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- Posted 09 March 2023
- Job type Permanent
- Contact NameHannah Hollamby
Senior PV Manager – Procedures, Policies and Training
Qualifications and Experience:
- 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.