General Manager – CDM/PV | Cognizant
Location: Mumbai Metropolitan Region (Hybrid)
Work Type: Full-time
Estimated Salary: ₹45–60 LPA (based on 8–10 years of leadership experience in PV and R&D)
About the Role:
Cognizant is seeking a highly experienced and certified General Manager – CDM/PV to lead its pharmacovigilance and safety operations. This senior leadership role involves overseeing PV case processing, ensuring regulatory compliance, driving strategic initiatives, and optimizing safety operations in alignment with global standards.
Key Responsibilities:
Lead and manage the Pharmacovigilance (PV) team to ensure high-quality case processing and regulatory reporting.
Oversee the end-to-end safety operations, ensuring accuracy, compliance, and timely submissions.
Define and execute strategic plans for PV and CDM operations in line with organizational objectives.
Collaborate cross-functionally with Regulatory Affairs, Clinical Research, Quality Assurance, and other stakeholders.
Monitor, analyze, and interpret safety data to detect trends and potential safety signals.
Develop and implement risk management plans (RMPs) and mitigation strategies.
Ensure thorough documentation and reporting of adverse events (AEs/SAEs).
Conduct audits and inspections to ensure continuous regulatory and operational compliance.
Drive process improvement initiatives and promote a culture of innovation.
Lead training and mentoring of team members in PV best practices and regulatory requirements.
Manage departmental budgets, staffing plans, and resource allocation.
Serve as a key liaison with regulatory authorities for safety-related submissions and queries.
Qualifications & Requirements:
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or Medicine.
8–10 years of progressive experience in Pharma R&D, Pharmacovigilance, and Safety Operations.
Certified Pharmacovigilance Professional (CPP) or equivalent certification is mandatory.
Demonstrated leadership in managing large PV teams and complex safety portfolios.
Proficient in PV regulations, case management systems, and global safety compliance standards (ICH-GCP, FDA, EMA).
Strong command over data analytics, signal detection, and risk evaluation.
Experience in audit readiness, handling inspections, and CAPA implementation.
Proven ability to drive transformation, mentor teams, and manage cross-functional collaboration.
Excellent communication, organizational, and budget management skills.
Why Join Cognizant?
Be part of a global leader in digital health transformation and pharmaceutical R&D services.
Lead high-impact pharmacovigilance operations that contribute to patient safety and drug efficacy.
Enjoy a hybrid work culture, professional development opportunities, and a platform to drive change.
Work in an environment that values innovation, leadership, and compliance excellence.
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