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Job Descrption

Our clientis a global biopharmaceutical company manufacturing plasma-derived, and recombination therapeutic products, who in turn deliver high-quality medicines that treat people with rare and serious diseases, and we are now searching on an exclusive basis with the client to appoint aRegional Safety Officer to join their busy and rewarding team on a contractual basis for a period of 12-Months.

Responsibilities:
The Regional Safety Officer (RSO) is responsible for ensuring, in sync with commercial objectives, consistency and compliance of Regional PV activities in line with Seqirus standards and regulatory requirements. In addition, it is responsible for initiating and execution of ODCS programs and ensuring the safety obligations within Social and Digital media platforms within the Region.

The RSO will lead and oversee the country-specific PV activities in accordance with the global and local PV requirements, internal Seqirus procedures.

This position requires collaboration with... cross functions such as Commercial, Regulatory Affairs, Medical Affairs, Quality, Global Pharmacovigilance Agreements and Alliance team, EU QPPV and local QPPVs.

Requirements:
• Higher education degree in a scientific field
• 5+ years’ experience in pharmaceutical industry, preferably within pharmacovigilance department.
• Experience with PVA negotiations, ODCS process and execution
• Expertise in EU and international PV regulations
• Negotiate the responsibilities of each party within the pharmacovigilance agreements (PVAs) and ensure that all the PVAs within European regions are on track.
• Manage the PVA/PV clause workflow within the CSL global platforms as per the company SOPs
• Support the implementation of PVAs/PV clauses in close collaboration with the responsible functions.

If this role is of interest to you, please apply now!#LI-KT1

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