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Pharmacovigilance Manager (gn) (DE)

[11466]
Pharma, Drug Safety / Pharmacovigilance, PV System

Positionstitel: Pharmacovigilance Manager (gn) Anstellungsdauer: unbefristet Branche: Pharma Fähigkeiten: Pharma, Drug Safety / Pharmacovigilance, PV System Idealer Startzeitpunkt: 17.05.2022 Einsatzort: Frankfurt Aufgaben: ·Oversee adherence to the global guiding principles to harmonize the processes of local PV system file (or similar concepts) maintenance by the relevant company affiliates worldwide as applicable. Oversee the maintenance of local PV system files by the relevant local teams ·Support Global QPPV Office in the management of the Pharmacovigilance System Master Files (PSMFs) ·Support the Global QPPV and the relevant Global PV organisation to maintain a framework for Local Person responsible for Pharmacovigilance (LPPV) collaboration and alignment ·Work with Global QPPV to improve overview of the Global PV system ·Support any other initiatives by Global QPPV office and Global Pharmacovigilance team ·Manage all routine activities and the Global QPPV office mailbox in collaboration with the relevant Global QPPV office team members ·Partner with stakeholders across multiple functional lines globally to ensure high quality contributions delivered in a timely manner ·Collaborate with stakeholders in relevant continuous improvement activities Qualifikationen: ·Bachelor’s or Master’s degree in biological sciences ·Several years of demonstrated experience in pharmacovigilance or clinical safety; experience with project management preferred ·Excellent verbal and writing skills in English with experience in writing, editing and compiling regulatory documents ·Strong collaborator and contributor to the leadership of projects, initiatives, or programs across multiple departments, regions, business units and external stakeholders ·Experience in coordinating, assembling and editing large, complex documents with multiple contributors with the following tools/systems: document management, records management, data visualization ·Understanding of the processes associated with Pharmacovigilance and Regulatory or Clinical Development ·Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Teams, MS PowerPoint, Visio, etc.) ·Strong team player, with first rate communication and organisational skills, adherence to timelines and the ability to deal with multiple tasks at the same time ·Able to work independently within a global team environment ·You have a proactive approach ·Travel to other European and International locations as required for the role

Positionstitel: Pharmacovigilance Manager (gn)
Anstellungsdauer: unbefristet
Branche: Pharma
Fähigkeiten: Pharma, Drug Safety / Pharmacovigilance, PV System
Idealer Startzeitpunkt: 17.05.2022
Einsatzort: Frankfurt

Aufgaben:
  • Oversee adherence to the global guiding principles to harmonize the processes of local PV system file (or similar concepts) maintenance by the relevant company affiliates worldwide as applicable. Oversee the maintenance of local PV system files by the relevant local teams
  • Support Global QPPV Office in the management of the Pharmacovigilance System Master Files (PSMFs)
  • Support the Global QPPV and the relevant Global PV organisation to maintain a framework for Local Person responsible for Pharmacovigilance (LPPV) collaboration and alignment
  • Work with Global QPPV to improve overview of the Global PV system
  • Support any other initiatives by Global QPPV office and Global Pharmacovigilance team
  • Manage all routine activities and the Global QPPV office mailbox in collaboration with the relevant Global QPPV office team members
  • Partner with stakeholders across multiple functional lines globally to ensure high quality contributions delivered in a timely manner
  • Collaborate with stakeholders in relevant continuous improvement activities



Qualifikationen:
  • Bachelor’s or Master’s degree in biological sciences
  • Several years of demonstrated experience in pharmacovigilance or clinical safety; experience with project management preferred
  • Excellent verbal and writing skills in English with experience in writing, editing and compiling regulatory documents
  • Strong collaborator and contributor to the leadership of projects, initiatives, or programs across multiple departments, regions, business units and external stakeholders
  • Experience in coordinating, assembling and editing large, complex documents with multiple contributors with the following tools/systems: document management, records management, data visualization
  • Understanding of the processes associated with Pharmacovigilance and Regulatory or Clinical Development
  • Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Teams, MS PowerPoint, Visio, etc.)
  • Strong team player, with first rate communication and organisational skills, adherence to timelines and the ability to deal with multiple tasks at the same time
  • Able to work independently within a global team environment
  • You have a proactive approach
  • Travel to other European and International locations as required for the role




map Frankfurt date_range 17.05.2022 update Permanent
Direct contact

Marco Bannier

Associate Senior Consultant
mail m.bannier@aristo-group.com
phone +49 89 599 1827 200


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