The Drug Safety Associate will be responsible for tasks related to Pharmacovigilance, including assisting the Qualified Person for Pharmacovigilance (QPPV), global literature monitoring, data entry and quality review, signal detection and evaluation, and preparation of regulatory documents.
Key Responsibilities:
- Detailed knowledge about current global pharmacovigilance guidelines and procedures.
- Prioritize cases according to day zero and seriousness, ensuring cases are completed within the timelines mentioned in client SOP.
- Verify the accuracy of data captured by case registration/import associate.
- Perform duplicate checks during case processing to identify any inconsistency.
- Download literature reports, line listings, and process these cases.
- Review and assess the validity of literature abstracts and articles, processing them into the safety database if required.
- Download Individual Case Study Reports (ICSR), line listings, and process these cases.
- Perform MedDRA coding.
- Monitor Pharmacovigilance Risk Assessment Committee (PRAC) recommendations and update accordingly.
- Manage worldwide scientific literature, including screening and processing literature reports.
- Ensure compliance with database usage through the latest SOPs and relevant manuals.
- Maintain compliance with regulatory and local/global SOP timelines through proactive workflow management.
- Represent Drug Safety in regulatory and internal inspections and audits as required.
Qualifications:
- Doctor in Pharmacy (Pharm D).
- Skills in Narrative, Medical Coding, and Pharmacy.
- Excellent attention to detail.
- Knowledge of pharmacovigilance regulations and requirements.
- Strong written and verbal communication skills.
- Experience in Pharmacovigilance or a related role is a plus
