Drug Safety & Risk Management Specialist - 12 month contract - United Kingdom
- Our company is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives.
- Our purpose as a company is to discover and develop therapies that will change the course of human health.
- We value our passion for patients, quest for innovation, spirit of independence and love of challenge.
- With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
- To assist with delivery of ongoing activities and enhancing the Risk Management Plan for the company's products.
- To execute and support all local Risk Management (RM) related activities as directed by the UK and Ireland Head of Drug Safety and Risk Management.
- Ensure compliance with local and international regulations and company’s internal standards
- To contribute effectively as part of the company Global Drug Safety and Risk Management network
- To represent the Drug Safety and Risk Management Department within the affiliate as a point of reference internally for Drug Safety and Risk Management queries, under the supervision of the Drug Safety and Risk Management Manager
- To oversee and execute timely local case-processing activities, including ensuring robust investigation and follow-up of local safety reports for both marketed products and those under development
- To oversee and execute timely and accurate reporting to the National Competent Authorities.
Role ResponsibilitiesRisk Management:
- Tracking and (re) registration of all pharmacies administering the Pregnancy Prevention Plan (PPP) as part of the RMP associated company products, communicating efficiently and effectively with Local Service Providers to ensure compliance to company RMP.
- Comply to the conditions of the Marketing Authorization of company Products through preparation, planning and the implementation of Our company PPP in accordance with local and international legislation and the agreed timelines.
- Set-up and implement measures to assess the compliance rate and effectiveness of the PPP.
- 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 HPRA.
- Applying measures to ensure the validity of audit data.
- Preparation and review of RM processes and documentation including SOPs/WPs and PPP periodic reports.
- Effectively liaising with the regulatory and compliance department and MHRA and HPRA, as directed by the UK and Ireland Head of Drug Safety and Risk Management, to ensure regulatory compliance
- Effectively liaising with the Patient Access Scheme administrators to address PPP deviations.
- Preparation, review and distribution of PPP materials in accordance with GDSRM-EMEA/APAC.
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.
Internal affiliate development:
- To assist with training of the affiliate organisation and associated third parties on safety data reporting requirements and Risk Management Plans including the PPP.
- To capture, follow-up and ensure the appropriate persons within company are notified of locally reported Product Quality Complaints
- Enhancing the Risk Management Plan and the PPP to add value to the affiliate organization.
QualificationsQualifications / Skills / Experience
- Life science/Pharmacy degree or Registered Nurse
- Attention to detail
- Ability to follow standard operating procedures
- Be able to work independently and as part of a team
- Strong identification with company’s values
- Excellent written and verbal communication skills
- Previous relevant experience within a Pharmaceutical company