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Job Details

Lead Quality Specialist - Pharmacovigilance

Company: CROMSOURCE
Location: United Kingdom
Reference: HQ00001430
Closing Date: 21 Aug 18
Type: Contract
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

Job Title: Lead Quality Specialist - Pharmacovigilance   Location: Greater London, United Kingdom       TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions is currently recruiting for a Lead Quality Specialist - Pharmacovigilance to strengthen the team of one of our clients, a leading pharma company. This is a 12 months contract.

Requirements:

Job Title: Lead Quality Specialist - Pharmacovigilance

Location: Greater London, United Kingdom

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions iscurrently recruiting for a Lead Quality Specialist - Pharmacovigilance to strengthen the team of one of our clients, a leading pharma company. This is a 12 months contract.

The Lead Quality Specialist - Pharmacovigilance will be accountable for leading activities relating to the end-to-end management of process deficiencies and non-compliances identified for processes owned by the Pharmacovigilance System, including activities to accurately investigate and determine underlying and systemic root causes, design and ensure implementation of effective corrective and preventive measures to deliver continuous improvements.

In addition, responsibilities may include supporting activities relating to the conduct of Pharmacovigilance and Good Clinical Practice Safety audits and inspections and leading other aspects of Pharmacovigilance system related Quality Management System activities.

The Lead Quality Specialist - Pharmacovigilance will provide leadership and guidance to other Pharmacovigilance Quality Management & Analysis colleagues.

Responsibilities:

  • Takes the defined role of Global Process Quality Responsible for the management of deviations and audit/inspection findings.
  • Works in close collaboration with Global Process Owners and wider stakeholders within and outside of the department to effectively deliver results for the CAPA process.
  • Accountable for key activities including: assessment and categorization of deviations for criticality, identification and management of a Core Team to support management of the CAPA, leading Root Cause Analysis activities, drafting CAPA plan and effectiveness measures, overseeing CAPA plan implementation and performing effectiveness changes, identification and escalation of issues if timelines may be at risk.
  • Performs trend analysis on deviation/finding data, with input from functional Subject Matter Experts, in collaboration with the GPO
  • Support Health Authority Inspections as required in collaboration with Core Inspection Team specifically in the area of document request management.
  • Assist and participate in Pharmacovigilance Inspection Readiness activities.
  • Support in preparation and conduct of internal process audits.
  • Maintains a cross-functional network with other Global Process Quality Responsible and Subject Matter Expertss that support or interface their assigned GVP/GCP process(es).
  • Provides advice on their assigned GVP/GCP process(es) to other Global Process Quality Responsible and Affiliates, as requested.
  • Ensures customer feedback is gathered, evaluated for performance improvement

Education and Experience:

  • Bachelor's degree or equivalent in life sciences or healthcare field.
  • Extensive experience in the pharmacovigilance or clinical safety related area with experience in quality related activities
  • Experience of data collection, management, reporting, or auditing is desired
  • Strong experience in design and management of CAPA is required.
  • Strong knowledge of key GVP regulatory requirements

If you would like to be considered for this exciting opportunity please send your CV in WORD directly to https://www.cromsource.com/careers/send-your-cv/

Why TalentSource Life Sciences/CROMSOURCE

CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.

To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.

Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.

Keywords: Pharmacovigilance, Lead, PV, Drug Safety, CRO, Outsourced, Contract, ICSR, Individual Case Safety Report, Safety, Temporary, , Risk Management, Freelance, CAPA, Safety Audit, QMS, PV systems, Clinical Safety

Pharmacovigilance

Apply for this job: Lead Quality Specialist - Pharmacovigilance

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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