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Patient Safety Manager (interim)

For our pharmaceutical client, we are looking for an interim Patient Safety Manager.
This is a 6-month assignment.

Responsibilities:
Maintain expert knowledge of local pharmacovigilance regulations.
Communicate impact of changes in
local pharmacovigilance regulatory requirements to Patient Safety.
Support the communication of safety related issues and information that may be of relevance to the identification of potential safety signals to Patient Safety / EU QPPV and local stakeholders.

Act as a back-up point of contact with the local Regulatory Authority for:
Management of safety related queries
Submission of PBRERs/PSURs, RMPs and Risk Minimisation Activities and safety signals
Pharmacovigilance inspections

Maintain expert local knowledge and oversight of:
the safety profile of locally marketed products and any emerging safety concerns
local studies and solicited programmes ongoing in the region and local post approval commitments
local licensing agreements (if applicable)
Provide input to ensure the appropriate development and revision of local benefit / risk documentation and RMPs and risk-minimization activities
Ensure a proactive and strategic approach to PV locally through partnership with the leadership team and business partners e.g., awareness and input into new product launches and oversight of local solicited programs, providing support and review of contracts

to ensure alignment with global standards
Utilize and proactively participate in the Affiliate Patient Safety Network and access available Patient Safety resources such as the Agreement Repository, Patient Safety Shared drive and the Patient Safety SharePoint to ensure access to current information, including global PV Agreements, PBRERs/PSURs, RMPs and the Pharmacovigilance System Master File

Fulfil back-up local legal PV responsible role

The ideal candidate will possess:
Scientific background along with a medical-scientific university degree e.g., Life Science or Pharmacy
Drug safety experience in the post-marketing environment
Comprehensive knowledge of global safety regulatory requirements and extensive knowledge of safety regulations and Good Pharmacovigilance Practices pertaining to the EU

Knowledge of local healthcare systems to enable input into local benefit / risk decisions and local Risk Management (RMPs)
Effective communicator (written and oral); concise, accurate and business appropriate
Proven ability to work cross-functionally
Demonstrates teamwork and initiative
Excellent attention to detail and be able to demonstrate and deliver high-quality work

Location

Amsterdam (hybride)

Publication date

24.09.2024

Contact person

Pieter Suyk
More information
Pieter Suyk

E-mail:
pieter@nexusls.nl

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Nexus Life Sciences is the only recruitment agency in the Netherlands, that focuses solely on connecting specialists, managers and companies in the pharmaceutical industry

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