In our Global Pharmacovigilance and Risk Management team we are looking candidates for the following position:

Manager, Global Pharmacovigilance and Risk Management (Woman / Man)

Location:   Poland: Warsaw office hybrid / Poland Remote

Locations: Serbia, Bulgaria, Hungary, Romania

Key accountabilities:

• Independently conduct signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked. Identify potential signals, validate and prepare signal assessment reports, or other related documents. Contribute to analyses in external databases (e.g. EVDAS) using data mining methods for detection and evaluation of safety signals.
• Provide medical expertise during CCSI/CCDS, RMPs/REMS, aggregate reports and DSURs creation.
• Prepare Health Hazard evaluations (HHE's) and create respective documents in close cooperation with involved departments.
• Prepare responses to ad-hoc requests from regulatory agencies.
• Maintain pharmacovigilance expertise, understanding international safety regulations and guidelines.
• Understating emerging AI tools is advantageous.
• Develops, communicates, and implement best practices, SOPs, templates, work instructions, etc. as called for or specified in assigned tasks and projects.
• Work collaboratively with internal stakeholders, including members of Medical Affairs, Clinical Trials, and Regulatory Affairs, in a matrix environment as needed for specific project needs/plans.

Requirements to the candidates:

• Education/qualifications: Medical degree (MD or equivalent primary medical qualification, such as MBBS or bachelor’s in human medicine)or Veterinary degree.

• Have relevant pharmacovigilance experience (minimum 5 years) primary in signal detection.
• In-depth knowledge of signal detection and risk management principles.
• Thorough understanding of international pharmacovigilance regulations including EU, ICH, FDA guidelines and regulations.
• Knowledge of statistical software and use of drug safety database.
• Ability to manage complex tasks in a matrix environment.
• Strong organizational skills, detail oriented, ability to adapt in a fast paced constantly changing environment.
• Computing skills: user requiring advanced literacy (Microsoft Office applications, Adobe Acrobat).
• Excellent communication skills and ability to work within the team and cross-functionally.
• Fluency in English.

We offer:

• Work in a global role within an international setting

  •            Collaborate in a positive and supportive team environment

  •            Opportunity for continuous learning and professional growth within a team of experienced professionals