Job Summary
Serve as a safety and efficacy specialist in a global pharmacovigilance environment by supporting Pharma Research and Development activities with a focus on structured analysis of safety data and documentation. Contribute to high quality case handling compliance and continuous improvement that supports patient safety and advances innovative therapies in a hybrid day shift setting.
Responsibilities
- Support end to end pharmacovigilance activities by performing safety data review documentation and validation to ensure accurate assessment of benefits and risks for products handled in Pharma Research and Development.
- Perform timely case intake data entry and reconciliation activities in safety systems to maintain high data quality and compliance with internal standards and external regulatory expectations across hybrid work locations.
- Coordinate with cross functional teams in clinical regulatory and medical domains to clarify safety information and support consistent interpretation of adverse event trends for assigned studies and marketed products.
- Execute routine safety database queries and prepare structured outputs that enable analytics teams to identify patterns potential signals and emerging safety issues that may impact ongoing research programs.
- Maintain detailed documentation of case processing decisions coding rationales and follow up actions to ensure clear traceability and audit readiness for all pharmacovigilance activities.
- Apply company standard operating procedures and global regulations to daily tasks by following defined workflows for intake triage processing and closure of individual case safety reports.
- Collaborate with quality and process excellence teams by sharing observations on recurring data quality issues and suggesting pragmatic improvements to templates checklists and work instructions.
- Contribute to aggregate report inputs by providing well structured summaries of individual case handling experience that support comprehensive safety narratives for regulators and stakeholders.
- Utilize domain experience in PV data management to verify completeness consistency and coding accuracy of key case fields such as events products outcomes and reporter details.
- Apply PV case processing knowledge to prioritize critical cases manage seriousness and expectedness assessments and escalate potential signals in line with company safety governance.
- Support training and knowledge sharing by documenting best practices in data capture and case review enabling colleagues and new team members to achieve consistent quality in daily pharmacovigilance work.
- Promote responsible data use and patient centric thinking by ensuring that each case is treated with rigor and respect reinforcing the company purpose of improving health outcomes and trust in medical innovations.
- Align daily activities with hybrid work expectations by managing time secure remote access and onsite collaboration to maintain seamless delivery in a structured day shift schedule.
Qualifications
- Demonstrate practical experience in Pharma Research and Development by applying research oriented thinking to safety assessments documentation and cross functional collaboration in pharmacovigilance.
- Utilize working knowledge of PV data management by handling case intake database entry validation checks and coding activities that support robust downstream safety analytics.
- Apply exposure to PV case processing by performing seriousness assessment causality consideration and follow up tracking under supervision while adhering to defined operating procedures.
- Bring two to three years of relevant pharmacovigilance or related pharma safety experience with clear evidence of working on structured data sets documentation and compliance driven workflows.
- Use strong written and verbal communication skills to document safety information explain case decisions and collaborate with global stakeholders in a clear and professional manner.
- Employ sound analytical and problem solving skills to identify gaps in case information propose appropriate follow up steps and support continuous improvement of data quality.
- Apply familiarity with safety or clinical systems and common office software to manage case processing tasks reporting activities and secure information handling in a hybrid environment.
Certifications Required
Preferred certifications include pharmacovigilance or drug safety credentials such as a recognized Pharmacovigilance Professional program or equivalent industry safety training.
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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