
Data Entry Specialist
6 days ago
Data Entry Specialist
Job SummaryWe are seeking a skilled Data Entry Specialist to join our team. As a key member of our team, you will be responsible for receiving, processing, and entering local safety case data, quality control tracking, and ICSR follow-up for all safety information received from clients within agreed timelines.
Your responsibilities will include:
- Receiving and processing safety case data
- Entering data into our safety database
- Conducting quality control checks on entered data
- Following up with clients on ICSR requests
- Responding to queries from clients
- Participating in audits/inspections and resulting action plans
To be successful in this role, you will need:
- Bachelor's or Master's degrees in Medicine, Pharmacy, Nursing, or science-related fields, or equivalent experience
- 2+ years of experience in pharmacovigilance working for service providers performing data entry and QC of cases
- Previous experience working to deadlines
- Client communications
- Knowledge of US and EU PV regulations
- Pharmaceutical background with a strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety
- Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment
The ideal candidate will possess:
- Excellent organizational and interpersonal skills
- Ability to work well within a team
- Excellent time management skills
- Accountability and autonomy with assigned tasks
- Process-oriented with good attention to detail
- Effective communication skills both written and verbal to explain complex concepts and address queries from the team
- Flexibility and adaptability to handle a dynamic workload
- Works well under pressure and meeting deadlines
- Safety database experience
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