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Global Pharmacovigilance Specialist
1 week ago
Job Responsibilities
In this role, you will be responsible for:
- Conducting case triage and accurately entering case data into the database.
- Performing MedDRA and WHO Drug Dictionary coding of all cases.
- Writing case narratives, establishing listedness and causality assessments.
- Communicating with relevant stakeholders for follow-up information.
- Contributing to maintaining a strong medical device adverse event case handling process.
- Performing SAE reconciliation with data management/CROs.
- Acting as the Global Safety Operations trial representative.
- Performing data validation of all cases according to source data.
- Ensuring deviations and CAPAs are followed up on and closed in a timely manner.
- Establishing communication with the PV organization internally and worldwide.
- Evaluating AEs and OEs received from customer/product complaints.
Requirements
To succeed in this role, you will need:
- A university degree in health or life science with a minimum 2 years of experience in Pharmacovigilance and/or Safety Data Management.
- Strong computer literacy and knowledge of safety databases.
- Understanding of EMA/ICH/FDA guidelines.
- Ability to analyze and interpret data.
- High level of accuracy, integrity, and quality in work practices.
- Excellent communication skills, both oral and written.
