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Arcolab is hiring an experienced Delivery Operations Leader – Pharmacovigilance for its Bangalore location. This senior leadership position is ideal for professionals with extensive expertise in ICSR case processing, MICC operations, SDEA management, and global PV compliance. If you have a strong background in pharmacovigilance operations, team leadership, and CRO delivery excellence, this opportunity offers a high-impact role in a rapidly scaling PV environment.
Key Responsibilities
1. ICSR Case Processing Leadership
- Lead and manage global ICSR case processing operations.
- Ensure accurate and timely reporting of adverse events.
- Monitor SLAs, KPIs, and quality metrics for continuous improvement.
- Implement automation, best practices, and efficiency measures.
- Collaborate with cross-functional teams to streamline workflows.
2. MICC (Medical Information Call Center) Management
- Oversee MICC call-center operations ensuring proper triage and documentation.
- Standardize workflows and ensure SOP adherence.
- Track SLAs, service quality, call metrics, and performance.
- Coach MICC supervisors and associates to enhance operational excellence.
3. SDEA Oversight
- Manage global Safety Data Exchange Agreements.
- Ensure compliance with reporting timelines and regulatory requirements.
- Oversee partner data reconciliation and safety data exchange workflows.
- Monitor adherence to contractual quality and submission standards.
4. CRO Operational Setup & Support
- Support the design and scaling of PV operations within a CRO model.
- Develop SOPs, governance structures, and robust workflows.
- Ensure readiness for audits, inspections, and client onboarding.
- Drive operational transformation and organizational scalability.
Qualifications
- M.Pharm or equivalent Life Sciences degree.
- 12+ years of experience in pharmacovigilance (ICSR, MICC, SDEA).
- 5+ years in leadership or managerial roles.
- Experience managing large PV teams (50+ FTEs).
- Hands-on knowledge of PV databases and call-center systems.
- Strong understanding of global PV regulations and compliance frameworks.
Preferred Skills
- Experience in global PV delivery operations.
- Exposure to digital PV tools, automation, and AI-driven PV monitoring.
- Experience in handling regulatory inspections and multinational client audits.
Why Join Arcolab?
- Opportunity to lead a high-performing PV team of 80+ professionals.
- Work in a global regulatory environment with advanced PV systems.
- Exposure to CRO operational expansion and digital PV technologies.
- Strong platform for career growth in pharmacovigilance leadership.
How to Apply
Interested and eligible candidates may send their updated CV to:
Email: Dev.kiran@arcolab.com
Location: Bangalore
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Early applications are encouraged as the position is time-sensitive.
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