Berufsbezeichnung: Brand Safety Leader (w/m)

Arbeitsbeschreibung:
You looking for a challenge as a Brand Safety Leader? Then support us with your expertise at our location in Switzerland. Ihre Aufgabe 1. Responsible for safety issue management from end of Phase I (POC) through Life Cycle Management. 2. Accountable for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, postmarketing data, and other sources. 3. Accountable for developing and updating, at milestones, the safety profiling and risk management plan from end of Phase I (POC) through Life Cycle Management, as relevant. Accountable to ensure adequate risk management plans are in place. 4. Leads Safety Management Team. 5. Serves as safety representative as core member of Global Program Teams. Manages Drug Safety Monitoring Board activities for assigned projects/products, as required. 6. Accountable for responses to inquiries from regulatory authorities or health care professionals on safety issues. Accountable for safety data for health authority review boards. Accountable for responses to legal queries and CPO requests involving safety issues. Ensures safety information communicated to EU Qualified Person in a timely fashion. Co-ordinates product-specific activities. 7. Accountable for integrated safety input into all safety relevant parts of regulatory and company documents (ie IB, CDS, SCS, RMP, SPP, CO, PIP, GDPS, CDP, etc) required during active development, submission phase and during marketing phase. 8. Review of medical safety input into study protocols (including MRC and OPCE), MAP, RAP, and ICF. 9. Review/approve product-specific safety deliverables: IN letter, PGD, data searches, literature review, expert statements. 10. Co-ordinates involvement of external experts (e.g. authors of “white papers”, members of trial-specific data safety monitoring boards, ad-hoc support for HA meetings, etc.) 11. Accountable for presentations on project/product safety issues to internal Novartis Boards, or expert panels and other meetings. 12. Collaborates productively and manages in a cross-functional matrix team environment (e.g. SMT). 13. Assist in training of new hires (e.g. new BSLs) and mentor/coach direct reports (PVL/PVE) as required. 14. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities. 15. Serves as and performs activities of Pharmacovigilance Leader such as ad hoc medical case review 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 exchange with the Brunel employees to benefit long-term from different knowledge and experience. Have we piqued your interest? Then please apply via our online form. We look forward to meeting you! Über Brunel The best experts, the most demanding projects, the largest industrial diversity - that's Brunel. As one of the most successful international engineering and HR services we offer top projects in leading companies. Over 13,000 specialists worldwide for Brunel International NV to 100 locations in 40 countries successfully. Weitere

Angestelltenname: Aleksandra Vasiljevic

Arbeitgeber-Adresse:
Aleksandra Vasiljevic Leutschenbachstr. 95 8050 Zürich

Form von Kontakt: Aleksandra Vasiljevic

Arbeitgeber Telefonnummer: +41 44 542 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

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