Colleague capability (see separately available SRL capabilities and responsibilities continuum) will drive Nature and Complexity of Assigned Responsibilities and Activities.
• MD (physician)
• DA-specific knowledge is preferred.
• Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations
• Displays a sound understanding of the scientific basis for therapies and drug-induced diseases. Comprehensive knowledge of drug development process.
• Clinical development and post-marketingexperience to have an understanding of safety context across the drug lifecycle.
• Able to act independently, seeking guidance as appropriate. Demonstrates leadership in day-to- day activities and collaborative skills.
• Can handle more than one complex project simultaneously, prioritizing well and recognizing key issues.
• Ability in, and track record of, working effectively in an advanced matrix structure, including matrix team leadership/representation preferred.
• Recognizes other colleagues’ areas of expertise and utilizes them effectively to achieve team objectives. Runs effective meetings, including all colleagues’ diverse opinions and bringing group to consensus. Next steps and actions are clear.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• Relevant knowledge of Pharmaceutical Company organizational structure, policies, and practices, as applicable to safety Risk Management.
• See also Technical Skill Requirements section.
Some limited travel at times to support the business critical tasks – such as health authority meetings within the US.
MD required. Oncology submission experience preferable.