Senior Pharmacovigilance Manager

🔥 3 hours ago

🇨🇿 Czechia – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 15%

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iVigee

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2021

💊 Pharmaceuticals

🏥 Healthcare

🤖 Artificial Intelligence

Pharmaceuticals • Healthcare • Artificial Intelligence

iVigee is a physician-led pharmacovigilance company that provides end-to-end drug safety solutions for pharmaceutical and biotech organizations. iVigee offers managed pharmacovigilance services, expert consultancy, and pharmacovigilance technology (including AI-enabled tooling) to automate PV workflows, ensure regulatory compliance, and support inspection-ready processes. The leadership team includes former regulators and senior physicians, and the firm highlights AI strategy, validated agentic AI deployment, and global/local regulatory expertise with offices in Prague and Burlington, MA.

📋 Description

• Lead and oversee complex pharmacovigilance projects • Ensure high-quality service delivery in line with regulatory requirements and client expectations • Serve as the main point of contact for key PV initiatives and important client projects • Provide senior-level guidance, mentorship, and supervision to junior PV colleagues and project teams • Contribute to department strategy, processes, and quality standards • Take full responsibility for delivery of complex PV services, including strategic oversight, planning, and coordination of cross-functional PV activities • Author or review PV documents according to client specifications, project instructions, internal rules, and applicable legislation • Participate in development and maintenance of the iVigee quality management system • Prepare internal SOPs, working instructions, and client SOPs • Ensure compliance of PV activities with legislation and internal and client procedures • Participate in or lead interactions with regulatory authorities, inspections, and audit responses • Act as audit coordinator during vendor qualification audits, client service audits, regulatory inspections, and client audits of iVigee PV services • Deputize in accordance with the internal responsibility matrix • Promote knowledge sharing and best practices across PV project teams • Represent the PV department in cross-functional initiatives and management-level meetings • Maintain current awareness of PV legislation and regulatory guidance • Mentor, support, and train junior PV team members • Provide input into individual development and performance management • Participate in building systems for medical device vigilance and cosmetovigilance • Support other PV activities as requested

🎯 Requirements

• University degree in medicine, pharmacology, life sciences or other healthcare professional fields • 5+ years of experience directly in pharmacovigilance • Pharmacovigilance System Master File (PSMF) authoring and management • Local PV Network management • Coordination and management of additional Risk Minimisation Measures (aRMM) — an advantage • EU QPPV or Deputy EU QPPV role — an advantage • Managerial and organization skills • Communication skills • Presentation skills • Team working • Ability to motivate people and leadership • Fluent English • Advanced literacy in Microsoft Office applications

🏖️ Benefits

• Good work-life balance • Long-term relationships and lasting solutions • Opportunity to work with AI-enabled pharmacovigilance tools and innovative technologies • Professional development through mentorship, training, and knowledge sharing • Participation in management-level meetings and cross-functional initiatives • Opportunity to work with global clients and experts in over 150 countries

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