UK - Senior Drug Safety and Risk Management Specialist

A major biotechnology company, with an extensive pipeline and commercial portfolio in oncology and immunology, currently has an exciting new job opportunity for a Senior Drug Safety and Risk Management Specialist to join their UK-based team. This is an excellent opportunity to join an innovative company that delivers life-changing drugs with over 4,000 employees in over 50 countries worldwide.

Job Responsibilities:

• Tracking and (re) registration of all pharmacies administering RMP associated products, communicating efficiently and effectively with Local Service Providers to ensure compliance to RMP.
• Comply to the conditions of the Marketing Authorisation of Products through preparation, planning and the implementation of RMP in accordance with local and international legislation and the agreed timelines
• Set-up and implementation of measures to assess the compliance rate and effectiveness of the RMP.
• Consolidation and review of pharmacy audit data including Prescription Authorisation Forms (PAFs)/Audit Forms/Order Forms to be presented within a report for submission to the MHRA and IMB.
• Responsible for applying measures to ensure the validity of audit data.
• Preparation and review of RMP documentation including SOPs/WPs and RMP reports.
• Effectively liaising with the regulatory department and MHRA and IMB to ensure regulatory compliance.
• Effectively liaising with the Patient Access Scheme administrators to address RMP deviations.
• Preparation, review and distribution of RMP materials in accordance with EU GDSRM. SAE/AE Case Processing.
• To ensure the accurate, timely and complete receipt, evaluation and follow- up of domestic adverse event reports.
• To maintain the local archive of safety reports.
• To maintain current awareness of local and global safety regulations.
• To ensure compliance with local expedited and periodic regulatory reporting requirements for marketed products and those under development, utilizing ARISg and E2B.
• To contribute to the development and maintenance of corporate policies, standard operating procedures and associated documents on safety data handling Pharmacovigilance.
• To maintain current awareness of the safety profile of the development and/or marketed company portfolio and their most relevant competitors.
• To maintain current awareness of the current product labeling on all products (IB, National, SPC, Core label, US PI) Internal affiliate development.
• To assist with training of the affiliate organisation and associated third parties on safety data reporting requirements and Risk Management Plans.
• To provide advice on pharmacovigilance issues to other internal departments, or regional project teams.
• To prepare/review/present pharmacovigilance documentation for internal and external customers and to represent the affiliate Drug Safety and Risk Management Department on a company level under the supervision of the Drug Safety and Risk Management Manager.
• To mentor and develop more junior colleagues, ensuring development of the Drug Safety and Risk Management function to add value to the affiliate organization.
• Uphold and promote the company externally by demonstrating high professional standards and integrity in all external contacts.
• Enhancing the Risk Management Plan to add value to the affiliate organization.

Skills and Requirements:

• Life science/Pharmacy degree or Registered Nurse.
• Ability to lead projects under the supervision of the Drug Safety Associate Manager.
• Ability to follow standard operating procedures.
• Minimum of 4 years relevant experience within a Pharmaceutical company or CRO Leadership.
• 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 Ronni Hartgen at +44 2038000814 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.

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