Role Overview
A delivery focused role combining Regulatory and Pharmacovigilance (PV) project management and coordination, responsible for ensuring timely and compliant execution of regulatory and PV activities across assigned projects.
The Senior Specialist will also act as Local Contact Person for Pharmacovigilance (LCPPV) for the designated country.
**Core Responsibilities
Project Management**
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Manage medium/high-complexity regulatory and PV projects, ensuring delivery against timelines, scope, and quality
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Oversee project setup, plans, and milestones, and coordinate across clients, LCP network, vendors, and internal teams
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Identify and mitigate delivery risks
PV & Compliance
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Act as LCPPV, ensuring compliance with local PV requirements and inspection readiness
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Support audits and inspections
Team & Operations
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Oversee LCP documentation (CVs, training, KPIs) and ensure training compliance
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Contribute to process improvements and standardization
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Support and guide junior staff
Financial & Operational Oversight
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Track scope, timelines, and budget, including OoS activities
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Support invoicing and monitor project performance, escalating deviations