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Associate Medical Director
2 months ago
As a key member of the GSK team, you will play a crucial role in ensuring the safety and efficacy of our global assets. Your expertise in pharmacovigilance and risk management will be instrumental in identifying and mitigating potential risks associated with our products.
Key Responsibilities:- Provide medical 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.
- Participate in the production of regulatory periodic reports and associated documentation globally according to the agreed process and timelines.
- Advise on content of regulatory period reports from the medical perspective.
- Contribute to global regulatory submissions, including RMPs, providing medical judgment as needed.
- Develop and implement risk-reduction strategies that are medically appropriate and implemented in clinical study protocols and/or product labeling.
- Present complex issues to senior staff members at the GSK Senior Governance Committees.
- Medical Doctor (physician) degree.
- 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.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.
