Data Officer (Clinical Safety) Job at ProductLife Group. Apply Now !
Are you passionate about clinical safety and pharmacovigilance? Do you have a keen eye for detail and a strong understanding of regulatory compliance in the pharmaceutical industry? PLG is looking for a dedicated Data Officer (Clinical Safety) to join our team and play a crucial role in ensuring accurate safety data management.
As a Data Officer (Clinical Safety), you will work closely with our Pharmacovigilance (PV) and Clinical teams, contributing to the monitoring, processing, and reporting of adverse events, serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs). Your expertise in pharmacovigilance, drug safety databases, and regulatory reporting will help maintain compliance with global safety regulations, ultimately supporting patient safety and regulatory excellence.
If you have experience in drug safety data entry, regulatory documentation, and pharmacovigilance tools, this position offers an exciting opportunity to be at the forefront of pharmaceutical safety and compliance. Join PLG and be a part of a team that is committed to ensuring the highest standards in clinical safety!
Job Posting: Data Officer (Clinical Safety)
Responsibilities
- Processing of Adverse Events (AEs) / Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)
- Query preparation, sending, and follow-up
- Maintenance of study trackers and other relevant tools
- Reconciliation of clinical safety information/activities with Customer/CRO/Data Management
- Assisting in aggregate periodic safety reports preparation
- Assisting in expedited and periodic safety reports submissions
Education
- Scientist, PharmD
- Experience in Pharmacovigilance/Drug Safety Data Entry
- Knowledge of databases (Safety database: SafetyEasy)
- Knowledge of drugs and pharmaceutical environment
- Knowledge of Pharmacovigilance/Drug Safety regulation (national and international) and Pharmacovigilance tools
- Specific trainings in Pharmacovigilance/Drug Safety
- Knowledge of the Customer’s products and services
Skills
- Attention to detail
- Organisation
- Critical Thinking
- Effective Communication
- Time and Priorities management
- Team Spirit
Keywords: Data Officer, Clinical Safety, PV, Pharmacovigilance, Drug Safety, Safety Data Entry, Compliance, Regulatory Standards
