expectedness and causality assessment.
- Utilize effective communication skills to collaborate with global teams clarify medical details and document case summaries in a clear and concise manner.
- Apply strong analytical and problem solving skills to investigate discrepancies resolve data issues and contribute to process enhancements in pharmacovigilance operations.
- Maintain high attention to detail and quality focus by consistently following standard operating procedures work instructions and documentation practices.
- Leverage working knowledge of hybrid work environments by effectively managing time virtual collaboration tools and secure handling of safety information while working from different locations.
Certifications Required
Preferred certifications include pharmacovigilance or drug safety credentials such as a pharmacovigilance certification from a recognized life science institute.
Über Cognizant
Cognizant (NASDAQ: CTSH) i ist ein Technologiedienstleister und Entwickler von KI-Lösungen. Wir schlagen die Brücke zwischen KI-Investitionen und echtem unternehmerischem Mehrwert, indem wir ganzheitliche Full-Stack-KI-Lösungen für unsere Kunden entwickeln. Mit unserer fundierten Branchen-, Prozess- und Engineering-Expertise integrieren wir die spezifischen Anforderungen von Unternehmen passgenau in Technologiesysteme. So entfalten wir das menschliche Potenzial, erzielen greifbare Ergebnisse und sichern globalen Unternehmen in einer sich rasant wandelnden Welt den entscheidenden Vorsprung. Erfahren Sie mehr unter cognizant.ai oder @cognizant.
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