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Ergomed

Pharmacovigilance Project Manager

1w

Ergomed

Sofia, BG · Full-time · BGN 48,000 – BGN 72,000

About this role

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We have achieved global organic growth with staff across Europe, North America and Asia covering pharmacovigilance, medical information, regulatory affairs and quality assurance. PrimeVigilance provides first class support to pharmaceutical and biotechnology partners across all therapy areas including medical devices.

As Pharmacovigilance Project Manager, act as the primary contact point for project-related matters and manage client expectations to ensure satisfaction. Prepare project scope and objectives based on signed agreements, plan activities with deadlines and milestones. Deliver reporting such as monthly reports serving as basis for invoicing to clients and management.

We value employee experience, well-being and mental health, acknowledging healthy work-life balance nurtures high-quality client service. Staff enjoy a friendly, supportive environment with colleagues worldwide, using English as the company language. Our core values include quality, integrity & trust, drive & passion, agility & responsiveness, belonging, and collaborative partnerships.

We prioritize diversity, equity, and inclusion creating an equal opportunities workplace. Invest in staff through excellent training and development platforms with strong emphasis on personal and professional growth. Join our exciting journey to make a positive impact in patients’ lives.

Requirements

  • Proven track record of pharmacovigilance activities including processing and quality review of ICSRs, writing or contributing to aggregate reports, literature screening, reconciliation, and preparation of SOPs
  • PV Project Management experience ideally from a service provider or CRO
  • Health Care Professional or Life Science Graduate
  • Comfortable communicating at senior levels within pharmaceutical organizations
  • Good leadership qualities including planning, mentoring, meeting facilitation, communication and problem solving

Responsibilities

  • Act as the primary contact point for project-related matters
  • Manage client expectations to ensure satisfaction with PrimeVigilance services
  • Prepare project scope and objectives based on signed agreements
  • Plan project activities including deadlines and interim milestones
  • Prepare reports for clients and PrimeVigilance management such as monthly reports for invoicing
  • Oversee pharmacovigilance activities including ICSR processing and quality review
  • Coordinate aggregate report writing and literature screening

Benefits

  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language