Senior Pharmacovigilance Scientist

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Job description

*Senior Pharmacovigilance Scientist - Global BioPharma - 12-month contract - UK REMOTE*

My client is a Global Biopharmaceutical company and they have a position available for a Senior Pharmacovigilance Scientist for an initial 12- month contract. Remote working in the UK.

Within this role the Senior PV Scientist leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and other PV Scientists. He\/she authors and leads PV input to safety documents and regulatory reports. Senior PV Scientist leads meetings and presents safety data and analyses.

Main Responsibilities:

* Leads and\/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
* Leads PS activities of cross-functional project teams for developmental compounds and\/or marketed products.
* Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
* Leads the cross-functional Safety Strategy and Management Team (SSaMT) for large and\/or complex projects.
* Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
* Leads and authors the Reference Safety Information (RSI) for multiple and\/or complex development products and collaborates with GSP and Clinical representatives as needed
* Authors\/provides strategic input or oversight for multiple and\/or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
* Authors\/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA\/BLA, MAA), in partnership with the GSP and other functional experts.
* Trains and mentors' junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.

In order to apply for the Senior Pharmacovigilance Safety Scientist contract, you should possess extensive experience in the field of pharmacovigilance within the Pharmaceutical industry, including experience in writing aggregate safety reports such as PBRERs, PSURs, DSURs, PADERs. Risk Management Plans and experience in signal detection, management and evaluation. You should possess a strong background in clinical trial drug safety and be able to understand, interpret, analyse, and clearly present scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology). Intermediate understanding of epidemiology is preferred.

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. This role can be remote working based 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 .