Pharmacovigilance Manager

Location
Prague
Salary
Competitive
Posted
Aug 17, 2022
Closes
Sep 15, 2022
Ref
3512
Function
Management
Industry
Science
Hours
Full Time
Pharmacovigilance Manager

Czech Republic - Remote

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Responsibilities
  • Project management: oversee and manage pharmacovigilance projects (both clinical trial safety and post-registration pharmacovigilance) in Europe; act as a Deputy for Qualified Person for Pharmacovigilance (Deputy QPPV) and Local Person for Pharmacovigilance (LPPV) for selected projects
  • Line management: lead a team of pharmacovigilance officers in Europe
  • Project start-up activities: communication with clients, contract and budget negotiation
  • SOP development: assist with pharmacovigilance processes set up and support preparation of written standard procedures
  • Maintain deep knowledge of current local and European pharmacovigilance legislation, providing pharmacovigilance training
  • Active participation during audits and inspections, internal quality control activities
  • Preparation of safety-related aggregate reports (PSUR, DSUR, ASR) if applicable

Experience
  • Pharma/medical/natural sciences university degree
  • Expected at minimum 3 years of experience in pharmacovigilance
  • Experience in post-registration pharmacovigilance (LPPV or QPPV Deputy) is an advantage
  • Advanced knowledge of English (both written and verbal) and fluent Czech or Slovak
  • Ability to work on several projects, focus on detail and meet deadlines
  • Solid interpersonal communication (verbal and written), people management and organization skills
  • Ability to work independently and solve problems
  • IT and presentation skills

We offer
  • Interesting and independent work with career growth opportunities within a global company with European headquarters in Prague city center
  • Friendly and professional working environment
  • One extra week of vacation
  • Flexible working hours
  • Possibility to work partially from home office
  • Multisport card, meal vouchers


CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - The Emmes Company, LLC

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