Safety Surveillance Associate III
Safety Risk Leads (SRLs) perform proactive Safety Surveillance (SS) and Risk Management (RM) to effect product safety signal detection & evaluation, risk assessment and safety risk minimization. SRL in SSRM may be assigned as the product “safety-management-team” (e.g. Risk Management Committee) Chairs and Asset (Product) Team safety representatives, flexibly supporting all BU/RUs but Oncology). SRLs may act as a Point of Contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing WWS position(s) on safety.
Years of Experience 5-7.
• 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-marketing experience 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.
Some limited travel at times to support the business critical tasks – such as health authority meetings within the US.