Manager – Pharmacovigilance Operations | ICSR Operations
Company: Amneal Pharmaceuticals
Location: Ahmedabad, Gujarat, India
Job Type: Full-Time | Onsite
Function: Pharmacovigilance / Drug Safety Operations
Experience Required: 8–12 years (including minimum 5 years in a managerial role)
Qualification: Doctor of Pharmacy (Pharm.D)
Job Status: Hot & Trending Role
Job Overview
Amneal Pharmaceuticals is seeking an experienced Manager – Pharmacovigilance Operations (ICSR Operations) to lead global case processing activities and ensure regulatory compliance across pharmacovigilance operations. This leadership role is critical in driving operational excellence, audit readiness, and high-quality safety case management in line with global regulatory standards.
The position is ideal for senior pharmacovigilance professionals with strong people management experience, deep regulatory knowledge, and hands-on expertise in global ICSR processing.
Key Responsibilities
Lead, mentor, and manage a global ICSR case processing team, fostering a high-performance and compliance-driven culture.
Oversee day-to-day pharmacovigilance operations, ensuring timely, accurate, and compliant processing of adverse event reports.
Manage intake, triage, and medical evaluation of adverse event reports, including assessments of seriousness, causality, and expectedness.
Conduct regular performance reviews, coaching, and development planning for team members.
Ensure compliance with global pharmacovigilance regulations, including ICH, FDA, EMA, and local authority requirements.
Collaborate with cross-functional stakeholders to resolve complex safety cases and support benefit–risk assessment activities.
Lead and implement CAPA initiatives in response to audits, inspections, deviations, and quality findings.
Ensure audit and inspection readiness, leading internal and external audits and supporting regulatory inspections.
Monitor key performance indicators (KPIs) and prepare operational and compliance reports for senior management.
Identify opportunities for process optimization, continuous improvement, and implementation of best practices in ICSR operations.
Develop, review, and maintain SOPs, work instructions, templates, and training materials related to pharmacovigilance operations.
Design and deliver comprehensive training programs for ICSR teams, ensuring adherence to regulatory and quality standards.
Provide inputs for responses to medical inquiries from regulatory authorities and healthcare professionals via MIRFs.
Support additional pharmacovigilance projects and initiatives as assigned by departmental leadership.
Required Skills & Competencies
Advanced knowledge of global pharmacovigilance regulations (ICH, FDA, EMA).
Expert-level experience in Individual Case Safety Report (ICSR) processing.
Strong expertise in MedDRA and WHO Drug coding standards.
Advanced hands-on experience with safety databases such as Argus, ArisG, and Veeva Vault Safety.
Deep understanding of global safety reporting requirements and timelines.
Strong command of data integrity principles (ALCOA+) and quality management systems.
Proven experience in CAPA management, root cause analysis, FMEA, and deviation handling.
Demonstrated leadership in audit and inspection readiness and regulatory interactions.
Solid knowledge of risk management principles (ICH Q9).
Strong people management, stakeholder communication, and decision-making skills.
Qualifications & Experience
Doctor of Pharmacy (Pharm.D) is mandatory.
Minimum 8 years of experience in pharmacovigilance, with at least 5 years in a managerial or leadership role.
Prior experience managing global teams and complex PV operations is highly preferred.
About the Company
Amneal Pharmaceuticals is a global pharmaceutical company committed to delivering high-quality, affordable medicines. The organization values integrity, innovation, and inclusion, and is dedicated to maintaining the highest standards of patient safety and regulatory compliance.
Amneal is an equal opportunity employer and does not discriminate on the basis of caste, religion, gender, disability, or any other legally protected status.
Why Join Amneal
Opportunity to lead large-scale global pharmacovigilance operations
Strong focus on quality, compliance, and operational excellence
Collaborative and inclusive work culture
Long-term career growth in drug safety leadershipa
Gujarat :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Netherlands |Remote Australia :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | Uxbridge | Richmond Hill | Australia | North York | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Kyiv |Lima Region :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
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