Job Reference: J5632090
Updated On: 04/09/2019
Status: Now Interviewing
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Role OverviewWe are currently looking for a Pharmacovigilance Team Leader to join a leading Consultancy company based in the Hertfordshire area. As the Pharmacovigilance Team Leader you will be responsible for the Clinical Trials team where you will project manage Clinical Trial studies and delegate work to the team, ensuring they maintain compliant with Pharmacovigilance legislation.
Key Duties and ResponsibilitiesYour duties as the Pharmacovigilance Team Leader will be varied however the key duties and responsibilities are as follows:
1. Project Manage Pharmacovigilance Clinical Trial Studies from Study set up including Study Management plans and creation of Pharmacovigilance Agreement.
2. Manage SAE (Serious Adverse Event) and SUSAR (Suspected Unexpected Serious Adverse Reaction) workflow and submission including reconciliation processes.
3. Preparation, review and submission of Development Safety Update Reports (DSURs).
4. Manage Client interactions as well as lead a team of Pharmacovigilance professions including distribution of work.
Role RequirementsTo be successful in your application to this exciting opportunity as the Pharmacovigilance Team Leader we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline or relevant Pharmacovigilance experience
2. Proven industry experience in a Pharmacovigilance setting where you have focused on Clinical Trial reporting. This includes Case reporting, Triage and QC of reports.
3. A working knowledge and practical experience with SAE and SUSAR workflow as well as exposure to DSURs
Key Words: Pharmacovigilance | Drug Safety | Team Leader | Manager | Clinical Trials | SAE | SUSAR | DSURs | Client Management | Project Management
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