Drug Safety Lead, Germany

Drug Safety Lead, Germany

Seagen

Munich, Germany

Summary:

Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to three marketed products, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information about Seagen can be found at www.seagen.com

This position in Munich, Germany describes the responsibilities of a local safety officer and Stufenplanbeauftragte/-r for Germany and Austria as well as the deputy for Switzerland.

Responsibilities:

  • Serving as GPO (Stufenplanbeauftragte/-r) and LSO according to German law (including but not limited to responsible for establishing and maintaining the Seagen’s pharmacovigilance system in Germany, ensuring compliance with local pharmacovigilance legislation and responsible for evaluating product defects and managing recalls)
  • Serving as the Seagen LSO for Austria
  • Be the connection between the EU QPPV, the EU QPPV office, and the German office responsible for the local activities in both Germany and Austria.
  • Serving as the Seagen deputy LSO for Switzerland

Safety case management and reporting:

  • Has oversight on spontaneous, literature and solicited AE cases as assessed and submitted according to global SOPs.
  • Performs local literature screening
  • Ensures oversight of local vendors performing drug safety activities

Local PV system and legislation:

  • Assures compliance with global and local SOPs and WIs.
  • Incorporates the global PV system in the local organization and provides input to the global system
  • Where relevant drafts and maintains local SOPs and WIs
  • Ensures adequate PV training of the local organization
  • Acts as internal contact point for PV
  • Acts as an external point of contact for the local HA for local interactions related to patient safety/ public health for the local market.
  • Creates and implements local PV business continuity plans (e.g., inspection readiness, AE reporting coverage).
  • Ensures awareness of changes in regulations which may have an impact on PV activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups
  • Provides guidance to local and global on the interpretation of local PV regulation.
  • Leads and brings to resolution with all appropriate functional groups, locally and globally, all product safety related issues that arise in the country
  • Acts as local subject matter expert (SME) for risk management (RM). Leading local implementation of Risk Minimization measures, in compliance with RMPs.
  • Ensures local audit and inspection readiness at all times
  • Ensures, facilitates and participates in PV related audits and inspections.
  • Performing root cause analysis of deviations relevant to the local PV processes
  • Oversees the development, implementation and execution of any necessary local CAPA plans.
  • Ensures local implementation of Pharmacovigilance/Safety Data exchange Agreements or appropriate PV language for all relevant third-party agreements. Assure proper implementation at local level of those with PV implications; in addition, ensure that these contracts are archived in the global system, as applicable.
  • Maintains a close connection with the local organization including but not limited to Medical Affairs, Business Quality, Business Intelligence, Clinical and Marketing and Sales. Participate in local projects, leadership meetings as appropriate.
  • Assures a close relationship with regional and global management
  • Takes on additional responsibilities on request of Head of GSRM/QPPV

Qualifications:

  • At least 3 years’ experience working in Pharmacovigilance (pharmacovigilance experience in the respective country preferably). Prior experience in EU pharmacovigilance, Regulatory, Clinical, or Medical Information in pharmaceutical Industry will be considered as an advantage
  • Qualified as Stufenplanbeauftragte/-r
  • Subject matter expert in local, regional and any other relevant legislation related to pharmacovigilance

Education:

  • Degree in health or life science or nursing qualification

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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