Achieva Group Ltd

Senior Pharmacovigilance Scientist

Location
Hertfordshire
Salary
£37 - £45 per hour
Posted
16 Apr 2021
Closes
16 May 2021
Ref
BH-25616
Contact
Sophie Fosh
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
Our global pharmaceutical client has a vacancy for a Senior PV Scientist.
 
Our client is looking for candidates based in the UK.
 
This is an initial 12-month full time contract.
 
 
Purpose:
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.
Primary Responsibilities and Accountabilities
●     Deviation and CAPA support
●     PV System compliance monitoring, metrics and trending
  • Lead the collation of quality and compliance metrics for all PV processes, review of data for accuracy and escalation of any issues/trends to management
  • Production of PV System Compliance reports and supporting materials
●     Audits & Inspections
  • Support Health Authority Inspections as required in collaboration with Core Inspection Team specifically in the area of document request management.
●     Procedural Document support
Education/Qualifications
 
Minimum:
●        Bachelor's Degree (preferably in a life sciences or healthcare related discipline)
●        Typically 5+ years’ experience in pharmacovigilance or clinical safety related area with experience in quality related activities.
 
Strongly desired:
●        Higher degree in a relevant discipline
●        The capability to utilize various quality management/analysis methodologies, used by the business (ideally with qualifications indicating proficiency in relevant techniques).
 
Experience, Skills, Knowledge:
●        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
●        A solid understanding of the key principles of good process design which embed quality and efficiency and enable effective measurement of performance.
●        Ability to effectively map out simple processes and analyse existing simple processes to identify areas of weakness and suggest improvements.
 

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