Cognizant, a global leader in professional services, is looking for a Senior Process Executive-CDM/PV with expertise in Generative AI and a strong background in Research & Development (R&D) or Pharmacovigilance (PV) Case Processing. This role offers a unique opportunity to work on cutting-edge AI-driven solutions while ensuring compliance with regulatory standards in drug safety and clinical data management.
Key Responsibilities
- Lead the implementation of Generative AI solutions to enhance process efficiency in CDM (Clinical Data Management) and PV (Pharmacovigilance).
- Oversee PV case processing, ensuring compliance with global regulatory standards (FDA, EMA, ICH-GCP).
- Develop and optimize AI models for data management and automation in drug safety.
- Collaborate with cross-functional teams to drive innovation in R&D and clinical trials.
- Ensure high-quality, timely processing of adverse event reports (AEs) and safety data.
- Conduct data trend analysis to improve workflows and compliance.
- Train and mentor junior team members on AI applications in pharmacovigilance.
- Maintain SOPs (Standard Operating Procedures) and documentation for audits.
- Participate in project planning and strategic decision-making.
Qualifications & Skills
- 2 to 6 years of experience in PV case processing, clinical data management (CDM), or AI-driven research.
- Strong expertise in Generative AI and its applications in pharma/life sciences.
- Knowledge of Argus, Veeva, or other PV databases is a plus.
- Excellent analytical and problem-solving skills.
- Ability to work in a hybrid model (remote + onsite).
- Strong communication and stakeholder management skills.
- Experience in training junior team members.
- Familiarity with regulatory guidelines (GxP, ICH, FDA, EMA).
Certifications Required
- Certified AI Practitioner
- PV Case Processing Certification (e.g., Argus, MedDRA, WHO-DD)
Why Join Cognizant?
- Innovative Work Environment: Work on AI-driven pharmacovigilance and clinical data projects.
- Global Impact: Contribute to life-saving drug safety initiatives.
- Career Growth: Access to upskilling programs and leadership opportunities.
- Inclusive Culture: Cognizant is recognized among Forbes World’s Best Employers (2024).
About Cognizant
Cognizant (NASDAQ: CTSH) is a Fortune 500 company and a global leader in digital transformation, AI, and healthcare IT. With over 350,000 employees worldwide, we help pharmaceutical and biotech companies streamline drug safety, clinical trials, and regulatory compliance through AI and automation.
How to Apply
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