Associate Director, Pharmacovigilance Safety Science

Role Summary

The Associate Director, Pharmacovigilance Safety Science is responsible for supporting safety evaluation and risk management of Soleno products in both clinical development and the post-marketing setting. This role ensures scientifically sound review and interpretation of data and escalation of safety issues identified through the safety review process to senior management and safety governance as appropriate. The role will lead updates to the safety component of global regulatory submissions (aggregate reports) and facilitate safety governance by assisting in the establishment and operation of cross-functional teams to detect and address product safety issues. Additional responsibilities include supporting safety operations through authoring or participating in written standards updates (e.g., SOPs and SDEAs) to ensure policies and regulations are adhered to correctly and consistently.

Responsibilities

• Contribute clinical safety content to clinical study-related documents, reflecting responsibilities and requirements involved in the collection, evaluation and reporting of safety data from clinical studies, including aggregate reports.
• Participate in periodic safety data review meetings, support the medical director in preparation of material, and coordinate the meetings.
• Prepare and review aggregate safety reports (PADERs, PBRERs, DSURs, etc.).
• Proactively contribute to process improvement activities.
• Maintain a central repository of drug safety documents, including records of signal detection and other PV activities pertinent to regulatory inspections.
• Support oversight of CRO medical monitoring and safety activities to ensure appropriate and timely handling of safety issues.
• Perform standard surveillance activities for a product’s life cycle through review of safety data from clinical trials, safety databases, and published literature.
• Analyze data to support signal assessment and contribute to ad hoc regulatory safety requests using data from multiple sources.
• Lead or participate in cross-functional process initiatives and/or Process Workstreams to drive adherence to regulations, data standards, quality and efficiency.
• Escalate safety issues and communicate on safety matters (e.g., Global Safety Board, QPPV).

Qualifications

• Advanced experience in the pharmaceutical or biotech industry working in Pharmacovigilance, Drug Safety or a related field.
• Degree qualification: typically a Masters in Health Science with 10+ years of experience or doctorate-level degree in a relevant field (e.g., PhD, PharmD, or MD also to be considered).
• Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
• Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
• Strong ability to analyze and interpret complex safety data from multiple sources.
• Excellent people management skills.