Drug Safety Associate
Mary Tilston at CK Clinical is recruiting for a Drug Safety Associate to join a company in the Pharmaceutical industry at their site based in Central London on contract basis.
The main purpose of the role will be to:
- Be responsible for all operational, quality and administrative aspects of Drug Safety in connection with the collection, safety evaluation, reporting, cross reporting, dissemination and filing of all adverse event reports, ensuring that internal and regulatory timelines are met.
- Review and input into the SAE Processing Guideline/Safety Management Plan and ensure the PV service provider is adhering to the SAE Processing Guideline/Safety Management Plan and that cases are being processed in a timely fashion.
- Acknowledge the receipt of SAE cases, checking completeness, seriousness and expectedness and ensure the collection, safety review and internal reporting/dissemination of all SAE reports.
Further responsibilities will include:
- Assisting in preparing periodic safety updates and ensuring accurate review and reporting.
- Reviewing/auditing CRO SAE reporting or pharmacovigilance procedures as and when appropriate and assisting in reviewing/developing Drug Safety SOPs and ensuring the appropriate training of staff.
- Assisting the team in the coding of AEs and medications using appropriate versions of the available dictionaries.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level or above in life sciences or a related field with demonstrable experience of working within Drug Safety in a CRO, Pharmaceutical or Biotechnology company.
- Must have relevant experience in PV practice, MedDRA coding, and WHO drug dictionary training as well as a good understanding of PV processes and strong experience of case processing and reporting.
- Able to work to deadlines with the ability to interact effectively at all levels including external partners and clients.
- PV auditing experience would be helpful but not essential.
This is an excellent opportunity to join a global speciality pharmaceutical company.
For more information or to apply for this position, please contact Mary Tilston on 01438 768717 or email email@example.com. Alternatively, please click on the link below to apply online.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL34565 in all correspondence.