Senior PV Manager

Posted 09 March 2023
Job type Permanent
Contact NameHannah Hollamby

Job description

Senior PV Manager – Procedures, Policies and Training

  • Develop, implement and maintain SOPs, work instructions, templates, forms, and business practice tools.
  • Manage the Global Patient Safety procedural portfolio to ensure the PV system complies with global safety regulations for clinical trial and post marketing
  • Drive standardisation across Global Patient Safety processes and training; support procedural document implementation
  • Establish and manage training programmes in collaboration with SMEs
  • Create and maintain training materials with SME input/support as needed
  • Deliver pharmacovigilance training to stakeholders
  • Manage Adverse Event training for employees, contractors and vendors
  • Monitor training compliance for Global Patient Safety and vendors providing safety services in partnership with Global Patient Safety and other SMEs; manage training compliance metrics
  • Generate, contribute to, and manage departmental metrics
  • Archive procedural and training documentation including individuals’ compliance with training
  • Monitor Global Patient Safety regulations globally for changes and collaborate with SMEs to update procedures as necessary
  • Provide input on PV requirements (e.g., reporting, training, archiving records, etc.) for contracts
  • Collaborate with and/or manage PV vendors with respect to procedural and training aspects to support Global Patient Safety activities and deliverables.
  • Manage initiatives and projects as requested to continuously enhance the effectiveness and efficiency of Global Patient Safety processes and training

Qualifications and Experience:
  • Bachelor’s degree in healthcare or life sciences; An advanced degree such as PharmD, RN or BSN is preferred.
  • Considerable experience in a global Pharmacovigilance/Drug Safety department is required.
  • Solid experience of managing people.
  • Must have strong knowledge of global Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
  • Proven project management experience. Experience managing vendors is desirable.
  • Proven track record of forging relationships to promote collaboration and driving successful projects.
  • Ability to influence others.
  • Strong organizational skills and writing skills. Attention to detail and accuracy of work.
  • Excellent communication skills (written and verbal) and ability to work with people in all levels of the organization and externally.
  • Ability to effectively manage multiple priorities with a sense of urgency. Strategic thinker, ability to problem-solve and make decisions.
  • Self-motivated with the ability to work effectively and independently in a dynamic environment with ambiguity
  • Must possess strong knowledge of pharmacovigilance regulations and guidelines (EMA, MHRA, FDA, PMDA, ICH).
  • Excellent knowledge of Microsoft Office (Word, Excel, PowerPoint).
  • Advanced experience analyzing data in Excel (e.g., pivot tables) and utilizing PowerPoint is highly preferred.