.Pharmassist Ltd is a fast-growing, full service Contract Research Organisation located in Athens, Greece and London, United Kingdom, providing services in Clinical Trials, Pharmacovigilance, Regulatory Affairs, Medical Affairs, and Quality Management.
Within an ever-increasing recruitment rate in all of our departments, we are now seeking to invest in exceptional, enthusiastic professionals, with experience and expertise in the following field:
Senior Drug Safety Officer
The ideal candidates for the position should fulfil the following qualifications/requirements:
- Life Science Bachelor’s degree or higher
- Knowledge in medical terminology
- A minimum of 3 years experience on PV activities
- Excellent written and verbal communication skills in English
- Self-motivated and able to work independently
- Effective time management skills
- Excellent knowledge of Microsoft office
- Capability to problem-solving and managing complex safety issues.
General duties include:
- Assisting with the management of safety reports including data entry, MedDRA coding, quality control and expedited report submission and tracking.
- Assist in compilation and submission of aggregate reports
- Assist the Senior team in developing metrics to monitor the performance of pharmacovigilance activities; suggest performance improvements
- Supporting the preparation of RMP and post-marketing safety monitoring activities.
- Performing the analysis of potential safety signals according to SOPs and guidelines
- Reviewing Safety Data Exchange Agreement with clients
- Maintaining the Pharmacovigilance System Master Files (PSMF) and eXtended Medicinal Product Dictionary
- Providing drug safety guidance and training to our clients’ employees
- Insuring procedures in relation to safety monitoring are being adhered to regulatory requirements.
To apply please send your CV by clicking on Apply Button.
Please note: All information on your application and CV is regarded as highly confidential, is not wholly or partially made public or known to third parties. Only authorized employees or external partners of our company have the right to access your information, which is solely used in order for your qualifications to be objectively evaluated for a future career at Pharmassist LTD. Your application and any other information will be kept in our database for at 12 months. In any case, feel free to contact us in order to ask for your CV's earlier deletion or for any other relevant information.