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Pharmacovigilance Manager
AOP Orphan Pharmaceuticals AG
Arbeitsort
Wilhelminenstraße 91/IIf, 1160 Vienna, Österreich
Wilhelminenstraße 91/IIf, 1160 Vienna, Österreich
Art des Arbeitsverhältnisses
Vollzeitbeschäftigung
Vollzeitbeschäftigung
Gehalt (brutto)
3500 EUR/Monat
3500 EUR/Monat
Informationen über die Arbeitstelle
Arbeitsinhalt, Befugnisse und Verantwortlichkeiten
Pharmacovigilance Manager (f/m)
with staff management responsibility
In this central role you are responsible for the management of the pharmacovigilance system which includes authorized and developmental products. The holder of the position acts as a line manager for the employees of the Pharmacovigilance Group.
Responsibilities in detail:
• Administration of the complete Pharmacovigilance documentation (all drug-safety relevant documentation for registered and drugs in development)
• Assessment and processing of incoming adverse reaction reports in cooperation with the QPPV and the medical expert
• Compiling case narratives and CIOMS form for SAE and ADR cases
• Reporting of safety reports to the authorities, ethics committees and contract partners Compiling of development safety update reports, periodic safety update reports, risk management plans, line listings
• Screening of literature with the focus on identification of relevant case reports
• Ensuring compliance of the PV system with all applicable rules and regulations (laws, guidelines, regulations)
• Preparation and review of SOPs related to pharmacovigilance
• Setting up and management of PV agreements, partners and vendor management
• Knowledge of legal basis of PV (GVP, other relevant European and national guidelines, Austrian drug law)
• To keep internal and external communication
• Regular training of AOP staff on pharmacovigilance
• Conduct of PV audits (incl. external partners)
• Support of the QPPV and responsibility for the pharmacovigilance system in cooperation with the QPPV and back-up in case of absence of the QPPV: subsequent takeover of the QPPV responsibility possible
• Leadership and managing (direct reports) responsibility for the Pharmacovigilance Group members
with staff management responsibility
In this central role you are responsible for the management of the pharmacovigilance system which includes authorized and developmental products. The holder of the position acts as a line manager for the employees of the Pharmacovigilance Group.
Responsibilities in detail:
• Administration of the complete Pharmacovigilance documentation (all drug-safety relevant documentation for registered and drugs in development)
• Assessment and processing of incoming adverse reaction reports in cooperation with the QPPV and the medical expert
• Compiling case narratives and CIOMS form for SAE and ADR cases
• Reporting of safety reports to the authorities, ethics committees and contract partners Compiling of development safety update reports, periodic safety update reports, risk management plans, line listings
• Screening of literature with the focus on identification of relevant case reports
• Ensuring compliance of the PV system with all applicable rules and regulations (laws, guidelines, regulations)
• Preparation and review of SOPs related to pharmacovigilance
• Setting up and management of PV agreements, partners and vendor management
• Knowledge of legal basis of PV (GVP, other relevant European and national guidelines, Austrian drug law)
• To keep internal and external communication
• Regular training of AOP staff on pharmacovigilance
• Conduct of PV audits (incl. external partners)
• Support of the QPPV and responsibility for the pharmacovigilance system in cooperation with the QPPV and back-up in case of absence of the QPPV: subsequent takeover of the QPPV responsibility possible
• Leadership and managing (direct reports) responsibility for the Pharmacovigilance Group members
Anforderungen an den Mitarbeiter
Für die Stelle sind Bewerber mit der Ausbildung geeignet
Universitätsausbildung (z. B. Bc., ...)
Universitätsausbildung (z.B. Dipl. Ing., ...)
Doktorat
Universitätsausbildung (z.B. Dipl. Ing., ...)
Doktorat
Sprachkenntnisse
Deutsche Sprache - Obere Mittelstufe (B2) und Englische Sprache - Obere Mittelstufe (B2)
Andere Kenntnisse
Microsoft Word - Fortgeschrittene
Microsoft Excel - Fortgeschrittene
Microsoft Excel - Fortgeschrittene
Anzahl der Jahre der Berufspraxis
3
Charaktervoraussetzungen und Fähigkeiten
Job Requirements
• Degree in natural sciences
• At least 3 years experience in the pharmaceutical industry in the relevant function (clinical studies, post-marketing)
• Previous experience in project and/or people management
• Training and experience in EudraVigilance (would be an asset) and with case processing in conventional databases
• Good understanding of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements
• Fluency in English as business language
• IT skills: at least medium proficiency in MS office and major databases
• High sense of responsibility, good organizational and time management skills
• Excellent interpersonal skills, teamplayer
• Excellent verbal & written communication skills
• Attention to detail, pragmatic and solutions driven
• Leadership experience and qualification
Place of employment – Vienna, Austria.
A very versatile job with a high degree of independence and responsibility in a successful international team awaits you.
The gross monthly salary provided for this function is a minimum of € 3.500, based on full-time employment. Any potential overpayment depends on professional experience and qualification.
If you think you are the right candidate and are interested in this challenging job in a professional team, then please send your application papers to:
Alexandra Lange
AOP Orphan Pharmaceuticals AG
Wilhelminenstraße 91/II f, 1160 Wien
Tel.: 01/503 72 44-942, Fax: 01/503 72 44-61
e-mail: [email protected]
• Degree in natural sciences
• At least 3 years experience in the pharmaceutical industry in the relevant function (clinical studies, post-marketing)
• Previous experience in project and/or people management
• Training and experience in EudraVigilance (would be an asset) and with case processing in conventional databases
• Good understanding of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements
• Fluency in English as business language
• IT skills: at least medium proficiency in MS office and major databases
• High sense of responsibility, good organizational and time management skills
• Excellent interpersonal skills, teamplayer
• Excellent verbal & written communication skills
• Attention to detail, pragmatic and solutions driven
• Leadership experience and qualification
Place of employment – Vienna, Austria.
A very versatile job with a high degree of independence and responsibility in a successful international team awaits you.
The gross monthly salary provided for this function is a minimum of € 3.500, based on full-time employment. Any potential overpayment depends on professional experience and qualification.
If you think you are the right candidate and are interested in this challenging job in a professional team, then please send your application papers to:
Alexandra Lange
AOP Orphan Pharmaceuticals AG
Wilhelminenstraße 91/II f, 1160 Wien
Tel.: 01/503 72 44-942, Fax: 01/503 72 44-61
e-mail: [email protected]
Inserierende Gesellschaft
Kurze Charakteristik der Gesellschaft
AOP Orphan specializes in the research of rare disorders. It develops, produces and markets innovative solutions designed to combat them, making it the European pioneer in the field of orphan diseases. The Vienna-based company is dedicated to developing personalized treatments for sufferers of rare conditions.
Anzahl der Mitarbeiter
150-199 Mitarbeiter
ID: 1720903
Datum zveřejnění: 23.4.2014
2014-04-23
lokalita: Österreich Pozice: Pharmacovigilance Spezialist (m/w) Společnost: AOP Orphan Pharmaceuticals AG
Základní složka mzdy (brutto) a další odměny: 3500 EUR/Monat