Senior Pharmacovigilance Scientist, Risk Management

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Job description

*Senior Pharmacovigilance Specialist, Risk Management -Pharma - 18-month contract - Remote UK*

My client is a Global Biopharmaceutical company and they have a position available for a Senior Pharmacovigilance Specialist, Risk Management to join their team for an initial 18- month contract. Remote working available, but must be based in the UK.

Within this role your responsibilities as the Senior Pharmacovigilance Specialist will be:

* Signal detection and authorship of signal work-up documents in collaboration with Medical Safety Science Medical Evaluation (MSS-ME) team member
* Authorship of Company Core Data Sheet (CCDS) sections and associated supporting documentation
* Authorship of aggregate safety reports (e.g., PSURs)
* Authorship of risk management plans
* Authorship of responses to regulatory agency safety enquiries
* Contributes to safety analyses in Regulatory submissions (e.g., Marketing Authorisation Application (MAAs), New Drug Application (NDAs))
* Reviews global literature for identification of potential safety concerns
* Performs safety review of clinical trial protocols, investigator brochures, study reports, informed consent forms, and other study related documents for assigned studies
* Reviews standard reference documents in collaboration with a MSS-ME team member

In order to apply for the Senior Pharmacovigilance Specialist contract, you should possess a Life science degree and have solid pharmacovigilance experience, especially within aggregate report writing, signal management and Risk Management.

Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.

To apply for this position or if you want to discuss other roles that we are working on, please do not hesitate to contact Roberta Atkins on .