Company: CK Clinical
Closing Date: 21 Dec 16
Salary (£): Competitive
Hendre Moolman is recruiting for a Drug Safety Quality Specialist to join a company in the pharmaceutical industry at their site based in Welwyn on...
Hendre Moolman is recruiting for a Drug Safety Quality Specialist to join a company in the pharmaceutical industry at their site based in Welwyn on a contract basis.
The main purpose of the role will be to:
- Implement the controlled document strategy and the support business partners for all relevant regulatory compliance standards and processes related to clinical development and safety/pharmacovigilance.
- Develop Standards, Policies and SOPs, from identification of needs, to execution of development and deployment of outputs and materials.
- Deliver global procedural document packages for Good Clinical Practice and / Good Pharmacovigilance Practice requirements.
Further responsibilities will include:
- Supporting establishment of GxP Standards; Policies & SOP throughout all of the development related organisational enterprises to ensure a consistent documents landscape for standards and processes related to clinical development and safety/pharmacovigilance which meet internal and external standards versus regulatory and compliance related regulations and interpretations with Senior Quality Specialist support and coaching
- Ensuring collaboration with business partners that Policies and SOPs in the controlled document landscape are up-to-date and regulatory compliant versus current Clinical and safety/pharmacovigilance international regulations
- Ensuring that business partner expectations for SOP strategy, materials and deployment are met.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Bachelor degree in a science-related subject or other related field
- Solid knowledge of GCP, PV and regulatory requirements.
- Demonstrated knowledge of GCP, Pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organisational and planning skills.
Benefits include a competitive rate and an initial 12 month contract
CK Clinical is an Equal Opportunities employer and 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 CL37626 in all correspondence.
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