Job SummaryRole involves managing end to end medical safety activities in a hybrid work model for global pharma research and development initiatives with focus on high quality safety data review and risk assessment while ensuring compliance with regulatory standards and supporting effective product benefit risk evaluation for improved patient outcomes and healthcare advancement
Responsibilities
Manage medical safety review activities for assigned products ensuring consistent evaluation of safety data and timely identification of potential risks to safeguard patient wellbeing and uphold regulatory expectations
Coordinate safety data collection and documentation for clinical and post marketing settings ensuring accurate entry of information and high quality narratives that support robust safety analyses
Conduct detailed medical safety assessments of individual case safety reports to confirm clinical relevance and clarity of reported events and to provide meaningful input into aggregate safety evaluations
Collaborate with cross functional pharma research and development teams to integrate safety insights into study design protocol amendments and development plans enhancing the scientific rigor and ethical standards of projects
Monitor emerging safety signals from internal databases and external sources and document medical rationale for signal validation escalation and follow up contributing to proactive risk management strategies
Prepare and review safety related documentation for regulatory submissions and internal governance meetings ensuring alignment with global safety regulations and company standards for medical accuracy
Support continuous improvement of safety review workflows by proposing enhancements to templates guidance documents and quality checklists that streamline case processing and improve consistency of medical assessments
Engage with pharmacovigilance case processing teams to clarify medical aspects of complex cases and to ensure that coding seriousness criteria and outcomes are medically sound and aligned with global safety practices
Contribute to benefit risk assessments by summarizing key safety trends and medical judgments enabling informed decision making on labelling recommendations risk minimisation activities and communication to healthcare professionals
Utilize hybrid work arrangements effectively by maintaining clear documentation communication and collaboration practices that ensure uninterrupted support for global safety operations during day shifts without travel requirements
Participate in training and knowledge sharing sessions on evolving pharmacovigilance guidelines therapeutic area insights and internal systems to maintain up to date medical safety expertise that benefits project quality and societal health outcomes
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Provide constructive feedback on safety database outputs dashboards and metric reports to improve the clinical interpretability of safety information and support data driven decisions across research and development programs
Support ethical and patient centric safety culture by consistently advocating for accurate reporting transparent communication of risks and responsible use of safety data to strengthen trust in medicines and protect communities
Qualifications
Demonstrate practical experience in pharma research and development with hands on involvement in safety or clinical documentation activities that build strong understanding of drug development and regulatory expectations
Apply working knowledge of pharmacovigilance case processing workflows including intake data validation coding and follow up activities to support high integrity safety reporting and efficient case management
Use medical judgment in pharmacovigilance medical review activities such as narrative evaluation seriousness assessment and causality considerations to enhance the clinical depth and value of each case assessment
Bring familiarity with global safety regulatory frameworks and guidelines relevant to pharmacovigilance to ensure that all safety activities remain compliant and support timely regulatory interactions
Operate effectively in hybrid work settings using digital collaboration tools structured documentation and proactive communication skills to maintain productivity and alignment with onsite and remote team members
Leverage strong analytical and problem solving skills to interpret complex clinical data identify meaningful patterns in safety information and propose medically sound recommendations that aid safer use of medicines
Communicate clearly in written and verbal formats with diverse stakeholders including clinical teams regulatory colleagues and safety operations staff to ensure shared understanding of safety concerns and actions
Maintain high attention to detail and quality focus in all safety related deliverables safeguarding accuracy completeness and consistency which directly supports public health and company reputation
Certifications RequiredPreferred certifications include pharmacovigilance or drug safety credentials such as certification in global pharmacovigilance or clinical research
About Cognizant:
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, bridging the gap between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, drive tangible outcomes and keep global enterprises ahead in a fast-changing world. See how at cognizant.ai or @cognizant. Additional employment information Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law. Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview. Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
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