Manager, General Pharmacovigilance and Risk Management (Woman / Man)
Location
Poland: Warsaw office hybrid / remote. Additionally available in 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.
- Develop, communicate, 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
- Medical degree (MD or equivalent primary medical qualification, such as MBBS or bachelor’s in human medicine) or Veterinary degree.
- Minimum 5 years of relevant pharmacovigilance experience 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 with advanced literacy in Microsoft Office applications, Adobe Acrobat.
- Excellent communication skills and ability to work within the team and cross-functionally.
- Fluency in English.
Benefits
- 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.
We are an Equal Opportunity Employer. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
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