Description
Real Staffing currently have an exciting contract opportunity for a Product Safety Officer to join our Client in Leamington Spa, UK.The Product Safety Officer will be required to support expedited reporting and PSUR writing activities, ensuring compliance with global and departmental SOP's, and local and European Pharmacovigilance regulations.
Product Safety officer Contract Details;
Start Date: 14th July
Duration: 6 month initial contract
Location: Leamingtom Spa
Rate: Market Rates
Interview times: ASAP
Responsibilities of the Product Safety officer role;
ICSR Expedited Reporting
- To prepare and submit expedited reports on time within the EMEA
Periodic Report Writing
- To prepare PSURs in accordance with departmental SOPs and regulatory requirements, ensuring quality and compliance standards for on time submission are met.
Product Labelling
- To support the review of the safety sections of local labels against the Core Safety Information as required
Regulatory Support
- To be involved in the preparation of responses to questions posed by Regulatory Authorities.
Regulations/Inspections
- Assist in the preparation for EEA Pharmacovigilance audits and inspections, and ensure adequate response and follow-up is given to audit and inspection findings.
Product Safety officer Requirements;
- 1 + years Product Saftety experience with in Pharma / CRO
- post-marketing skills with regards case handling, expedited reporting and PSUR writing
- Ideally with some experience of writing Risk Management Plans.
- Strong working knowledge of European and other relevant international regulations and ICH guidelines.
- Bachelor degree in a life science or healthcare related field.
To find out more about this excellent consulting opportunity, please apply via the link or call Hubert Colvin on