
Senior Clinical Safety Specialist
1 day ago
**Job Title:** Pharmacovigilance Associate
\The purpose of this role is to monitor and manage the safety aspects of clinical studies post-marketing surveillance.
\- Describe the tasks, duties, and responsibilities the employee who is working on this role is supposed to carry out.
- Manage project-specific activities which may include preparation of safety management plan, preparing safety DB configuration documents for each project, and preparing slides for project kick-off meetings.
- Case processing activities and drafting safety narratives, monitoring of safety mailbox, filing study documents in TMF, managing unblinding procedures, conducting literature searches and monitoring for adverse event reports, and participating in clinical study reconciliation activities as requested by client.
The ideal candidate should have a good understanding of clinical trials and pharmacovigilance requirements, experience in coding medical terminologies, case processing, and safety report submission, thorough knowledge of medical terminology, strong computer proficiency, and ability to work in specific databases, fluency in written and oral English, good interpersonal skills, time management, and multitasking capabilities.
\Novotech offers a great workplace with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development programs. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
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