- Good knowledge of PV related regulations
- Acts as a subject matter expert for APVC
- Hybrid
My client is seeking a Manager, Affiliate PV Coordination.
The post holder will be responsible for the maintenance and creation of departmental procedures including, but not limited to, Standard Operating Procedures (SOPs, as applicable) as well as ensuring that the EU affiliates are supported in the performance of pharmacovigilance activities according to SOPs and the regulatory and global requirements.
KEY RESPONSIBILITIES
- Provides support for APVC activities
- Addresses or coordinates PV-related issues with relevant global or local functions for a resolution
- Organizes and supports periodic or ad hoc trainings or meetings with local and global PV
- Supports global PV teams to implement new procedures, systems and requirements
- Supports establishment of a compliant PV system in the affiliates
- Monitors and supports local PV system improvement in the affiliates
- Oversees applicable written PV procedures in the affiliates
- Reviews and provides PV-relevant inputs for GSOPs from the LSMs/ LPPV/LPVCP perspective
- Acts as a subject matter expert for APVC related subjects as applicable, in PV related regulatory inspections or quality assurance / corporate compliance audits and supports with deviations and CAPAs, as required
- Ensures work is properly documented and filed
- Supports, reviews and QC's assigned PSMF Annexes, as applicable
- Acts as a liaison internally and with external pharmacovigilance service providers and business partners on drug safety and PV issues, as assigned by PV management
QUALIFICATIONS/ EXPERIENCE REQUIRED
- Education in healthcare of life sciences (e.g. biological sciences, pharmacy, nursing, physician assistants, nurse practitioners) preferably at bachelor level (or comparable local degree) or higher
- Minimum 3 years' experience in PV or PV-related area in the pharmaceutical industry or Health Authority
- Experience of CAPAs, and Vendor Management
- Speak and write English to a good standard with familiarity of English medical terms
- Good knowledge of PV related regulations