Assistant Manager – Case Processing (Pharmacovigilance)
Location: Noida, India
Employment Type: Full-Time
Experience Required: 3–6 Years in Pharmacovigilance / Drug Safety Operations
Job ID: R2513120
Category: Consulting / Pharmacovigilance
About Cencora
Cencora is a global leader in healthcare solutions, dedicated to creating healthier futures through innovation, compliance, and operational excellence. Our teams drive world-class pharmacovigilance (PV), regulatory, and clinical operations to ensure patient safety and regulatory compliance. Every team member contributes directly to delivering high-quality outcomes for clients and patients worldwide.
Job Summary
The Assistant Manager – Case Processing is responsible for overseeing pharmacovigilance operations, ensuring accurate case processing, regulatory compliance, and quality management for assigned projects. This role combines team leadership, project coordination, and operational execution to maintain PV standards in alignment with global regulatory guidelines.
The ideal candidate has 3–6 years of experience in pharmacovigilance operations, ICSR management, and drug safety reporting, with demonstrated leadership in mentoring and supporting PV teams.
Key Responsibilities
Case Processing & Regulatory Compliance:
Perform triage and initial validity assessment of cases, including spontaneous reports, health authority notifications, clinical trial cases, and literature cases
Determine the need for expedited reporting to Health Authorities and client partners, ensuring adherence to reporting timelines
Prepare and submit standard reporting forms, such as CIOMS I, MedWatch forms, and XML files
Generate follow-up requests to obtain additional case information and ensure completeness of documentation
Maintain accurate data entry, quality control, and case completion documentation in compliance with SOPs
Team Leadership & Training:
Act as line manager for assigned PV staff, providing mentorship, training, and performance feedback
Facilitate onboarding and professional development for new team members
Ensure training compliance, maintain departmental records, CVs, and job descriptions as per SOPs
Support goal setting and conduct annual appraisals, aligning team objectives with organizational goals
Project Management & Operations:
Manage project coordination, workload distribution, and resource allocation for assigned PV projects
Oversee generation and sharing of monthly invoices for PV clients
Support recruitment and team expansion within the PV department
Represent the PV team during client audits or regulatory inspections
Draft, review, and maintain QA documents, SOPs, work instructions, templates, and project metafiles
Process Improvement & Collaboration:
Actively participate in process improvement initiatives to enhance PV operations efficiency
Provide guidance on PV workflows, ensuring consistent compliance with internal standards and global regulatory requirements
Foster a collaborative work environment to support knowledge sharing and continuous learning
Required Qualifications
Education: B. Pharma, M. Pharma, BDS, or Life Sciences graduate
Experience: 3–6 years in pharmacovigilance operations, case processing, or drug safety
Strong knowledge of ICSR processing, MedDRA coding, safety reporting, and regulatory compliance
Proven experience in team management, training, and project coordination
Excellent communication, interpersonal, and organizational skills
Ability to manage multiple priorities and ensure quality and compliance in a fast-paced environment
Why Join Cencora
Lead and manage global pharmacovigilance operations in a collaborative environment
Gain exposure to regulatory reporting, safety surveillance, and compliance oversight
Career growth opportunities with structured mentorship and professional development programs
Inclusive, supportive, and equal opportunity workplace committed to employee growth and excellence
Participate in impactful healthcare projects improving patient safety and outcomes worldwide
Cencora is an Equal Opportunity Employer and provides reasonable accommodations for individuals with disabilities in compliance with applicable legal requirements.
Apply Now on ThePharmaDaily.com to advance your career in pharmacovigilance case processing and regulatory operations with a global leader.
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