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Scientific Director of Safety Evaluation
2 months ago
Job Summary:
We are seeking a highly skilled and experienced Associate Director to join our team at GSK. As a key member of our pharmacovigilance and benefit-risk management team, you will be responsible for providing scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.
Key Responsibilities:
- Provide scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.
- 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.
- Focus on efficiency and effectiveness to meet the needs of our patients and regulatory authorities.
- 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.
Key Deliverables:
- Production of regulatory periodic reports and associated documentation globally according to the agreed process and timelines.
- Safety contribution to global regulatory submissions, including Risk Management Plans.
- Safety governance/Safety Review Teams 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 labeling.
- 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.
Requirements:
- 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.
Preferred Qualifications:
- Experience working in large matrix organizations.
- Experience working globally in pharmacovigilance or drug development.
- IT competencies.
