Senior Global Safety Associate Hybrid

Job Description

PE Global is currently recruiting for a Senior Global Safety Associate for a leading multi-national Biotech client based in Cambridge.This is an initial 12 month contract with strong possibility of extension. The role is mostly work from home but the candidate will need to be able to travel to the clients Cambridge office as and when needed for meetings.Working within the UK and Ireland Affiliate Safety Department, and reporting to the Global Safety Senior Manager, this role will be responsible for ensuring adherence to the clients regulatory commitment for pharmacovigilance.The role will perform a wide variety of drug safety activities within the local affiliate, based on sound knowledge of local pharmacovigilance legislative requirements and company procedures. The role involves collaboration with other affiliate functionsand also with Global Safety colleagues to meet business needs.Role:

• Maintains own current knowledge of and compliance with local safety regulations.
• Maintains awareness of current prescribing information (e.g.SmPC), safety profiles and new risk information for designated products, to support product safety activities.
• Performs business critical core safety activities per legal deadlines including intake of AE reports, follow up with HCPs for complete data, ICSR & aggregate safety report submission to regulators. Handling safety enquiries received to the departmentalinbox from both internal and external stakeholders. Review metrics to monitor MHRA & HPRA submission compliance.
• Assist with submission of DSUR and PSUR safety reports to Regulators and Ethics Committees where applicable. Perform review of relevant PSUR safety signals for MHRA notification.
• Assist with submission of safety risk communications (e.g. Dear Investigator Letter, Urgent Safety Measures, Risk Minimisation Materials etc) in conjunction with Regulatory Affairs, Clinical and Medical Departments.
• Serves as key contact for defined safety activities within the affiliate.
• Collaborate with other affiliate departments including medical and commercial, to provide safety input into cross-functional initiatives (e.g. Patient Support Programs). Ensure PV compliance in these initiatives while understanding local business needs.
• Participate in global, regional and country safety meetings to share best practise on areas of technical expertise.
• Delivers safety reporting training for local affiliate staff and external service providers.
• May assist with safety review of local study protocols, market research programs and social media projects.
• Assists safety team during audits and inspections of PV operations.
• Assist Global Safety Manager or Senior Global Safety Manager with provision of safety activities to support the local business; assist with issue resolution where necessary.

Requirements:

• Be a natural team player with the personal qualities to relate well to people at all levels. With a customer-oriented approach and confident communication skills, you will work well within a cross functioning team.
• Ability to organise and maintain accurate records with unquestionable attention to detail.
• Highly motivated, quick to learn, flexible and analytical.
• Graduate with life science or healthcare degree and proven relevant industry experience within post market and clinical trial pharmacovigilance.
• Understanding of the importance of pharmacovigilance in ethical pharmaceutical marketing and development.
• Proficient in the use of MS Office products to a competent standardWord, Excel, Powerpoint.
• Experience with Safety Databases, particularly ARGUS, would be desirable.
• Teamwork and Cooperation skills; the intention to work cooperatively with team members and those outside the team.
• Ability to analyse problems/issues and determine the most appropriate course of action based on that analysis within defined policies and procedures.
• Focusing efforts on discovering and meeting the customer or clients needs.
• Ability to identify of a problem, obstacle or opportunity, and taking action.
• Driven by a desire to understand and know more about people, things or issues.
• Builds and maintains warm relationships with networks of people.
• Has the intention to work to high standards and personally striving to improve.

Interested candidates should submit an updated CV.Please click the link below to apply, or alternatively send an up to date CV to***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, weare making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you justwant to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in thisadvert.