[제약/임상] Sr. PV & Clinical Operation

An international pharmaceutical company is searching for a Sr. PV & Clinical Operation. The selected candidate will oversee PV activities, regulatory safety reporting, RMP/rPMS execution, and clinical trial support.

Responsibilities:

• Oversee PV operations managed by CROs and agencies, including KPI monitoring, service quality review, and escalation of issues beyond contractual scope
• Coordinate submission of regulatory safety documents (PSUR/PBRER, RMPs, re-examination reports) that incorporate both PV and PMS findings
• Lead the full execution of rPMS and risk minimisation activities as outlined in the RMP, including protocol development, approvals, reporting, and re-examination submissions
• Manage SDEA contracts, including drafting, negotiation, execution, and renewals, to ensure alignment with global and local regulatory standards
• Provide direct operational support for local and regional IIS/clinical trials in collaboration with Medical Affairs and CROs
• Ensure AE reporting timelines and responsibilities are aligned with SDEA provisions and vendor agreements
• Contribute to process optimisation across PV and clinical workflows to ensure audit readiness and documentation integrity
• Participate in inspection preparation activities and ensure internal systems are aligned with global compliance expectations

Requirements:

• Bachelor’s degree or above in pharmacy, life sciences, or medicine, or related field
• More than 8 years of combined experience in PV, PMS, or clinical operations within pharmaceutical companies or CROs
• Pharmacist is strongly preferred due to PV knowledge foundation; Nurses with CRO experience also considered, especially for patient-centred data interpretation in PMS or clinical contexts
• Working knowledge of global PV regulations, including ICH E2E (mandatory) and EU GVP Modules (preferred)
• Familiarity with safety databases (Argus) and basic understanding of signal detection principles
• Training in Qualified Person for Pharmacovigilance (QPPV) or PMS-specific courses is preferred
• Fluent level English; knowledge of 1 or 2 other languages

About the Company:

An international pharmaceutical company headquartered in Italy. The company is dedicated to providing high-quality, innovative treatments for a wide range of medical conditions, including rare and specialty diseases.

Keywords:

제약, 의료, 임상, 국제적

Job Ref: 6O1C4T