Safety Evaluation and Risk Management Principal
3 weeks ago
We are seeking a highly skilled and experienced Scientific Expert in Pharmacovigilance to join our team at GlaxoSmithKline. As a Safety Evaluation and Risk Management Principal, you will play a critical role in ensuring the safety and efficacy of our products.
Key Responsibilities- Scientific/Medical Knowledge and Expertise
- Responsible for signal detection and evaluation activities for assigned products.
- Ensure that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data.
- Assist in the production of Risk Management Plans (RMPs)/Risk Tables for designated products, in consultation with senior personnel.
- Author regulatory periodic reports and associated documentation globally according to the agreed process and timelines.
- Act as a member of a process improvement initiative team within GCSP.
- Complete any post-audit/inspection activities within the required timeline.
- Use a range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues/problems, and makes decisions with consultation of SERM physician.
- Show commitment to the task and effective time management to meet multiple deadlines successfully and with attention to detail and quality. Able to prioritize own workload with minimal guidance.
- Cross-functional Matrix Team Leadership
- Build effective working relationships and responds to the needs of line functions in the matrix in relation to safety issues.
- Support safety governance/SRTs in the clinical development and post-marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labeling.
- Handle mentoring of junior SERM colleagues, can contribute to evaluating the activities of junior colleagues. Can explain knowledge and skills, and work in new situations. Early capability for Safety Lead role.
- Communications (Verbal, Written) and Influencing (Internal PV Governance and External LTs)
- Share ideas with line manager on ways to improve processes for assigned tasks.
- Able and willing to adjust behaviors and priorities based on changing environment.
- Able to deal with ambiguity and resilient, focused, and optimistic under pressure.
- Show effectiveness in both oral and written communication. Able to effectively express ideas and incorporate feedback into deliverables to create a quality output.
- Demonstrate thorough medical/scientific writing skills are important, as the preparation of detailed evaluations and reports is a core feature of the role.
- Support a safety risk position.
- Keep manager/supervisor informed of progress and activities; escalates issues as appropriate.
- Able to present merits of own point of view.
- 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.
- Experience working in large matrix organizations.
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London, Greater London, United Kingdom GlaxoSmithKline Full timeAbout the RoleWe 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...
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London, Greater London, United Kingdom GlaxoSmithKline Full timeAbout the RoleWe 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...
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London, Greater London, United Kingdom GlaxoSmithKline Full timeAbout the RoleWe 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...
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London, Greater London, United Kingdom GlaxoSmithKline Full timeAbout the RoleWe 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...
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