Highly Skilled Case Specialist
1 day ago
As a highly skilled Case Specialist, you will play a vital role in contributing to the activities performed in our dynamic environment. This includes ensuring data accuracy through data entry of vigilance cases into relevant databases, performing quality control checks on vigilance cases and associated safety reports, conducting medical reviews of vigilance cases according to regulatory requirements, following up on vigilance cases via phone and mail, analyzing complex cases before data entry, identifying submission requirements for safety cases, reviewing and analyzing ICSRs downloaded from competent authorities databases, reconciling partner, medical information, and quality complaints data, participating in the operational implementation of new projects, and serving as a key contact for projects with support from team leaders.
Key Responsibilities:
- Perform medical reviews of post-marketing cases as assigned.
- Lead operations for assigned post-marketing clients.
- Draft and update technical agreements, safety management plans, and client templates.
- Develop SOPs, WPDs, trainings, and other documents related to the activity.
- Collaborate in process implementation, maintenance, and improvement.
Requirements:
- Pharmacist or Life Sciences degree with over 3 years of experience in PV.
- Proven ability to work under deadlines.
- Strong pharmaceutical background, understanding GVP, GCP, FDA, and regulatory requirements.
- Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.
Education and Experience
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