Senior Pharmacovigilance Quality Specialist

Job Description

*Senior Pharmacovigilance Quality Specialist - Global BioPharma - 12-month contract - OUTSIDE - UK REMOTE* My client is a Global Biopharmaceutical company and they have a position available for a Senior Pharmacovigilance Quality Specialist for an initial 12- month contract (Outside of IR35).Within this role Senior PV Quality Specialist is responsible for fully participating, contributing to and leading activities that include the collection, analysis and reporting of Safety Risk Management and 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. The Senior PV Quality Specialist will provide support and guidance to other PV Quality Management colleagues. Main Responsibilities: Deviation and CAPA support PV System compliance monitoring, metrics and trending Audits & Inspections Procedural Document support In order to apply for the Senior Pharmacovigilance Quality Specialist contract, you should possess: Bachelors Degree in a life sciences or healthcare related discipline Experience in pharmacovigilance with experience in quality related activities. Experience of data collection, management, reporting, or auditing Knowledge of CAPA processes required and experience of managing CAPA related activities. Good knowledge of key GVP regulatory requirements, in particular those relating to quality and quality management systems. 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. Ability to manage, assess and visualise compliance, performance or PV-related data relevant to the assigned activities (e.g. assess adverse event data / clinical information) Ability to process and manipulate data, analyse information effectively and reporting information to stakeholders and business leaders in ways that facilitate decisions and the creation of knowledge Excellent oral and written communication skills Well organised, with attention to detail Ability to work independently, often simultaneously working on several projects at the same time. Good stakeholder management and the ability to effectively collaborate across a global organisation. Enthusiastic and self-motivated. Ability to influence other stakeholders within the function. Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK. This role can be remote working based in the UK.To apply for this position or if you want to discuss other roles that we are working on, please do not hesitate to contact Roberta Atkins on . Required skills

CAPA

Pharmaceutical

Pharmacovigilance

PV

Quality

QMS

Contract

Pharma

GVP

PV Processes

outside IR35

WIs

Procedural documents

Keyskills :
CAPA Pharmaceutical Pharmacovigilance PV Quality QMS Contract Pharma GVP PV Processes outside IR35 WIs Procedural documents