Category

Description

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.

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