Drug Safety Associate

Highly Competitive
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United Kingdom
Maidenhead, Berkshire
Posting date: 12 Jun 2019

An internationally known biotechnology company has an opening for a position as a Drug Safety Specialist with their office in Maidenhead. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide. This vacancy is an exciting opportunity to work with this leading organisation and bolster a career in the field of Drug Safety.

Job Responsibilities:

  • Overseeing the overall provision of safety report handling relating to the company.
  • Developing and maintaining local PV processes and procedures.
  • Training and tracking all external providers on appropriate PV-related procedures.
  • Reviewing local and national legislation (MHRA or HPRA) to maintain an awareness of local regulations and ensuring local processes are aligned with these requirements.
  • Notifying Global Drug Safety (SABR) of any programmes/contractual arrangements with external providers with significance for handling AE information.
  • Notifying SABR of changes in personnel with direct responsibility for handling safety information.
  • Reviewing external provider reports for AEs and PCs.
  • Tracking safety reports from a variety of sources within specified timelines.
  • Reviewing local literature for safety-related content.
  • Maintaining oversight of outsourced vendors with PV responsibilities.
  • Serving as the PV contact for local staff and SABR.
  • Assisting SABR with regulatory requests or audits/inspections.
  • Providing SABR with monthly reports on PV metrics.
  • Being a Qualified Trainer for safety database for PV staff.
  • Case processing for PML cases and following up on PML cases.
  • Overseeing PV Operations Vendor's compliance and follow-up activities.
  • Reviewing local market research material for compliance with legislation and codes of practice.
  • Reviewing vendor contracts for appropriate safety wording.
  • Tracking safety data exchange agreements.
  • Assisting with audits/monitoring visits of external third-party vendors.
  • Being responsible for PV oversight for Company's patient support programmes and homecare.
  • Assisting SABR with late case investigations.
  • Overseeing PV-related CAPA/Exception management.
  • Providing scientific Product Therapy Support for internal and external stakeholders.
  • Assisting with the collection and reporting of all adverse events/product complaints as defined both by internal SOPs and UK/Irish regulations
  • Tracking and coordinating training for appointed PSP vendor and internal training on PSP activities.
  • Managing documents for PSP - related documentation working in conjunction with marketing teams.

Skills and Requirements:

  • A university degree in a relevant subject.
  • Demonstrable experience in a similar or related capacity.
  • Minimum of 5 years of industry PV industry experience.
  • Knowledge of local regulations.
  • Significant experience of working in an affiliate environment.
  • Experience of working with homecare companies and patient support programmes.
  • Process driven with ability to set work systems, procedures and track performance.
  • Understanding of commercial business needs and strategy.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Divya Mistry at +44 20 3814 1315 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.