Job Summary
Contribute to medical safety activities within a global pharmaceutical environment by supporting end to end safety case review and documentation for clinical and post marketing products. Apply knowledge of pharma research and development and pharmacovigilance operations to ensure robust assessment of individual case safety reports while collaborating in a hybrid work model to uphold patient safety and regulatory compliance across diverse therapeutic areas.
Responsibilities
Perform systematic medical safety review of individual case safety reports to ensure accurate assessment of seriousness causality and clinical relevance in alignment with internal standards and global regulatory expectations.Apply foundational knowledge of pharma research and development to interpret clinical trial data product labels and risk benefit profiles when evaluating reported adverse events and safety signals.Execute end to end case processing activities including medical evaluation narrative refinement coding verification and consistency checks to maintain high quality safety data within applicable systems.Conduct thorough verification of source documents and supporting clinical information to confirm case validity completeness and coherence while escalating unclear or conflicting data for clarification.Participate in routine safety review meetings by providing concise case level insights that support aggregate safety assessments risk mitigation strategies and regulatory submissions.Adhere strictly to established pharmacovigilance workflows and standard operating procedures to ensure timely case processing within agreed service levels and compliance with global health authority requirements.Collaborate with cross functional pharmacovigilance and safety operations teams to clarify medical details resolve data discrepancies and support continuous improvement of safety review practices.Maintain meticulous documentation of case handling decisions rationale and follow up actions to enable transparent audit trails and facilitate inspections or internal quality reviews.Utilize safety databases and relevant tools to retrieve analyze and update case information while ensuring accurate coding and classification of events products and medical history.Contribute to signal detection and risk evaluation activities by highlighting unusual patterns medically significant events or emerging trends observed during case review activities.Support hybrid work model expectations by coordinating effectively through digital collaboration platforms and maintaining consistent communication with team members during day shift operations.Advance patient safety outcomes by ensuring that each processed case supports reliable safety profiles which inform healthcare professionals regulators and internal stakeholders.Engage in continuous learning related to evolving pharmacovigilance regulations medical safety methodologies and product specific knowledge to strengthen the quality of case evaluations.
Qualifications
Possess academic background in life sciences pharmacy medicine or a related discipline that enables sound understanding of clinical concepts and therapeutic areas relevant to medical safety.Demonstrate practical experience or training in pharmacovigilance and safety operations with direct exposure to case processing workflows and medical review principles even at an entry level.Show applied familiarity with pharma research and development processes including clinical trial phases key endpoints and safety data collection practices that support robust case evaluation.Exhibit capability to perform medical safety review for individual case safety reports using structured assessment techniques and clear documentation of clinical reasoning.Communicate effectively in English through clear written narratives and spoken interactions to present case findings collaborate with stakeholders and support regulatory compliant documentation.Display strong attention to detail analytical thinking and accountability in managing safety data ensuring consistency accuracy and reliability across all handled cases.Adapt to hybrid work arrangements and day shift schedules while using collaboration tools productivity applications and safety systems to maintain seamless case processing and team coordination.
Certifications Required
Preferred certification in pharmacovigilance or drug safety such as professional training in Good Pharmacovigilance Practices or equivalent industry recognized programs.
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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