Reference Number: JO-2003-447210
Global PV Compliance Lead
Rate: Negotiable
Job Type: Permanent
Location: Chertsey

Global PV Compliance Lead
Competitive Salary
Benefits: Up to 15% bonus, pension, private healthcare

Clinical Professionals are excited to have partnered with a rapidly growing, global pharmaceutical company based in Buckinghamshire. Their focus is the development and commercialisation of drugs for the treatment of patients with unmet therapeutic needs.

There is currently a new opportunity for a senior PV expert to join the business as a Global Compliance Process Lead on a permanent basis. This is a pivotal role in which you will have responsibility for the maintenance and development of PV compliance processes including documentation, templates, systems, policies and training. This is a role for an established Pharmacovigilance professional with demonstrable experience of implementing and managing PV compliance processes within a global pharma or CRO.

Key Responsibilities:
– Report directly to the Global Head of PV Compliance
– Establish, develop and implement document management plans
– Ensures that organizational documents go through a documented and approved
review-and-approval process before being stored
– Serve as a strategic thought partner to the Global Head of PV Compliance with
regard to the future strategies of PV document management
– Maintain internal expertise in quality system documentation, including (technical &
operational): SOPs, WIs, Manuals, Specifications (SRS, URS, SCS), Qualification
documents (vendor, or system IQ, OQ, PQ), Safety Management Plans, Safety
reporting plans, Safety Data Management Plans,

Candidate Requirements:
– Demonstrable experience of implementing PV document management systems
– Subject Matter Expert within PV Compliance
– Experience of rolling out cross-functional PV compliance training
– Proven track record of leadership, accountability and willingness to confront
complex problems
– Strong written and verbal communication skills

If you are interested and you believe you have the relevant experience for this role, please send your cv to george@clinicalprofessionals.co.uk or call 0118 959 4990 for further info.

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