Manager – Case Processing
Pharmacovigilance Operations
Location: Noida, India
Employment Type: Full-Time
Category: Consulting
Posted Date: November 10, 2025
Job ID: R2515924
Affiliated Entity: PharmaLex India Private Limited (A Cencora Company)
About Cencora
Cencora is a global healthcare services organization committed to advancing patient safety and public health through science-driven, compliant, and scalable solutions. With a strong presence across the pharmaceutical, biotechnology, and life sciences sectors, Cencora partners with clients worldwide to deliver high-quality pharmacovigilance and regulatory services. Our people are central to our mission of creating healthier futures globally.
Role Overview
Cencora is seeking an experienced Manager – Case Processing to lead and manage pharmacovigilance case processing activities across multiple projects. This role combines operational oversight, people management, regulatory compliance, and client-facing responsibilities, ensuring high-quality delivery of ICSR processing in accordance with global regulatory standards.
The position requires strong leadership capabilities, deep knowledge of pharmacovigilance workflows, and hands-on experience with case triage, reporting, and audit readiness.
Key Responsibilities
Perform and oversee case triage and initial validity assessment for spontaneous, health authority, clinical trial, and literature cases.
Manage quality, workload, compliance, and document management activities for assigned pharmacovigilance projects.
Evaluate the requirement for expedited reporting to Health Authorities and business partners, including assessment of regulatory timelines.
Oversee the preparation of standard regulatory reporting forms such as CIOMS I, MedWatch forms, and XML files.
Ensure timely preparation, dispatch, and tracking of follow-up requests.
Supervise and ensure accurate submission of ICSRs to global Health Authorities and client partners.
Act as line manager for assigned pharmacovigilance staff, providing leadership, guidance, and performance oversight.
Manage project coordination, resource planning, and workload allocation across PV teams.
Train, mentor, and continuously develop PV department staff to ensure regulatory compliance and process excellence.
Oversee recruitment activities for the Pharmacovigilance department, including interview participation and onboarding support.
Ensure departmental CVs, job descriptions, training records, and competency matrices are complete, current, and SOP-compliant.
Participate in goal setting, annual performance appraisals, and career development planning for team members.
Ensure continuous training compliance and readiness of PV staff.
Represent the Pharmacovigilance department during client audits, for-cause audits, routine audits, and regulatory inspections.
Ensure compliance with internal quality standards, SOPs, and national and international pharmacovigilance regulations.
Author, review, and maintain QA and PV documentation including SOPs, Working Instructions, SDEAs, templates, project metafiles, and procedural documents.
Organize and deliver training on updated procedures and quality documents.
Support hands-on case processing, including data entry, quality control, case completion, and documentation as required.
Actively mentor new joiners, supporting their integration and professional development within the organization.
Perform additional responsibilities as assigned by management in line with operational requirements.
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related discipline.
Advanced training or certification in Pharmacovigilance is an advantage.
Experience Requirements
Minimum 7–10 years of relevant experience in Pharmacovigilance and Case Processing.
Proven experience in ICSR processing, regulatory submissions, expedited reporting, and audit support.
Demonstrated people management and project leadership experience within a PV or CRO environment.
Prior experience working with global clients and multiple regulatory regions is highly desirable.
Skills and Competencies
Strong knowledge of global pharmacovigilance regulations, timelines, and reporting requirements.
Excellent leadership, mentoring, and stakeholder management skills.
High attention to detail with strong documentation and quality management capabilities.
Ability to manage multiple projects, deadlines, and teams in a regulated environment.
Strong analytical, decision-making, and problem-solving abilities.
Excellent verbal and written communication skills in English.
Service-oriented mindset with experience in corporate and client-facing environments.
What Cencora Offers
Cencora provides a collaborative, inclusive, and professionally enriching work environment with opportunities to lead global pharmacovigilance programs. Compensation and benefits are aligned with local market practices and may vary by location and employment terms.
Equal Employment Opportunity
Cencora is an equal opportunity employer committed to fostering a diverse and inclusive workplace. Employment decisions are made without discrimination based on race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or any other legally protected status.
Reasonable accommodations are provided to qualified individuals with disabilities in accordance with applicable laws.
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