Senior PV Officer, Team Lead
Location: Warsaw, Poland (Remote option available)
Full-time
Department: ICSR Management
Company: PrimeVigilance (Part of Ergomed Group)
Company Overview:
PrimeVigilance is a global leader in pharmacovigilance services, committed to maintaining lasting partnerships with pharmaceutical and biotechnology companies. Since its founding in 2008, PrimeVigilance has grown organically across Europe, North America, and Asia. The company is dedicated to providing world-class support in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance, covering all therapy areas, including medical devices.
PrimeVigilance values its employees and invests in their development, promoting a healthy work-life balance and prioritizing employee well-being and mental health.
Job Overview:
As a Senior PV Officer, Team Lead, you will be responsible for overseeing a team managing Individual Case Safety Report (ICSR) activities for assigned projects. You will ensure that tasks are effectively distributed within the team, monitor project workflows, and collaborate with clients to optimize ICSR management processes. This role requires strong leadership, organizational skills, and a deep understanding of pharmacovigilance.
Key Responsibilities:
Team Leadership:
Lead the ICSR management team for specific projects, ensuring tasks are appropriately assigned and workflow processes are followed.
Line manage ICSR staff, providing support, training, and development.
Project Management:
Create and maintain project-specific Key Performance Indicators (KPIs) for ICSR activities.
Suggest and implement process improvements to increase team efficiency and enhance project outcomes.
Client and Internal Collaboration:
Ensure effective cooperation with clients in ICSR management.
Propose and manage ICSR process deviations with the support of the ICSR Operational Lead.
Case Processing & Quality Control:
Oversee ICSR processing and perform second-quality control checks for case handling.
Administrative & Reporting:
Review trackers and timesheet data, ensuring accuracy and compliance.
Maintain clear communication with team members and clients.
Qualifications:
Educational Background:
A degree in life sciences, pharmacy, nursing, or a related healthcare field, or substantial experience in pharmacovigilance.
Experience:
Extensive experience in pharmacovigilance, with demonstrated leadership or line management experience.
Skills:
Strong communication skills, both written and verbal.
Excellent organizational skills, attention to detail, and multitasking abilities.
Delegation, planning, and time management skills.
Technical proficiency relevant to the role and team coordination.
Team-oriented with the ability to support and collaborate with other specialists.
Why PrimeVigilance?
PrimeVigilance is committed to fostering a diverse, inclusive, and human-first workplace. The company values its employees and provides opportunities for professional growth and development. If you share the company’s core values—Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships—PrimeVigilance is the place for you.
Key Benefits:
Internal training and career development opportunities.
A collaborative, supportive environment with a global team.
Work in an organization that emphasizes employee well-being and work-life balance.
If you're an experienced leader in pharmacovigilance and looking for a dynamic, global team to join, apply now to become a part of PrimeVigilance and help make a positive impact on patient safety!
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