Senior PV Manager – Procedures, Policies and Training

Responsibilities:

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.

Senior PV Manager