Drug Safety and Risk Management Specialist

A multinational pharmaceutical company that specialises in oncology and inflammatory disease is seeking a Drug Safety and Risk Management Specialist to join their team in Hayes, UK on a contract basis.

Job Role:

• To execute and support all local safety-related activities as directed by the UK and Ireland Head of Drug Safety.
• Ensure compliance with local and international regulations and company internal standards
• 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.
• To assist the UK and Ireland Head of Drug Safety by accurately and thoroughly training and mentoring junior members of staff to ensure compliance within the Drug Safety Department in the affiliate
• To represent the Drug Safety Department within the affiliate as a point of reference internally Role and Responsibilities: 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 Risk Management
• Comply 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.
• Support implementing measures to assess the compliance rate and effectiveness of the PPP.
• Quality review of electronic Risk Management Programme system data output against paper PAFs.
• Assist Preparation, review and distribution of PPP materials in accordance with GDSRM-EMEA/APAC.
• 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
• To assist with training of the affiliate organisation and associated third parties on safety data reporting requirements
• To capture, follow-up and ensure the appropriate persons are notified of locally reported Product Quality Complaints.
• To mentor and develop more junior colleagues, driving development of the drug safety function to add value to the affiliate organisation

Education, Skills and 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
• Excellent written and verbal communication skills
• Previous relevant experience within a Pharmaceutical company or CRO Leadership Competencies (Behaviours)

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 call Zico Dervish on +44 203 319 3031 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.