Clinical Study Manager
6 days ago
Job Summary:
As a key member of the GlaxoSmithKline team, you will play a critical role in ensuring the safety and efficacy of our global assets. This position requires a medical professional with expertise in safety evaluation and risk management to provide scientific guidance and support to our pharmacovigilance and benefit-risk management teams.
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, advising on content from a medical perspective.
- Contribute to global regulatory submissions, including Risk Management Plans (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.
- Make recommendations for the further characterization, management, and communication of safety risks.
- Collaborate with cross-functional teams to ensure the safe and effective use of our products.
Requirements:
- Medical Doctor (physician) degree.
- Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing clinical development and/or post-marketing activities.
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