UK - Drug Safety and Risk Management Specialist
A global biotechnology company is advertising a vacancy for a Drug Safety and Risk Management Specialist. With an extensive pipeline and commercial portfolio in oncology and immunology, this organisation is offering an exciting opportunity to join their team in Uxbridge. The successful applicant will have the chance to marry their expertise to an internationally renowned company and support their innovative impact on the healthcare field.
- Ensuring the accurate, timely, and complete receipt, evaluation, and follow- up of domestic adverse event reports.
- Maintaining the local archive of safety reports.
- Maintaining current awareness of local and global safety regulations.
- Ensuring the compliance with local expedited and periodic regulatory reporting requirements for marketed products and those under development, utilizing ARISg, and E2B.
- Contributing to the development and maintenance of corporate policies, standard operating procedures, and associated documents on safety data, handling Risk Management.
- Complying with the conditions of the Marketing Authorisation of company Products through preparation, planning, and the implementation of company PPP in accordance with local and international legislation and the agreed timelines.
- Supporting the implementation measures to assess the compliance rate and effectiveness of the PPP.
- Quality reviewing electronic Risk Management Programme system data output against paper PAFs.
- Assisting in the preparation, review, and distribution of PPP materials in accordance with GDSRM-EMEA/APAC.
- Maintaining current awareness of the safety profile of the development and/or marketed company portfolio and their most relevant competitors.
- Maintaining current awareness of the current product labeling on all company products (IB, National, SPC, Core label, US PI) Internal affiliate development.
- Assisting with training the affiliate organisation and associated third parties on safety data reporting requirements.
- Capturing, following up on, and ensuring the appropriate persons within the company are notified of locally reported Product Quality Complaints.
- Mentoring and developing more junior colleagues, driving development of the drug safety function to add value to the affiliate organisation.
Skills and Requirements:
- Life science/Pharmacy degree or Registered Nurse.
- Ability to follow standard operating procedures.
- Previous relevant experience within a Pharmaceutical company or CRO Leadership Competencies (Behaviours).
- 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.
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 Ronni Hartgen at +44 2038000814 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.