- Our company is one of the world’s most successful pharmaceutical companies with a great growth potential.
- Do you want to be part of this?
- Safety Operations is part of Global Safety who has the global responsibility for surveillance of the Safety and Quality of our company clinical development and marketed products.
- Safety Operations is responsible for global handling and reporting of adverse event reports.
As a Drug Safety Associate you will be part of a young and dynamic team currently consisting of 63 dedicated employees.
- Perform initial evaluation of reported adverse events (serious and non-serious) from all sources.
- Perform case entry and verification of reported non-serious and serious adverse events; enter the reported information in the company safety database, on the basis of individual case histories, correspondence with affiliates/sites and other departments in headquarters (HQ) and various administrative assignments.
- Ensure accurate and consistent coding of all events for serious and non-serious cases entered in the Argus with the use of MedDRA (Medical Dictionary for Regulatory Activities).
- Evaluate causality, seriousness and listedness for all cases.
- Ensure that case narrative comprises correct and appropriate safety information.
- Assess the need for follow up information and issue follow up requests for all cases and post queries in EDC and/or to affiliate
- To be responsible for Periodic Safety Update Report (PSUR) clean up and other case clean-up activities.
- Ensure that all tasks are performed in compliance in accordance to GXP requirements.
- Maintain a network of safety contacts within Global Safety (GS) and affiliates.
- Participate in projects in Global Safety or in other parts of the organisation with impact in Global Safety processes.
- Liaise with affiliates and partners for local literature and compliance.
- Liaise with Safety Reporting and IT in all aspects of data retrieval and custom reporting.
- Participate in inspections and audits when required.
- Assist with related administrative and procedural activities as required or requested.
- Independent decisions making regarding evaluating the submission of adverse event reports.
- Ensure compliance with the training plan provided for the role.
- Act as a buddy for colleagues and provide training as required
- We also expect you to take an active part in the continuous development of the growing department.
Typical knowledge and specific experience
- Good communication skills (written and oral), with English correspondence.
- Basic working knowledge of MS Windows applications including MS Office tools.
- Basic knowledge of Pharmacovigilance and medicinal terminologies and Clinical Pharmacology.
- Basic knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety.
- Basic organizational or pharmaceutical company understanding.
- Basic knowledge of company products, incl. mechanism of action, safety profile, patient population, etc
- Self-motivated and proactive.
- Quick learning and analytical skills.
- Ability to take up initiatives.
- Team oriented personality with high degree of flexibility.
- Ability to capture attention and motivate a team around discussion.
- Ability to work independently and within strict timelines.
- Attention to detail and quality.
- Willingness to occasionally work at unusual times.
- Strive for continuous improvement.