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