Regional Pharmacovigilance Officer - Remote

Job Title: PV Regions Operations Specialist

Location: Remote UK

Contract: 12 months Hours: 37.5 p/w

Salary: inside IR35 via Umbrella

Please note: this role does not offer any VISA sponsorship, to be eligible for the role you must have the right to work in the UK. If you are interested in finding out more about this role or others, please contact Manpreet Bhullar at mbhullar@i-pharmconsulting.com or call +44020 7551 0802.

i-pharm consulting is working with one of the largest biotechnology companies. For over a century, they have been an unstoppable force, from developing medicines that save and improve lives to vaccines that protect them. Today, with the combined expertise their various entities and their singular commitment to relentlessly innovate- their offerings are more diverse than ever to help ensure patients and people everywhere get the treatments they deserve and are looking for a PV Regions Operations Specialist to join them on a 12-month contract at their offices in Maidenhead, UK.

Description:

The Regional Safety Officer (RSO) is responsible for ensuring, in sync with commercial objectives, consistency and compliance of Regional PV activities in line with 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 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.

Responsibilities:

• Support the European Region under the leadership of the Region's Territory Managers and Heads.
• Support development and implementation of Local PV systems in the European Region, in line with companies' policies, SOPs and with the regulatory requirements.
• Coordinate with cross functions and ensure that information relating to new business alliances, special imports, PVAs, ODCS, Social and Digital media programs is captured and communicated to relevant functions, and PV obligations are met for commercial initiatives.
• Ensure robust flow of information (adverse events, safety information, PSURs etc.) from the Seqirus local commercial affiliates, external service providers/distributors and internal GCSP functions (i.e case management, QPPV team).
• Maintain the PV information regarding European countries within relevant Region's platforms.
• 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 global platforms as per the company SOPs.
• Support the implementation of PVAs/PV clauses in close collaboration with the responsible functions.
• Ensure adequate arrangements for safety data collection are in place for ODCS and Digital media activities initiated or managed by Seqirus.
• Manage ODCS and Digital media programs within the global platform as per the company SOPs.
• Support the PV training of ODCS vendors, external service providers/distributors, as required.
• Perform impact assessment of local PV regulatory intelligence in the dedicated platform(s).
• Monitor the Seqirus PV Regions mailbox, as required.
• Support audits and inspections within European regions, as required

Requirements:

• Bachelor's degree (e.g., in quality, life-sciences, nursing, medical writing, documentation) OR equivalent 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