Safety Data Specialist
7 days ago
We are seeking skilled professionals to play a crucial role in ensuring the safety and quality of our products. As a key member of our pharmacovigilance team, you will perform local safety case receipt, processing and data entry, quality control tracking and ICSR follow up of all safety information received for our clients.
Responsibilities:- Perform daily tasks including local safety case receipt, processing and data entry, quality control tracking and ICSR follow up of all safety information received for our clients.
- Manage generic or client-specific email boxes as required.
- Register, triage, assign and coordinate vigilance cases for processing.
- Follow up on requests with local reporters.
- Respond to queries from clients and reporters.
- Conduct periodic reconciliations to confirm proper handling of vigilance reports for our clients.
- Bachelor's or Master's degree in Medicine, Pharmacy, nursing, or a science-related field.
- At least 2 years' experience in pharmacovigilance, including data entry and QC of cases.
- Proven ability to work under pressure and meet deadlines.
- Strong understanding of US and EU PV regulations.
- Knowledge of GVP, GCP, FDA and regulatory requirements related to drug safety.
- Excellent organizational, interpersonal and time management skills.
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