Drug Safety and Risk Management Specialist | 12 month contract

Drug Safety and Risk Management Specialist | 12 month contract

This is a great opportunity for a Drug Safety Specialist to join a global pharmaceutical company to work on both pre-and post-market activities in clinical trials. To be successful in this role, you will need to have prior experience in both pharmacovigilance case processing and reporting. Utilising skills in risk management plans and regulations including FDA, EMA and ICH.

As a Drug Safety Specialist within this innovative organisation, you will be delivering risk management plans, writing reports and liaising with the MHRA and HPRA. Located on the outskirts of West London you will be part of a team of pharmacovigilance specialists, working on clinical trials and ensuring regulatory reporting compliance.

KEY RESPONSIBILITIES:

• SAE case processing and evaluation
• Review data including prescription authorisation forms for report submissions
• Develop risk management process and documentation such as SOPs
• Utilise ARISg and E2B to ensure regulatory compliance for marketed products
• Submissions of RMPs to the relevant authorities

REQUIREMENTS:

• Life science/Pharmacy degree ideally
• Previous relevant experience
• Excellent attention to detail and ability to ensure documents are properly filed and stored
• Ability to work independent and as a part of the team
• Strong communication skills

Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.