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Drug Safey Manager (m/w/d)
Wien |
Permanent
Job title: Drug Safey Manager (m/w/d)
Duration of employment: Unlimited
Industry: PharmaSkills: Drug Safety / Pharmacovigilance, Pharma, PSUR Verantwortung
Ideal starting date: as soon as possible
Location: Wien
Tasks:
- Create and maintain pharmacovigilance-relevant documents on time
- Compile and control Periodic Safety Update Reports (PSUR)
- Implement and coordinate all pharmacovigilance processes in accordance with the regulatory requirements and applicable SOPs
- Manage creation and update of Risk Management Plans (RMPs) as well as implementation of additional Risk Minimization Measures (aRMMs)
- Carry out signal management tasks and lead Safety Review Meetings (SRMs)
- Ensure the compliance of our partners and act as their contact person
- Support the planning and implementation of PV audits
- Compile and process incoming safety case reports (ICSR) in cooperation with medical experts
Qualifications:
- Completed scientific studies/ technical college degree
- Several years of experience in the field of pharmacovigilance / drug safety
- Stress-resistant personality with accuracy in documentation
- Strong communication skills in English and German
- In-depth knowledge of the relevant laws and regulatory requirements for pharmacovigilance
- IT skills (Office 365, Adobe Acrobat)
Referenznummer:
Branche:
Beginn des Projekts:
Dauer:
Anstellungsart:
Kontakt
Marco Bannier
13192
Pharma
14.06.2023
n. A.
Permanent
