Our partner has a strong position in the local pharmaceutical market and focuses on areas of significant unmet medical need and places where the company has the expertise to make a difference.
- Ensures the collection, reporting, and handling of safety information associated with the products is performed according to global and local regulatory requirements within the assigned PV hub coverage areas.
- Proactively manages workload to ensure regulatory timelines are met.
- Records management coordinator for the PV unit.
- Performs accurate data capture of adverse event reports associated with company products onto the safety database in accordance with internal processes and local and international regulatory requirements.
- Performs post surveillance activities such as literature review and media monitoring.
- Performs reconciliation activities associated with Pharmacovigilance Agreements and various other sources such as product complaints, medical information inquiries, and MAPs.
- Performs and documents contact tests for drug safety to test the mechanisms of reporting to the Local Safety Unit.
- Supports the team in ensuring high standards are maintained and opportunities for departmental improvements are identified and implemented.
- Health Care Professional Degree (e.g. Pharmacist, Registered Nurse, Bachelor of Science in Nursing, Physician Assistant, Nurse Practitioner) or Life Science Degree (e.g. BSc Biology, BSc Neuroscience, etc.)
- Previous operational experience in Drug Safety/Pharmacovigilance (preferred)
- Strong knowledge of medical terminology
- Good command of English both written and verbal
- Knowledge of global Pharmacovigilance regulatory requirements
- Ability to evaluate, analyze and interpret data and draw conclusions independently
- Strong organization skills, detail-oriented, ability to adapt to change
- Effective team player, demonstrating initiative and accountability
- Good interpersonal skills are required to build strong, sustainable and collaborative relationships with internal and external stakeholders, as well as effective collaboration with functional groups and management
- Ability to work under pressure and convey a sense of urgency
- Ability to work across cultures, including in a virtual environment
- Insight into the healthcare market of Hungary
- Solid experience, long-term job opportunity
- Professional training opportunities abroad
- Opportunity for continuous professional development, great carrier opportunities
- Practice in the methodology of one of the most recent individualized therapy
- Agile work, flexible working hours
- Home Office
- Competitive salary and benefit package