full time permanent employment in a young working environment and positive culture.
Under the supervision of the QPPV, the Pharmacovigilance Specialist will provide general support for the maintenance and continuous improvement of the PV System. He/she is responsible for ensuring accurate collection, database entry, review, and reporting of clinical trial and post-marketing safety data. As Deputy QPPV may be required to assist QPPV in signal generation, safety analysis activities, and in development and implementation of Company procedures and guidelines.
Essential tasks and responsibilities:
- Collection and recording of safety reports from any source (spontaneous, reports from study, literature, clinical study).
- Handling case processing: safety review and analysis of adverse events for clinical and post-marketing product reports, including triage, case review, narrative writing, MedDRA coding, evaluation of listedness/expectedness, and interface with reporters or investigators.
- Determine when a received report has to be reported or communicated according to the relevant Swiss/EU/Global regulations and Company procedures, ensuring on-time submissions.
- Reporting of cases in the required format by local regulations or agreements, including translation into foreign languages.
- Handling of quality defect with safety impact.
- As Deputy QPPV, support the QPPV function, ensuring constant compliance with Swiss and global PV Legislation and maintaining the company’s Pharmacovigilance system.
- Perform literature search for ADRs on a weekly basis ensuring effective and accurate collection, recording, review and reporting of literature searches conducted.
- Interface with medical reviewers and partners on adverse events and other safety-related issues.
- Conduct reconciliation activities with partners according to information sources and agreement in place.
- Conduct active follow-up activities, including written and verbal follow-up report.
- Knowledge of EudraVigilance database and related tools for submission and signal detection.
- Filing safety information according to Company archiving practices.
- Contribute to the compilation of aggregate reports such as periodic safety update reports (PSURs) and development safety update reports (DSURs).
- Contribute to the development and maintenance of company’s main documents: Pharmacovigilance Site Master File (PSMF), Risk Management plan (RMP), Safety Data Exchange Agreement (SDEA’s).
- Contribute to prepare and maintain pharmacovigilance SOPs to ensure compliance with PV requirements imposed by applicable laws and regulations and with company standards.
- Conduct specific Company projects, as needed.
Knowledge and Skills
- Degree in health sciences discipline (e.g. pharmacist, Pharmaceutical Science or related discipline)
- At least 3 – 5 years’ pharmacovigilance experience
- Aged between 28 – 32 years
- Deep knowledge of pharmacovigilance legislation and regulations (Swiss/EU/GCC/LATAM)
- Experience in pharmaceutical company
- Italian mother tongue, fluent in written and spoken English
- Experience with use of safety databases and EudraVigilance tools
- Preferably regulatory knowledge
- Organizational skills and pharmacovigilance project management skills
- Strong communication skills
- Proactivity, autonomy, precision, good teamwork skills, excellent planning skills, meeting deadlines, good stress management, ability to cope with tight schedules
- Commitment to continuous improvement
Interested candidates should send their CV by email to Cristina Robotti at firstname.lastname@example.org or by post to the address below.
For further information please call the following number: +41 91 911 30 00.
We thank all applicants for their interest, but only candidates selected for an interview will be contacted.
MAXIMUM DISCRETION AND PROFESSIONALISM FULLY GUARANTEED.
La candidatura al presente annuncio presuppone l’accordo con la nostra informativa inerente la protezione dei dati: https://www.luisoni.ch/protezione_dei_dati