Associate Director, Pharmacovigilance Safety Science at Soleno Therapeutics, Inc.

Redwood City, California, United States -

Full Time

Start Date

Immediate

Expiry Date

14 May, 26

Salary

235000.0

Posted On

13 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Safety Evaluation, Risk Management, Regulatory Submissions, Safety Governance, Cross-functional Teams, SOP Authoring, Data Interpretation, Signal Assessment, Process Improvement, Medical Monitoring, Safety Database Review, Literature Review, Regulatory Inspections, People Management, Clinical Development, Post-marketing Activities

Industry

Pharmaceutical Manufacturing

Description

Summary of Job (brief description) 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 management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. The Associate Director, Pharmacovigilance Safety Science will lead updates to the safety component of global regulatory submissions (aggregate reports). This role will facilitate safety governance by assisting in the establishment and operation of cross-functional teams to detect and address product safety issues. Additional responsibilities include support of safety operations through authoring/participation in written standard updates (e.g. SOPs and SDEAs) to ensure policies and regulations are being adhered to correctly and consistently. Responsibilities Contribute clinical safety content to clinical study-related documents, to ensure they reflect 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 (one or more assigned compounds and products) through review of safety data from clinical trials, safety databases, and published literature. Analyze data to support signal assessment and contributes to ad hoc regulatory safety requests using data from multiple sources. Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency. Accountable for the escalation of issues and communication 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. Relevant 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. Salary Range: $210,000-$235,000 (Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.)

Responsibilities

This role supports the safety evaluation and risk management of products during clinical development and post-marketing phases, ensuring scientifically sound data review and management of safety issues. Key duties include leading updates to safety components of global regulatory submissions and facilitating safety governance through cross-functional teams.