Associate Medical Director, Safety Science

View full description

Requirements:

• Minimum of 3 years’ experience in industry, with at least 2 years’ experience in drug safety (e.g., safety signaling, risk management and mitigation)
• Excellent medical knowledge and safety surveillance experience in nephrology or immunology preferred.
• Thorough understanding of and ability to interpret patient safety and pharmacovigilance data.
• Understanding of drug safety regulatory requirements for investigational products, including ICH, 21 CFR, and EU GVP regulations
• Experienced in safety data analysis, MedDRA coding, and global regulatory guidelines.
• Strong communication and organizational skills, with the ability to work in a fast-paced environment and adapt to changing priorities.
• Ability to collaborate with internal and external stakeholders to manage complex safety issues.
• Strong interpersonal and communication skills
• Ability to interact with all audiences and clearly and concisely present data, strategy and risk assessment.

Responsibilities:

• Accountable for and leads safety surveillance, risk assessments, and safety management for assigned products including timely and thorough safety review as the lead for the Safety Management Team meetings.
• Support decision-making through risk/benefit evaluations and safety data analysis.
• Collaborate with cross-functional teams on clinical trials, safety protocols, and patient safety issues.
• Supports the development of the clinical safety strategy to be included in the Clinical Development Plan, integrated Safety Management Plan and early phase clinical study protocols.
• Working with the Pharmacovigilance Scientist, and relevant cross-functional team members oversees the creation of Risk Management Plans.
• Develop and contribute to safety reports for regulatory submissions and periodic reports.
• Participate in audits, inspections, and maintain compliance with global pharmacovigilance regulations.
• Accountable for providing rapid and effective communication of important safety issues to PV management, with thorough analysis of the issue and proposed mitigation/ management strategies.
• Represents the project team at the enterprise level and for external safety committees and/or Health Authority interactions for issues relating to clinical safety.