Scientific Director
1 month ago
As a key member of our team, you will provide scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. Your primary responsibility will be to ensure scientifically sound review and interpretation of data and management of safety issues, escalating safety issues identified through the safety review process to senior management and safety governance as appropriate.
You will be part of a team of physicians and scientists supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally. Your focus will be on efficiency and effectiveness to meet the needs of our Patients and Regulatory Authorities.
We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. Our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Key Responsibilities- Production of regulatory periodic reports and associated documentation globally according to the agreed process and timelines; advise on content of regulatory period reports.
- SERM safety contribution to global regulatory submissions, including RMPs.
- Safety governance/SRTs in the clinical development and post marketing settings to detect and address product safety issues.
- Ensuring risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
- Making recommendations for the further characterization, management, and communication of safety risks.
- Presenting complex issues to senior staff members at the GSK Senior Governance Committees.
- Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D). Substantial experience in pharmacovigilance or drug development.
- Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing clinical development and/or post-marketing activities.
- Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
- Ability to function successfully in cross-functional groups.
- Experience working in large matrix organizations.
- Experience working globally in pharmacovigilance or drug development.
- IT competencies.
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