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.

SKILLS:

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.
- 1-3 years Drug Safety Experience.
- International Regulatory/Safety Regulations and Guidelines.
- MS Excel, MS Outlook, MS Word.
- Regulatory Documentation.