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Pharmacovigilance Manager

Emmes Biopharma Slovakia s.r.o.

Information about the position

  • Place of work: Remote work
  • Basic wage component (gross) and other rewards: From 1 600 EUR/month
  • Start date: 01/10/2022
  • Contract type: full-time

Job description, responsibilities and duties

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

Employee perks, benefits

• Interesting and independent work with career growth opportunities within a global company with European headquarters in Prague
• Friendly and professional working environment
• 25 vacation days
• Flexible working hours / home office
• Meal vouchers

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)

Educational Specialization

Pharmacovigilance, Clinical Research

Language skills

English - Upper intermediate (B2)

Other knowledge

Pharmacovigilance - Skillful

Experience in the position/sector

Pharmacovigilance

Number of years of experience

3

Advertiser

Brief description of the company

About Emmes
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.

Number of employees

25-49 employees