Job Title: PV Operations Job Location: Hyderabad / Bangalore / Pune

Work Model: Work from office

Candidate Expectations Total and Relevant Experience – 12 Years – 15 Years

Candidate Location - Anywhere

Skills – PV, ICSR

Candidate Industry (Life science)

Diversity – No

Education and Certification Qualification: Any Life Science Graduate

Specific Remarks: Distance education not accepted.

Certification : Not Applicable

Detailed Global PV Operations Leadership

- Lead and manage end-to-end pharmacovigilance operations across global markets.
- Oversee ICSR intake, triage, processing, medical review coordination, quality control, and regulatory submissions.
- Ensure compliance with expedited and periodic safety reporting requirements.
- Manage daily operational deliverables, resource allocation, workload distribution, and capacity planning.
- Establish operational governance, performance metrics, and productivity benchmarks.
- Drive operational excellence and continuous improvement initiatives.

Regulatory Compliance and PV Governance

- Ensure compliance with global pharmacovigilance regulations and guidelines, including:
- ICH guidelines (E2A, E2B, E2D and relevant updates).
- EU GVP modules.
- US FDA pharmacovigilance regulations.
- Applicable local regulatory requirements.
- Oversee implementation and maintenance of PV SOPs, work instructions, and processes.
- Ensure adherence to regulatory reporting timelines and contractual obligations.
- Lead PV compliance monitoring and risk mitigation initiatives.
- Support regulatory inspections, internal audits, and external audits.
- Drive deviation management, root cause analysis, CAPA, and effectiveness checks.

Case Processing and Safety Reporting Oversight

- Provide strategic oversight of global ICSR processing activities.
- Ensure appropriate case triage, prioritization, processing,



medical review coordination, and submission.
- Monitor case quality, accuracy, and compliance with reporting timelines.
- Oversee reliable, non-serious, solicited, spontaneous, literature, and clinical trial safety cases as applicable.
- Ensure appropriate follow-up strategies and case reconciliation.
- Monitor case backlog and implement corrective measures.

Vendor and Business Partner Management

- Manage CROs, third-party vendors, and safety service providers.
- Establish and monitor Service Level Agreements (SLAs), Key Performance Indicators (KPIs), and quality expectations.
- Conduct periodic vendor governance and performance review meetings.
- Oversee safety data exchange agreements and reconciliation processes.
- Identify vendor-related compliance risks and drive mitigation plans.
- Manage escalations and ensure timely resolution of operational issues.

Safety Systems and Technology

- Oversee PV safety database operations and system-related activities.
- Ensure appropriate utilization and maintenance of safety systems such as:
- Oracle Argus Safety.
- ARISg.
- Veeva Vault Safety.
- Other relevant pharmacovigilance platforms.
- Support system validation, user acceptance testing (UAT), upgrades, and implementation projects.
- Drive automation, digital transformation, and process optimization.
- Ensure data integrity, system compliance, and appropriate access controls.

Quality Management and Inspection Readiness





- Partner with Quality Assurance to maintain PV quality management processes.
- Lead preparation for regulatory inspections and PV audits.
- Ensure availability and accuracy of PV documentation and records.
- Monitor quality trends, error rates, deviations, and CAPA effectiveness.
- Drive preventive actions to reduce recurring quality issues.
- Support maintenance of inspection-ready PV processes.

Team Management and Development

- Lead, mentor, and develop PV operations teams.
- Manage team performance, productivity, training, and competency development.
- Establish individual and team objectives aligned with organizational goals.
- Develop succession planning and resource management strategies.
- Foster a culture of accountability, quality, and continuous improvement.

Cross-Functional Collaboration

- Collaborate with Regulatory Affairs, Clinical Operations, Medical Affairs, Quality Assurance, and Medical Safety teams.
- Provide operational inputs for global safety initiatives.
- Participate in governance meetings and strategic business reviews.
- Manage client relationships and senior stakeholder communications.
- Support new product onboarding, transition activities, and PV process integration.

Technical and Functional Expertise

- Global PV operational oversight.
- MedDRA and WHO Drug coding knowledge.
- ICH E2B(R2)/(R3) reporting requirements.
- Global expedited and periodic safety reporting.
- Safety database management and oversight.
- PV quality management and audit readiness.
- Vendor governance and SLA management.
- PV metrics, dashboards, and performance analytics.
- Process transformation and automation.

Key Skills End-to-end ICSR management and safety reporting. Other Specific Remarks Additional Requirements: Proper documents for entire career and PF Form 16 Mandatory

📌 PV Operations - Head - GO/JC/4949/2026 (Hyderabad)
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