Drug Safety Assistant

DESCRIPTION:

- Execution of local activities relevant to the management of safety data.

RESPONSIBILITIES:

- Monitor and manage dedicated mailboxes
- Maintain local documentation as required by legislation (including archiving/tracking/retrieval) - lifting of boxes
- Support the submission and distribution of reports and relevant tracking
- Support distribution and tracking of distribution of Follow-Up letters
- Support inspection preparedness activities policies and practices as per Company SOPs
- Consistently apply Archiving policies as per Company SOP

REQUIREMENTS:

- Basic understanding of Pharmacovigilance
- Demonstrated computer literacy
- At least 2 years' experience in the use and management of relational databases
- Ability to solve routine problems and to surface issues constructively
- Ability to make basic decisions with an understanding of the consequences
- Ability to achieve personal objectives while meeting departmental standards of performance
- Ability to work under supervision in a Matrix organization
- Fluency in spoken and written English
- Must have a 4 year degree
- 1-3 YEARS Drug Safety experience
- International Regulatory/Safety Regulations and Guidelines
- Microsoft Excel, Microsoft Outlook, Microsoft Word
- Regulatory Experience