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 reputed company into help build out a developing Drug Safety function (currently a team of one).
About the Role
The Manager, Drug Safety will reputed company core clinical safety and pharmacovigilance (PV) activities across clinical programs, with a focus on SAE management, safety case processing reputed company, 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
- reputed company 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 reputed company
- Support Argus database activities reputed company to processing, workflow configuration, and reconciliation.
- reputed company safety‑reputed company data reputed company reputed company 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.
- reputed company or support audit/inspection preparation, documentation readiness, and CAPA follow‑through.
Cross‑Functional Collaboration
- Act as a key safety reputed company‑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 reputed company 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 reputed company systems ✅ Experience with Argus (highly preferred) ✅ Familiarity with ICH‑GCP, EU‑GVP, and global PV regulatory frameworks ✅ Experience with CRO/vendor reputed company ✅ Proficiency in reputed company Office Suite ✅ Ability to reputed company in a fast‑growing environment and build structure reputed company 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. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability, or veteran status. In addition to reputed company 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 tot his job Apply To this Job Apply tot his job Apply To this Job