Junior Patient Safety Lead (m/w/d)

in temporary employment.

Our client is a global player in the pharmaceutical industry. As a research-based company with a long tradition, our client has a worldwide presence. With more than thousand employees, the German site also plays an important role.
For the next possible date we are looking for a motivated personality as a

Junior Patient Safety Lead (m/w/d)

in temporary employment.

  • Bereich:

    Medical

  • Berufssparte:

    Pharmacovigilance

  • Arbeitsregion:

    Berlin

  • Art der Anstellung:

    Interim

  • Kennziffer:

    26522

  • Aktualisierung:

    25.03.2021

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Your tasks

  • Manage the PV relationship within the local operating company (LOC) to provide best PV support for the LOC.
  • Supports LOCs within their Cluster, where applicable
  • Collaborate and liaise with PVAR and other GPSE functions to ensure appropriate systems/processes are in place to support the local PV system
  • Provide Pharmacovigilance functional expertise and support to LOCs
  • In partnership with PVAR defines and implements the local PV strategies as appropriate
  • Coordinates PV system in the LOC which can include but is not limited to compliance to all applicable Global PV processes, commercial team engagements; PSP, MR, suppliers with PV obligations, agreements, PV training, supplier issues etc. This includes working with PV suppliers where appropriate and ensuring a common understanding of the distribution of PV responsibilities is in place.
  • Works closely with the regional PVAR Liaison to support and facilitate LOC PV interactions with other sub-functions of GPSE and with other LOCs within the Cluster, where applicable.
  • Works with PVAR to implement global, regional and local and cluster wide (where applicable) PV strategies at the LOC
  • Maintains appropriate stakeholder network with applicable Commercial BU, LOC and R&D to facilitate implementation of GPSE strategy and serve as a liaison in their assigned territory to prevent gaps between Commercial BU, R&D functions and GPSE.
  • To be the SME (subject matter expert) of their assigned territory as it relates to applicable global, regional and local regulatory requirements, resourcing, compliance and other factors.
  • Support local and/or regional PV suppliers (e.g. local resident QPPV suppliers, PV services suppliers (incl. for business continuity) as required including establishing appropriate oversight of such suppliers.
  • Support LOCs within assigned cluster (where applicable) in collaboration and agreement with the appointed cluster lead.
  • Supports local QPPV and/or local PV contact person activities where required and trained to do so
  • Line manage PV resources if applicable
  • Supports maintenance of Descriptions of Pharmacovigilance Responsibilities (DPRs) to provide official record of GPSE and LOC delegation of responsibilities.
  • Works with Cluster Leads, Process and Compliance leads, Vendor Management/Oversight personnel in support of LOC PV audits/inspections including follow-up and CAPA management.
  • Ensure close collaboration with GPSE Process and Compliance leads in ensuring QA and compliance disciplines, globally, regionally and locally to best support LOC needs.
  • Ensures all contact information and any changes of LOC PV personnel are maintained for GPV communications.

Your qualifications

  • Health professional or life science degree and a minimum of 2 years of experience in the area of pharmacovigilance
  • Bachelor is required or a proven track record to have worked at an equivalent degree. Advanced degree preferred.
  • Relevant pharmaceutical or health care related industry experience required
  • Meets all applicable local PV requirements including education, training, experience.
  • Relevant experience in PV related environments, preferably at local, regional and/or global levels
  • Relevant experience of working cross-functionally
  • Understanding of medical/scientific terminology
  • Good knowledge of PV regulations for the post marketing global environment and applicable legislation
  • Good written/oral communication skills (German and English) and experience working within virtual teams
  • Accuracy and attention to detail
  • Flexible mindset
  • High degree of cross-cultural awareness
  • Team worker with collaborative approach.
  • Ability to prioritise under pressure
  • Well-developed organizational skills
  • High standard of computer literacy

Ihre Ansprechpartnerin

Bettina Cöppicus
Senior Personalberaterin

Anschrift

Optares ICM GmbH & Co. KG
Bettina Cöppicus
Heiligengeist Höfe 8
26121 Oldenburg