Drug Safety Associate

Are you looking for a new role? Do you have pharmacovigilance experience? Have you got experience working with signal detection and data analysis? Then, I have the role just for you As a Drug Safety Associate you'll be a key member of the drug safety management group, which is responsible for the outsourced activities within the Drug Safety Surveillance group. The SABR Associate will support with drug processes and support senior managers in the process. This is a 12 month contract, based in Maidenhead. Key duties: Responsible for ensuring departmental compliance with regulatory requirements and department/company operating procedures. Manages the delayed case investigation process by assisting SABR Management with delayed case investigations and reviewing the investigations to ensure root cause assignment can be made. Supports SABR Management team and corporate partnerships by developing and generating metrics and strategies to maintain regulatory compliance. Supports internal and external compliance audits as a Pharmacovigilance (PV) Quality Subject Matter Expert (SME), participates in PV and Good Clinical Practice (GCP) audit and regulatory inspection preparation and execution. Tracks Individual Case Safety Report (ICSR) inquiry responses to regulators. Participates in departmental Continuous Quality Improvement (CQI) initiatives. Manages SABR PV documentation archiving according to corporate records management procedures Requirements: Hold a degree in a related field. Have over 3 years experience in the industry - ideally in a pharmaceutical or clinical environment. Have some experience working with GCP audits and regulatory inspection preparations. Strong communication skills A good team player Apply now by calling me on (option 4) Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application. Candidates must be eligible to live and work in the UK. For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.