United States onlyReporting To: Vice President, Global Regulatory Affairs
Department: R&D: Clinical Development
People Manager: No
FLSA Status: Exempt
Location: San Diego (hybrid) or remote
Position Summary
The Senior Manager/Associate Director, Drug Safety Operations will be responsible for oversight of safety operation activities with vendors and partners, including implementing safety reporting processes, monitoring compliance with internal standard operating procedures, overseeing adverse event case management, oversight of the drug safety database, providing support to study teams and projects. Reporting to the Vice President, Global Regulatory Affairs the Senior Manager/Associate Director, Drug Safety Operations will collaborate cross-functionally to support safety activities for clinical trials.
Responsibilities include but may not be limited to:
- Provide guidance and oversight of safety responsibilities outsourced to safety vendors
- Oversees/ensures safety case queries are resolved as per defined processes (interfacing with clinical operations team and clinical vendors, as required)
- Monitors performance and quality compliance (e.g. quality metrics, other reports) of the safety vendor and the quality output of the ICSRs; provides appropriate feedback and training
- Oversee case workflow (case receipt through submission) between safety vendor and Longboard
- Review incoming adverse events to determine the action required
- Manage preparation and processing of SAE/SUSAR reports activities for all investigational drugs
- Ensures safety cases are closed within required timelines with resolution of required queries
- Ensure corporate compliance with domestic and international adverse event reporting requirements for all products in worldwide development programs
- Operational oversight and execution of operational safety tasks for all clinical programs
- Supports safety data reconciliation activities and ensures safety vendor responsibilities are completed within the required timelines
- Oversee maintenance of safety database for tracking, storing, and reporting serious adverse events from all clinical trials.
- As required, present safety reporting processes according to study protocol at Investigator Meetings or to other required audience.
- Collaborate with partners on the exchange of safety data, safety monitoring, and the safety profile of investigational drugs as defined in Pharmacovigilance Agreements; Monitor partner compliance with partner Safety related activities as per agreement
- Responsible for UAT and Implementation of updates within Safety Database
- Oversee periodic MedDRA and WHO Drug upgrades
- Perform and manage SAE reconciliation between safety and clinical databases
- Collaborate with vendors for TMF Safety documents filing and review
- Contribute to preparation of relevant sections of clinical study reports, annual reports (e.g. DSUR), aggregate reports, expedited safety reports and other regulatory documents
- Oversee submission activities for DSUR, ICSRs and aggregate reports
- Author and maintain SOPs as applicable
Minimum Requirements
- Bachelor’s degree in Life Sciences, Healthcare, or relevant field, advanced degree preferred
- 5-8 years of progressive experience working in Drug Safety
- Knowledge of and experience with international regulatory adverse event reporting requirements
- Hands-on experience with adverse event case processing
- Experience with Safety Databases (Argus, ArisG or other)
- Previous clinical healthcare experience (e.g. nursing) a plus
- Excellent interpersonal communication skills and ability to work effectively as part of a team
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $150,000.00-$180,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
- Hybrid work schedule out of our La Jolla office, 2-3 days a week
- Competitive compensation package including bonus opportunities and stock options
- Medical, Dental & Vision Plans
- 401(k) Plan, including company match with immediate vesting
- Flexible Time Off, including one week off in the summer and one week off around December holidays
- 11 paid company holidays per year
- An opportunity to do truly meaningful work to make a lasting impact
- Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
- Flexible spending account for medical care
- Life insurance, short and long term disability plans
