Global Safety Senior Associate / Cambridge
We are sourcing a Global Safety Senior Associate on behalf of our Multinational Biotechnology Client on an initial 12-month contract located in Cambridge.
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 regulatory commitment for pharmacovigilance.
The incumbent 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 functions and also with Global Safety colleagues to meet business needs.
- Legislation: Maintains own current knowledge of and compliance with local safety regulations.
- Product Knowledge: Maintains awareness of current prescribing information (e.g., SmPC), safety profiles and new risk information for designated products, to support product safety activities.
- Case Management: 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 departmental inbox from both internal and external stakeholders. Review metrics to monitor MHRA & HPRA submission compliance.
- Periodic Reporting: 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.
- Risk Management: 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.
- Cross-Functional Work: 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.
- Key Contact: Serves as key contact for defined safety activities within the affiliate.
- Meetings: Participate in global, regional, and country safety meetings to share best practise on areas of technical expertise.
- Training: Delivers safety reporting training for local affiliate staff and external service providers.
- PV Review: May assist with safety review of local study protocols, market research programs and social media projects.
- Audit: Assists safety team during audits and inspections of PV operations.
- Support: 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.
Qualifications & Experience
- Graduate with life science or healthcare degree and 2-3 years relevant industry experience within post market and clinical trial pharmacovigilance.
- Understanding of the importance of pharmacovigilance in ethical pharmaceutical marketing and development.
- Use of MS Office products to a competent standard - Word, Excel, PowerPoint.
- Experience with Safety Databases, particularly ARGUS, would be desirable.
- Experience with expedited submissions.
- Teamwork and Cooperation; the intention to work cooperatively with team members and those outside the team.
- Analytical Thinking: Ability to analyse problems/issues and determine the most appropriate course of action based on that analysis within defined policies and procedures.
- Customer Service Orientation: focusing efforts on discovering and meeting the customer or client's needs.
- Initiative; the identification of a problem, obstacle, or opportunity, and taking action.
- Information Seeking; driven by a desire to understand and know more about people, things, or issues.
- Relationship Building; builds and maintains warm relationships with networks of people.
- Drive for Excellence; the intention to work to high standards and personally striving to improve.