Senior Pharmacovigilance Manager

Why choose iVigee?

iVigee is a physician-lead pharmacovigilance exclusive company, combining deep regulatory expertise with AI-enabled tools (such as iViReg, iViTracker, iViSight) to support clients' drug safety life cycles.

Founded in 2021, all our leaders have years of experience in all areas of pharmacovigilance - science, regulations, and technology. Our acquisition strategy allows us to attract and choose both the best global talent, and companies.

Our world leading Pharmacovigilance Intelligence platform iViReg is the first to truly focus on the needs of PV professionals, and as we open that system up with our AI interface, we continue to embrace the current and future needs of the pharmacovigilance community and demonstrate our commitment to it.
Our advanced expertise in pharmacovigilance and technology keeps us two steps ahead, delivering sustainable, progressive, and seamless solutions. With strategic centres of excellence in Europe and the US, and our network of experts in over 150 countries, we service the complex global needs of our clients with speed and ease.

We hire for values as much as we hire for expertise. Our culture is built on a shared belief in doing PV the right way, with honesty, ambition, and a genuine care for the work. If these values resonate with you, you'll fit right in.

Fearless

We are not afraid of big tasks and challenges. Not timid to speak up, not timid to ask. Always seek and speak the truth.

Trustworthy professionals

Our competence gives us confidence that we will deliver on our promises. We do it with integrity and quality that earns trust. We do it with a smile, as we love our work that makes our clients happy, saves life and prevents harm.

Enabling innovation

Best practices and tools are giving us our competitive advantage. We are early adopters. We iterate frequently to be better than yesterday, every day.

Sustainable manner

We are interested in long-term relationships, lasting solutions, and good work-life balance. We improve our environment, support communities, raise talent, and build our company to last.

As a company applying the Topgrading methodology, we conduct a thorough recruitment process covering your career history, achievements, challenges, important decisions and key professional relationships. At the final stage, shortlisted candidates will be asked to arrange reference calls with selected former supervisors.

Purpose of the job position:

• To lead and oversee complex pharmacovigilance (PV) projects, ensuring high-quality service delivery in line with regulatory requirements and client expectations
• To serve as the main point of contact for key PV initiatives and important client projects
• To provide senior-level guidance, mentorship, and supervision to junior PV colleagues and project teams
• To contribute to the development and implementation of department strategy, processes, and quality standards

MAJOR TASKS AND RESPONSIBILITIES:

• Full responsibility for the delivery of complex PV services to clients, including strategic oversight, planning, and coordination of cross-functional PV activities
• Authoring or review of PV documents in compliance with the client´s specification, project-specific instruction, internal working rules, and applicable legislation
• Participation in iVigee quality management system development and maintenance, preparation of internal SOP/working instructions, and preparation of client’s SOPs
• Compliance of PV activities with legislation, internal and client’s procedures
• Participate in or lead interactions with regulatory authorities, including inspections and audit responses; act as audit coordinator during vendor qualification audits, audits conducted as a service for clients, inspections by regulatory authorities, or audits performed by clients on iVigee’s PV services
• Effective deputizing in accordance with the internal responsibility matrix
• Promote knowledge sharing and best practices across PV project teams
• Actively participate in management-level meetings and represent the PV department in cross-functional initiatives
• Maintain current awareness of PV legislation and regulatory guidance and apply it to strategic decision-making
• Mentor, support, and train junior PV team members; provide input into individual development and performance management
• Be open to new areas of vigilance (e.g., medical device vigilance, cosmetovigilance) and participate in building relevant systems
• Support other PV activities as requested

Specific requirements for the position: Education

University degree in medicine, pharmacology, life sciences or other healthcare professional fields

Experience

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

Special skills

Managerial and organization skills

Communication skills

Presentation skills

Team working

Ability to motivate people, leadership

Language skills

English (fluent)

Computer skills

Advanced literacy (Microsoft Office applications)