Responsibilities:
1. Developing and implementing the overall drug safety strategy for the product, aligning it with business objectives and regulatory requirements.
2. Establishing and maintaining ongoing monitoring of drug safety, including signal detection, evaluation, and risk assessment.
3. Ensuring adherence to global pharmacovigilance regulations, guidelines, and reporting requirements.
4. Developing and implementing risk management plans, including strategies for mitigating potential safety risks.
5. Collaborating with other departments (e.g., clinical development, regulatory affairs, medical affairs) on safety-related matters.
6. Preparing and presenting safety-related information to internal stakeholders (e.g., senior management, safety committees) and external stakeholders (e.g., regulatory authorities, data safety monitoring boards).
7. Performing critical medical review of aggregate reports, providing medical input in safety matters impacting labelling and any safety request received from competent health authorities.
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