Berufsbezeichnung: DRUG SAFETY LEAD

Arbeitsbeschreibung:
YOUR TASKS _ We are currently looking for an experienced Drug Safety (DS) Lead to ensure ICH/FDA/EMA guideline compliance of company drug safety. In this role, you will be responsible for the following tasks: Responsible to organize the exchange of all safety relevant information between the Drug Safety Department Vifor Pharma and involved CROs for all clinical trials Responsible for the review/preparation of individual safety reports (SUSARs) and reports of aggregated clinical data (Annual Safety Reports/Developmental Safety Update Reports) according to legally required timelines to Health Authorities, Ethical Committees and external Safety Review Boards Answering medical safety queries related to case management Maintaining in-house medical safety knowledge about the product and its benefit-risk profile Signal detection and benefit-risk assessment Weekly review of scientific literature published on safety and efficacy of the product Safety input into product regulatory, labelling, medical, clinical activities Liaison with the HAs related to safety enquiries Review and input into signal assessment, all aggregate safety reports, risk management plan Creation and maintenance of procedural documentations related to the above activities YOUR PROFILE _ For this important role we are looking for an experienced DS professional with a high level of education in life sciences (PhD), preferably a qualified Medical Doctor. You bring the following profile: Experience in International Drug Safety, ideally operational as well as clinical drug safety Experience in data analysis, signal detection and benefit/risk evaluation Excellent knowledge of international regulations (ICH, GVP, Volume 10, FDA regulations) Fluency in English Experience in Pharmaceutical Medicine, particularly Clinical Research, and/or experience in Clinical Pharmacology would be an asset Knowledge and experience in Pharmacoepidemiology Demonstrated ability to set up and implement drug safety strategies, risk management plans, develop drug dafety systems and procedures, and elevate and resolve issues Demonstrated proficiency in problem-solving with respect to pharmaceutical drug safety issues Good computer literacy with experience with safety data bases (ARISg preferably) We are looking for a hands-on person with the ability to communicate with different levels of professionals and stakeholders. You are able to prioritize even under pressure and you feel comfortable working in a multicultural team.

Angestelltenname: Vifor Pharma

Arbeitgeber-Adresse: Vifor Pharma Flughofstrasse 61 8152 Glattbrugg

Form von Kontakt: Lucie Kulhanek

Arbeitgeber Telefonnummer: +41 58 851 83 68

Stellenkurzbeschreibung: Biotechniker (ohne medizinische Fachberufe)

Land: Schweiz

Region: Zürich

Vertragslaufzeit: Unbefristet

Vertragstyp: Vollzeit

Erforderliche Ausbildung: Keine Angabe

Erfahrung: siehe Beschreibung

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

Fahrerlaubnis: Nein

Wie Sie sich bewerben: Weitere Angaben (siehe Beschreibung)

Gehalt Währung: CHF

Gehaltsperiode: Gehalt Periode nicht spezifiziert

Gehalt Besteuerung: brutto