Senior Drug Safety Associate
SUMMARY: Collection, processing and evaluation of the information on Serious Adverse Events (SAEs) that are reported to the Company, including preparation of SAE narratives, assigning the regulatory reporting status, and accurately entering the data into the Drug Safety Database.
Preparation of periodic safety reports to be submitted to regulatory authorities worldwide and provide routine database searching, extraction and reporting services to the department.
Tasks may include but are not limited to:
- Prepare SAE narratives, complete data entry, and perform QC.
- Manage/perform the generation of Development Safety Update Reports (DSUR) and Periodic Line listings and other regulatory reports.
- Ensure all safety data from assigned projects is handled in accordance with WCT global SOPs, and local working practices.
- Act as a support person in the preparation of study-specific Safety Monitoring Plans
- Contribute in the safety signal generation and evaluation process and in the preparation of documents for other ad hoc reports.
Performance and Quality:
- Manage assigned PV awards and projects. Work with Project Team and ensure PV Team delivers on commitments, and sponsor is aware of status.
- Interact with project team members and investigative site personnel in order to obtain valid and full information regarding SAE cases.
- Supervise the activities of the Drug Safety Associates.
- Interact with assigned contact personnel in Sponsor’s Safety and Medical Affairs departments regarding safety related issues and to provide accurate SAE information for reporting purposes (including regulatory reporting).
- Conduct project-specific safety training for the Project Team.
- Participation in inspections and audits as required, including interviews and provision of requested data.
- Contribute to the preparation and/or implementation of corrective/preventative actions impacting the Pharmacovigilance department.
- Be up to date on applicable regulations and guidelines.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Medical /science background with relevant clinical experience
- Three years of drug safety experience
- Ability and willingness to travel 10% or as needed
- Good computer skills (Microsoft Office applications) with familiarity of safety systems
- Knowledge of medical terminology
- Excellent communication skills
- Detail oriented
- Ability to manage workload and meet strict deadlines
- Fluent in written and verbal English
- Bachelor degree in a science-related field, or nursing, or equivalent.