Deputy Drug Safety Officer

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Municipality
Leiden
Education
HBO
Hours per week
40 hours
Contract type
Tijdelijk met uitzicht op vast
Salary indication
€4500-6500
Vacancy number
#1AV0022720

About the job

About the job

Are you fulltime availaible and do you have and experience as a Drug Safety Officer? Then is this vacancy definitely something for you!

Act as the local deputy Drug Safety Officer (DSO) managing its related duties and act as a contact person for any safety issues at the responsible country and/or Affiliate.

Management of Product Safety Information (PSI):

  • Lead and, if applicable, provide effective management of PSI. Ensure that safety information (Adverse Events) received from all sources by the Affiliate are collected, translated and forwarded to designated Regional PV HQ, in compliance with required timelines (reporting timelines), quality guidelines and standards. If applicable: Timely ICRS submissions to the Competent Authority
  • Ensure that the PV Case Tracking System, PV Register, is used to accurately capture PSI, and to be responsible for ensuring that the PV Register is maintained in real-time.
  • Be responsible for monitoring caseload trends to ensure sufficient resources are allocated to manage fluctuating PV caseload. Be responsible for monitoring interactions with vendors that are used to conduct PV services

PV Quality and Compliance:

  • Ensure of the company affiliate is GPvP inspection and audit ready and support a PV audit or inspection if needed
  • Ensure filing, storage and archiving of PV documentation in accordance with PV regulations and with Astellas policies and procedures
  • Manage and coordinate all PV activities in alignment with regulatory requirements and internal Astellas procedures to ensure full compliance with regulatory requirements.
  • Implementation of relevant updates to PV regulations (including maintenance reporting rules matrix), within the required timeline. Communicate any changes to PV Affiliate Support Function, EU-QPPV, the GPV Regional HQ Office and/or other local business functions, as applicable.
  • Accountable for ensuring compliance with local and regional PV regulations and Astellas policies/procedures and take corrective and/or preventive actions, as appropriate and required.

Maintenance of PV System and Oversight Responsibilities:

  • Provide input for the PSMF regarding the Affiliate communication to GPV Regional HQ
  • Responsible and accountable for PV self-assessments, PV audits/inspections at the Affiliate and assist in developing CAPAs (with qualitative/quantative measures and timelines) in response to findings/observations
  • Ensure that qualification of PV vendors is conducted, and periodic audits are requested, if applicable.
  • Manage outsourced partners to ensure PV activities are conducted according to the relevant procedures
  • Provide support to establish contracts with Vendors and License Partners: subject to language ability.
  • Responsible for the Quality Management System (QMS), including QA and QC activities
  • Accountable and responsible for the development and maintenance of locally applicable PV Quality documents.
  • Request to have access to, and be aware of, the Affiliate business continuity plan (for example system failure and other disasters) in relation to PV activities.
  • Accountable for ensuring a local mechanism is in place for 24/7 availability to enable appropriate handling of potential urgent safety issues by the affiliate.
  • Ensure oversight and monitoring of all local studies and projects, including digital media and Astellas sponsored websites that impacts PV.
  • Support in the development of safety monitoring and reporting plans for clinical trials that impact the affiliate. Ensure local post-marketing programs (e.g. Post Authorization Studies [PAS], Post Authorization Programs [PAP] or market research, post marketing surveillance [PMS]) protocols are reviewed for compliance with PV requirements, as applicable.
  • Ensure that changes of Affiliate PV and/or Business Partners are communicated to the PV Affiliate Support Function
  • Participate in local activities concerning Risk Management Plans and Risk Minimization Measures
  • Act as the safety expert for the update of SmPCs/PILs

Relationship management:

  • Serve as a point of contact for the PV Regional HQ functions, PV Affiliate Support Function, the Affiliate MT and M&D functions.
  • EMEA only: Liaise with the EU-QPPV (periodic and ad-hoc) through PV Affiliate Support

What we offer

  • Full time job (40 hours);
  • Project for 7/8 months, with possible extension;
  • Good salary (4500-6500)
  • Good communication skills.
  • Able to read and speak in English
  • You are living in the Netherlands (MUST)

Job requirements

  • Management of Product Safety Information (PSI)
  • PV Quality and Compliance
  • Maintenance of PV System and Oversight Responsibilities
  • Relationship management
  • Good communication skills.
  • Able to read and speak in English
  • Full time available
  • You live in the Netherlands

About the company

The company is a multinational pharmaceutical company employing over 17,000 people worldwide.
The philosphy of the company is the following: Contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.

Our hope is to change tomorrow.

The company is based in Leiden. It's easy to reach with the car and they have free parking. Also you can go with the public transport from Leiden, Den Haag, Rotterdam and Amsterdam (Schiphol).

Job information

Unique Uitzendbureau Leiden

Schipholweg 55
2316 ZL Leiden

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