PE Global is currently recruiting for a Pharmacovigilance Senior Manager for a 12 month contract role with a leading multinational Pharma client.
Based in Bracknell (2 days per week in the office) working 36.25 hours per week.
The pay rate is between £27.59 and £36.78 per hour PAYE
This is a fixed-term contract role providing maternity cover for the UK/IE Pharmacovigilance (PhV) Leader during a period of planned absence. The Senior Manager, UK/IE Pharmacovigilance will manage the UK/IE affiliate PhV operations, ensuring compliance with applicable company requirements and pharmacovigilance regulations.
Job Responsibilities
* Oversee UK/IE PhV daily operations (e.g. adverse event management, reconciliations and quality checks, review of proposed market research programs and local digital media, local literature screening, managing health authority interactions, signal and safety communications, risk management and periodic reporting), implementing improvements, leading corrective/preventative actions as applicable, and ensuring appropriate training of all UK/IE PhV personnel.
* Support and maintain the UK/IE PhV system, maintain local data in EU and UK PSMF, monitor the status of the quality system and pharmacovigilance activities, and sustain/promote compliance with legal requirements and relevant Good Vigilance Practices.
* Escalate safety and compliance issues to appropriate local/global management including the UK QPPV and ensure appropriate communication between UK/IE safety personnel and stakeholders (e.g. GPS, Regulatory Affairs, Medical).
* Maintain, review, and update local PhV-related SOPs, controlled documents, tools, and job aids in a timely manner, ensuring alignment with GPS documentation and local regulations, and that they are well understood by UK/IE PhV personnel.
* Provide technical expertise on the interpretation and implementation of national PhV legislation, for both drugs and devices, to the UK/IE affiliate and GPS, including monitoring UK/IE regulatory developments and changes to pharmacovigilance legislation and guidance (e.g. via MHRA and HPRA notifications), escalating to the Associate Director and supporting risk assessment and change control activities as required.
* Lead, coordinate, and organise all necessary training on adverse event reporting to GPS across all UK/IE employees.
* Provide vendor management oversight of adverse event collection activities, including those arising from digital media monitoring, market research programmes, and Patient Support Programmes (PSPs).
* Review and approve local business/safety agreements impacted by PhV regulatory requirements (e.g. Business Alliances, Patient Support Programmes, distribution agreements).
* Maintain PhV operational awareness and local oversight of UK/IE Risk Management Programme (RMP) activities and additional Risk Minimisation Measures (aRMMs), including implementation, distribution, effectiveness monitoring, and documentation in line with GVP requirements, coordinating with Global Risk Management, Regulatory Affairs, Medical, and local commercial teams and regulators as required.
* Maintain an understanding of Post-Authorisation Safety Studies (PASS) requirements and support GPS and affiliate obligations relating to PASS activities within the UK/IE market as applicable.
* Understand the UK/EU Qualified Person for Pharmacovigilance (QPPV) roles and obligations, and liaise with them accordingly for UK/IE.
* Liaise with the Local PhV Business Continuity Plan (BCP) coordinator to perform an annual PhV BCP test or invoke the PhV BCP if needed.
* Strive for inspection/audit readiness and collaborate in inspections/audits involving UK/IE affiliate PhV operations.
Requirements
* Bachelor’s degree (or higher) in physical or biological sciences (or equivalent demonstrated experience).
* Established pharmacovigilance experience.
* Understanding of EU and UK/IE PhV regulatory requirements (relevant guidelines and legislation).
* Demonstrable knowledge and experience of Risk Management Programme (RMP) activities and additional Risk Minimisation Measures (aRMMs) in a UK/IE or EU context.
* Excellent communication (written and verbal), interpersonal, organisational, and negotiation skills.
* Previous experience in managing/leading teams.
* Experience working within a global pharmaceutical company PhV function.
* Experience with MHRA and/or HPRA regulatory interactions.
* Knowledge of quality systems and audit/inspection processes.
* Project management experience.
* Familiarity with aRMM implementation and effectiveness evaluation in current UK/IE regulatory framework.
Interested candidates should submit an updated CV.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***