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Drug Safey Manager (m/w/d) (DE)
[13192]
Drug Safety / Pharmacovigilance, Pharma, PSUR Verantwortung
Job title: Drug Safey Manager (m/w/d) Duration of employment: Unlimited Industry: Pharma Skills: 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) · · ·
- 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
- 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)
Marco Bannier