Drug Safety Manager
Manager, Drug Safety Onsite - San Diego, CA (5 days/week) Full‑time | Direct Hire We are seeking a Manager, Drug Safety to join a growing clinical‑stage organization advancing multiple early‑ and late‑phase programs. This role is ideal for candidates with strong hands‑on safety operations experience at either a small biotech, large pharma, or CRO company. You will step into help build out a developing Drug Safety function (currently a team of one).
About the Role
The Manager, Drug Safety will oversee core clinical safety and pharmacovigilance (PV) activities across clinical programs, with a focus on SAE management, safety case processing oversight, Argus operations, and CRO/vendor governance. This individual will work cross‑functionally to support compliance, signal detection activities, and inspection readiness across a diverse portfolio, including Phase I- Phase III studies. You will play a key role in developing safety processes, ensuring high‑quality safety data, and serving as a partner to internal teams and external CROs.
Key Responsibilities
Safety Case Management & Operations
- Oversee end‑to‑end SAE and ICSR processes, ensuring compliance with global regulatory timelines.
- Review, triage, and support evaluation of SAEs; ensure accuracy of narratives, MedDRA/WHO‑DDE coding, and case quality.
- Monitor CRO safety case processing, KPIs, quality metrics, and escalate issues as needed.
System & Database Oversight
- Support Argus database activities related to processing, workflow configuration, and reconciliation.
- Oversee safety‑related data within EDC systems (e.g., Medidata Rave), ensuring alignment across clinical and safety databases.
Safety Surveillance
- Support signal detection, trend analysis, and risk evaluation activities across clinical trials.
- Contribute to safety sections of protocols, Safety Management Plans, and risk‑based documents.
Compliance & Inspection Readiness
- Ensure adherence to ICH‑GCP, global GVP, and relevant PV regulations.
- Lead or support audit/inspection preparation, documentation readiness, and CAPA follow‑through.
Cross‑Functional Collaboration
- Act as a key safety point‑of‑contact for Clinical Operations, Regulatory, Quality, Biometrics, and external CRO partners.
- Contribute to aggregate reporting (DSURs, PADERs, PSUR/PBRER support) as needed.
Qualifications ✅ Bachelor's degree required (Life Sciences or related field preferred), Medical background highly preferred (Nursing, PharmD, or MD for example) ✅ 3+ years of Drug Safety / Pharmacovigilance experience (clinical‑stage preferred) in biotech industry or CRO ✅ Strong knowledge of SAE processing, ICSR workflow, MedDRA/WHO‑DDE coding, and EDC systems ✅ Experience with Argus (highly preferred) ✅ Familiarity with ICH‑GCP, EU‑GVP, and global PV regulatory frameworks ✅ Experience with CRO/vendor oversight ✅ Proficiency in Microsoft Office Suite ✅ Ability to thrive in a fast‑growing environment and build structure within a developing department ✅ Must be able to work onsite in San Diego 5 days/week EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change. To find out more about Real, please visit www.realstaffing.com Apply To this Job