Paramount Recruitment

+44 (0)121 616 3460

+44 (0)121 616 3460

+1 833 455 3043

+1 833 455 3043

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Drug Safety Lead

Drug Safety Lead

I am working with a biopharmaceutical company in Berkshire who is looking for a Drug Safety Lead to join them for a 6-month contract. In this role you will be responsible for the global strategic safety risk management of assigned products and leading the benefit-risk assessment of the product.

Some of your responsibilities will include:
*Developing, presenting and defending appropriate patient safety position on benefit-risk matters
*Lead in a matrix structure for the benefit-risk activities that ensure the timely signal detection, risk management plans and safety analyses in aggregate reports
* Ensure patient safety for the company’s products and maintenance of compliance with the Pharmacovigilance regulations of regulatory agencies
*Timely completion of PV assessment activities through product development
*Strategic lead for safety risk management of assigned projects
*Develops core safety strategy and appropriate safety positions on benefit-risk matters
*Leading the combined, clinical study and post marketing sources, safety signal detection
*Ensure issues and challenges including benefit-risk changes are known by the patient safety organisation
*Ensure compliance with global regulations and ICH guidelines
*Preparation of required regulatory expedited and periodic reports

The company is looking for someone who has experience in:
*Working in the pharmaceutical industry
*Understanding of the global pharmacovigilance and safety requirements from non-clinical development
*Effective team leader and management of a team
*Providing effective and relevant review of complex documents
*Leading safety signal detection, assessment and management
*Leading the benefit risk assessment and working within a matrix team
*Developing core safety strategy on benefit-risk matters

This is an urgent requirement for the company and the deadline for applications is on 12th September. If you are interested in discussing this role further, then please feel free to get in touch with Sabrina Deo on 0121 616 3471 or sdeo@pararecruit.com

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.

Job Reference: Sd-safetylead_1536245332

Broadcast As: 204

Salary To: Negotiable

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Recruitment Consultant: Sabrina Deo

Recruitment Consultant

Sabrina Deo

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