Job Summary
Serve as a subject matter expert in medical safety within a global pharmaceutical environment applying research and development knowledge to support safe and effective product development. Contribute to risk assessment safety data interpretation and medical review activities in a hybrid work model ensuring day shift engagement and strong collaboration across cross functional teams.
Responsibilities
- Apply medical safety expertise to interpret clinical and nonclinical data from pharma research and development activities ensuring that emerging safety signals are identified and documented with clarity and consistency across assigned products.
- Perform structured medical safety assessments of individual and aggregate case data from clinical trials and postmarketing sources focusing on accurate evaluation of seriousness causality and potential impact on patient safety and regulatory commitments.
- Collaborate with cross functional teams in research and development to provide timely medical safety input on study protocols informed consent documents and safety monitoring plans supporting robust risk mitigation strategies for ongoing projects.
- Review and refine safety related sections of core clinical and regulatory documents including risk management narratives and summary reports ensuring that medical interpretations are scientifically sound and aligned with company safety standards.
- Support signal detection activities by analyzing safety trends preparing concise summaries of safety data and recommending follow up actions that promote continuous improvement in product safety profiles.
- Coordinate with pharmacovigilance and clinical operations partners to clarify case details resolve data inconsistencies and enhance the overall quality and completeness of safety information captured in internal systems.
- Contribute to the preparation of responses for safety related queries from regulatory authorities and internal stakeholders ensuring that explanations are medically justified data driven and aligned with global safety practices.
- Maintain accurate documentation of medical safety decisions rationales and review outcomes in designated tools supporting audit readiness and transparent traceability of safety evaluations across the product lifecycle.
- Participate in cross functional meetings during the day shift to discuss safety topics share insights from ongoing reviews and ensure that safety considerations are integrated into key development and commercialization decisions.
- Support development and refinement of internal medical safety procedures by providing feedback from practical case handling experience helping to streamline workflows and enhance overall efficiency in safety review activities.
- Engage in hybrid work model collaboration using digital communication tools maintaining strong partnerships with global colleagues while ensuring timely delivery of safety assessments and documentation.
- Contribute to the company purpose of bringing safe and effective therapies to individuals and communities by rigorously applying medical judgment to safety data and highlighting potential risks that may affect public health outcomes.
- Pursue continuous learning in medical safety research and development practices and evolving pharmacovigilance requirements to keep safety evaluations current and to support innovative solutions that improve societal health.
Qualifications
- Demonstrate solid experience in pharma research and development with two to three years of hands on involvement in safety related aspects of clinical studies or product development activities.
- Apply practical understanding of adverse event evaluation seriousness assessment and causality reasoning gained from previous roles in medical safety or closely related research functions.
- Utilize working knowledge of pharmacovigilance processes and medical review practices including exposure to PV medical review activities to support high quality case assessments and signal evaluations.
- Employ strong analytical and critical thinking capabilities to interpret complex medical data sets summarize key safety insights and communicate findings clearly to nonmedical colleagues.
- Use effective written and verbal communication skills to prepare structured safety summaries medical narratives and responses for internal and external stakeholders in a concise and comprehensible manner.
- Operate comfortably in a hybrid work environment and day shift setting managing time and tasks independently while staying fully engaged with remote and onsite team interactions.
- Draw on experience with standard safety and clinical data systems such as electronic data capture tools or safety databases to retrieve information verify case details and support accurate documentation.
- Exhibit commitment to ethical medical practice and patient safety by following internal procedures regulatory expectations and scientific principles in every aspect of safety review and documentation.
Certifications Required
Preferred certification in pharmacovigilance or drug safety such as Pharmacovigilance Professional Certification or equivalent.
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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