I am working with a global pharmaceutical company in Hertfordshire who is looking for a Senior Pharmacovigilance Quality Specialist to join their team on a 12-month contract.
The Senior PV Quality Specialist is responsible for fully participating, contributing to and leading activities that include the collection, analysis and reporting of PDS & PV quality and compliance data to ensure adherence to internal/external standards and regulatory requirements. Responsibilities also include PV/GCP Safety Inspection & Audit support, providing support for Deviations and Corrective Actions/ Preventive, and supporting or leading aspects of procedural document management and other PV QMS activities.
Some of your responsibilities will include:
●Deviation and CAPA support:
oAssists Global Process Quality Responsibles (QRs) in activities relating to the investigation of deviations/findings and the development and oversight of corrective and preventative action plans in response to audit or inspection findings, or in response to internally identified trends in errors or other non-compliance
oSupport the PDS organization to identify data trends or process deficiencies, ensures that deviations are appropriately reported and ensure PV process improvements are suggested and implemented to prevent non-compliance.
●PV System compliance monitoring, metrics and trending:
oLead the collation of quality and compliance metrics for all PV processes, review of data for accuracy and escalation of any issues/trends to management
oProduction of PV System Compliance reports and supporting materials
oProduction of Annex F of the Pharmacovigilance System Master File PSMF for PV system compliance
●Audits & Inspections:
oSupport Health Authority Inspections as required in collaboration with Core Inspection Team specifically in the area of document request management.
oAssist and participate in PV Inspection Readiness activities.
●Procedural Document support:
oAlign and collaborate with other PDS sub-functions to maintain PDS processes and standards globally, ensuring that PDS activities meet all regulatory requirements and guidelines and comply with Company policies and procedures.
Skill and Qualifications:
*Bachelor's Degree (preferably in a life sciences or healthcare related discipline)
*Experience in pharmacovigilance or clinical safety related area with experience in quality related activities.
*The capability to utilize various quality management/analysis methodologies, used by the business (ideally with qualifications indicating proficiency in relevant techniques).
*Experience of data collection, management, reporting, or auditing is an advantage
*Knowledge of CAPA processes required and experience of managing CAPA related activities desired.
*Good knowledge of key GVP regulatory requirements, in particular those relating to quality and quality management systems. Good understanding/experience in one or more specific area of GVP or Clinical Trial safety
*Ability to manage, assess and visualize compliance, performance or PV-related data relevant to the assigned activities (e.g. assess adverse event data / clinical information)
*Good stakeholder management and the ability to effectively collaborate across a global organization.
If you are interested in discussing this position further then please send your CV to Sabrina Deo at firstname.lastname@example.org
You must be eligible to work in the UK. Learn more
- Agency: Paramount Recruitment
- Reference: sd-pvquality
Website: Paramount Recruitment
- Posted: 30th April 2021
- Expires: 14th May 2021