Job Title
Assistant Manager – Case Processing (Pharmacovigilance)
Location
Noida, India
Category
Consulting
Employment Type
Full Time
Posted Date
July 16, 2025
Job ID
R2513120
Work Mode
On-site (with client audit participation and training activities)
Compensation / Salary
Not disclosed in the job description (competitive salary and benefits offered).
Job Summary
Cencora (PharmaLex India Pvt. Ltd.) is hiring an Assistant Manager – Case Processing in Noida to lead pharmacovigilance case processing activities across spontaneous, clinical trial, health authority, and literature cases. This leadership role covers ICSR submissions, CIOMS/MedWatch form preparation, compliance oversight, audits, and mentoring of PV staff. The ideal candidate will have advanced pharmacovigilance expertise, strong team management skills, and a proven track record of regulatory and quality compliance in drug safety operations.
Key Responsibilities
Perform triage and review for initial validity assessment of all PV cases (spontaneous, health authority, clinical trial, literature).
Oversee quality management, compliance management, and document control for assigned PV projects.
Evaluate and ensure expedited reporting to Health Authorities/partners, adhering to regulatory timelines.
Prepare CIOMS I, MedWatch forms, and XML files for case reporting.
Manage ICSR submissions to Health Authorities and partners.
Act as line manager for assigned PV staff, overseeing recruitment, training, and goal-setting.
Coordinate resource allocation and project activities to meet client KPIs.
Conduct mentoring and training sessions for PV team members.
Ensure training compliance and maintain updated departmental CVs, job descriptions, and training records as per SOPs.
Lead client audits and regulatory inspections, ensuring full compliance with internal and external standards.
Write/review SDEAs, SOPs, working instructions, templates, and project metafiles for PV projects.
Monitor monthly invoices and ensure accurate billing for PV clients.
Provide constructive feedback and performance appraisals to foster team growth.
Support QA documentation, case completion, and data entry QC activities.
Required Skills & Qualifications
Bachelor’s or Master’s degree in Life Sciences (Pharmacy, Biotechnology, Medicine, or related field).
5–8 years of experience in pharmacovigilance case processing and ICSR submissions.
In-depth knowledge of MedDRA, CIOMS, MedWatch, ICH-GCP, and GVP regulations.
Proven expertise in case triage, data entry, quality review, and expedited reporting.
Familiarity with PV databases, safety reporting tools, and XML/ICSR processing.
Strong leadership skills with prior experience managing PV teams.
Excellent understanding of audits, regulatory inspections, and compliance frameworks.
Exceptional communication and stakeholder management skills.
Strong problem-solving skills and ability to handle multiple projects.
Perks & Benefits
Competitive compensation and benefits package aligned with the Indian pharma market.
Exposure to global pharmacovigilance processes and regulatory frameworks.
Opportunity to lead PV teams and interact with international Health Authorities.
Professional growth in a global healthcare consulting leader.
Supportive, inclusive, and compliance-driven work environment.
Company Description
Cencora, through its affiliate PharmaLex India Pvt. Ltd., is a leading global provider of drug safety, regulatory, and compliance services. Dedicated to creating healthier futures, Cencora partners with life sciences companies worldwide to ensure product safety and regulatory excellence across all therapeutic areas.
Call-to-Action
Ready to lead pharmacovigilance operations and ensure drug safety excellence? Apply now with your updated resume, highlighting ICSR submission, CIOMS/MedWatch, team leadership, and PV compliance expertise.
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