Berufsbezeichnung: Sr. Pharmacovigilance Leader (w/m)

Arbeitsbeschreibung:
You looking for a challenge as a Sr. Pharmacovigilance Leader? Then support us with your expertise at our location in Switzerland. Ihre Aufgabe 1. Acts as the primary contact point with PVE in HYD, CSS and co-ordinates product-specific activities. 2. Performs medical review of individual SAEs from clinical trials with the support of the PVE as applicable and is responsible for preparation/submission investigator notifications 3. Performs medical evaluation of quality defects. 4. Acts as back-up for medical review and assessment and related activities for single cases (post-marketing and/or clinical trials), including requesting additional medically relevant information. 5. Identifies safety signals based on the review of solicited or unsolicited single case reports, aggregate data and signal detection tools (i.e. EMPIRICA) and performs signal evaluation and monitoring. 6. Prepares clinical expert statements related to signal evaluation (e.g. literature, clinical; non-clinical, epidemiology). 7. Provides input in responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CPO requests involving safety issues. 8. Provides Pharmacovigilance input to initial development of basic prescribing information and is responsible for Pharmacovigilance input to updates of this information. 9. Responsible for medical input to aggregate clinical safety regulatory reports (e.g., PSUR, DSUR). 10. Responsible for drug safety input to safety profiling plan and risk management plans. 11. Responsible for Case Retrieval Strategy and of ad hoc searches in Argus. 12. Provides guidance as appropriate to Clinical Safety Operations for the coding and causality/expectedness assessment of adverse event reports. 13. Provides expert evaluation on the clinical context of adverse event reports, assessment on the medical conditions, and the implications on Novartis drugs. 14. Responsible for medical input into PGD and e-signing of PGD. 15. Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments. 16. Provides relevant input for internal and external boards and expert panels, as well as internal management teams as SPT, SMT, ICT as needed. 17. Provides medical input to ensure adequate REMS. 18. Deputizes for BSL as required and if applicable. 19. Assists in training of new hires (e.g. PVEs and PVLs) as required. 20. Responsible for medical input into IB, CDS, SCS and CO, if applicable. 21. Responsible for input into RAP, MAP, and ICF. 22. Contributes to PIP. 23. Responsible for review of study protocols (including MRC or OPRC if applicable). 24. Responsible for preparation of safety issues to Novartis Boards or external meetings. 25. Provides support for licensing activities, regulatory authority inspections and for project/product recall activities, as needed. Ihr Profil • MD • At least 5-7 years of experience in Global Drug Safety (preferably Big Pharma) • Broad experience in safety regulations and requirements; desirably knowledge of trials in oncology • Good writing skills (aggregated safety reports etc.) • Leadership (leading international cross functional teams); preferable candidates who worked as well already in other areas outside of Safety before (eg, Clinical, Medical affairs etc.)… Wir bieten We offer salary structures that are tailored to the various professions and qualifications and professional experience rewarded. In addition to the interesting benefits of an expanding company we offer you the opportunity to grow through interesting and challenging projects on new challenges. In combination with the support of training you are both professionally and personally grow beyond themselves in a position in the coming years. By realizes global exchan

Angestelltenname: Aleksandra Vasiljevic

Arbeitgeber-Adresse:
Aleksandra Vasiljevic Leutschenbachstr. 95 8050 Zürich

Form von Kontakt: Aleksandra Vasiljevic

Arbeitgeber Telefonnummer: +41 445 42 30 77

Stellenkurzbeschreibung: Ärzte

Land: Schweiz

Region: Zürich

Vertragslaufzeit: Unbefristet

Vertragstyp: Vollzeit

Erforderliche Ausbildung: Uni/HS

Erfahrung: 5 Jahre und mehr

Quelle des Stellenangebots:
SECO,Öffentliche Arbeitsverwaltungen, Schweiz (Confoederatio Helvetica)

Fahrerlaubnis: Nein

Wie Sie sich bewerben: Bewerbung + Lebenslauf an den Arbeitgeber

Gehalt Währung: CHF

Gehaltsperiode: Gehalt Periode nicht spezifiziert

Gehalt Besteuerung: brutto