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Safety Evaluation and Risk Management Principal
2 months ago
We are seeking a highly skilled and experienced Safety Evaluation and Risk Management Principal to join our team at GlaxoSmithKline. As a key member of our pharmacovigilance and benefit-risk management team, you will be responsible for providing medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.
Key Responsibilities- Scientific/Medical Knowledge PV Expertise: Ensure scientifically sound review and interpretation of data and management of safety issues and escalate safety issues identified through the safety review process to senior management and safety governance as appropriate.
- Cross-functional Matrix Team Leadership: Build effective working relationships and respond to the needs of line functions in the matrix in relation to safety issues.
- Communications (Verbal, Written) and Influencing (Internal PV Governance and External LTs): Share ideas with line manager on ways to improve processes for assigned tasks and demonstrate thorough medical/scientific writing skills.
- Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pham D). Advanced degree preferred.
- Relevant experience in pharmacovigilance or drug development.
- Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
- Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).
We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.
