Senior Pharmacovigilance Scientist

My client is currently looking for candidates who have the following attributes:

-Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of the safety aspects of the global Risk Management Plans, in partnership with the Global Safety Physician (GSP) and senior clinical team physician.
- Reviews and provides technical insight to investigator brochures, protocols, informed consents, final study reports and external data monitoring committee charters.
- May present safety information at clinical investigator and commercial meetings.
- Runs routine signal detection process in partnership with GSP, for all products in area or responsibility.
- Authors/provides scientific input and/or review for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines. Co-ordinates and leads the compilation of large PSURs or PBRER requiring a PS team approach and provides high-level summaries on major issues.
- Authors/provides scientific input to the patient safety contributions for global regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and liaison with other functional experts (eg Clinical, Pre-Clinical, Regulatory).

Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice . By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.