Director, Drug Safety Operations
NeuronatherapeuticsDirector, Drug Safety Operations
Location: Remote
Travel: <10% travel to our headquarters in South San Francisco, CA.
We are seeking a skilled, experienced, detail-oriented, and proactive Director of Drug Safety Operations to lead and optimize the operational aspects of our global safety and pharmacovigilance (PV) function and strengthen our PV infrastructure. Reporting to the Head of Drug Safety, the Director is responsible for overseeing outsourced safety operations and internal safety team activities, ensuring vendor compliance, timely case processing, and adherence to regulatory requirements across clinical and post-marketing programs. The Director will routinely address complex project management challenges, maintain safety reporting compliance, and contribute to inspection readiness and scalable PV processes. Ideal candidates will bring hands-on experience in vendor oversight, PV systems, and operational compliance, with the ability to collaborate cross-functionally in a fast-paced, evolving biotech or pharmaceutical environment.
Key Responsibilities
- Oversight of key functions delegated to the Safety Vendor, including all case workflow steps (triaged, processed, communicated with the Sponsor, and submitted/distributed) in a timely manner, as defined in the Safety Management Plan (SMP).
- Ensure the safety vendor submits SUSARs in a timely manner to Regulatory Authorities (RAs), Ethics Committees, and IRBs, in accordance with global and local regulatory requirements.
- Liaise with the safety vendor and Neurona’s Quality, as required, relating to quality issues or process deviations identified.
- Collaborate with internal or external Safety Medical Reviewers, as applicable, relating to case Medical Review/Sponsor Review feedback and workflow processes.
- Participate in clinical study team meetings for assigned compounds or studies to facilitate effective communication between the clinical team, safety vendor, and other key functions such as data management (e.g., reconciliation) and medical writing/clinical science (e.g., safety-related protocol sections, aggregate reports, and reporting processes).
- Collaborate with safety vendor for timely completion and submission of aggregate report reviews (DSUR, 6MLLs, etc., and PBRERS, PADERS))
- Other vendor oversight activities, as requested, including maintenance of SMP, safety communication distribution lists, Contract / Change Orders for new studies; oversight of compliance metrics; and site start-up safety training.
- Develop templates, trackers, and other tools to aid in oversight and/or standardization of PV processes (as applicable)
- Collaborate with Quality Assurance to assure compliance, alignment, and a state of continual audit readiness.
- Support signal detection processes
Qualifications
- Completed degree in Life Sciences, Pharmacy, Nursing, or a related field required.
- 7+ years of pharmacovigilance and safety operations experience in the biotech/pharmaceutical industry.
- Minimum 3–5 years in a senior manager/associate director-level role, ideally in a CNS-focused company and/or cell therapy.
- Prior experience in safety vendor oversight, audit/inspection readiness, and supporting pre- and post-marketing safety activities.
- Working understanding of global pharmacovigilance (PV) regulations as pertains to clinical development, e.g. FDA, EMA/EU CTR, PMDA, GCP, and ICH guidelines.
- Working knowledge of PV databases (e.g., Argus, ArisGlobal, Veeva Safety); experience with MedDRA coding and clinical database interface for AE CRFs preferred.
- Demonstrated ability to oversee drug safety operational activities related to aggregate safety reports, signal detection, safety surveillance, and literature review processes.
- Familiarity with regulatory submission processes (e.g., NDA/BLA/MAA) and late-stage clinical development is preferred; direct experience supporting these activities is a plus.
- Self-starter with strong decision-making skills who thrives in a fast-paced, dynamic environment while remaining open to collaboration and guidance.
- Strong organizational, project management, and problem-solving abilities.
- Effective communicator with well-developed presentation and interpersonal skills.
- Strong attention to detail and accountability for deliverables.
Alert
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This job description is not intended to be exhaustive and may evolve as business needs change. Duties, responsibilities, and activities may be modified or assigned at any time with or without notice.