Associate, Pharmacovigilance Operations/Drug Safety

2 weeks, 2 days ago
Full-time
Junior
Operations
Orca Bio

Orca Bio

Orca Bio is revolutionizing allogeneic cell therapy with next-gen therapies for better outcomes and fewer risks, transforming lives through precision and innovation.

Pharmaceuticals
51-250
Founded 2016
$192M raised

Description

  • Serve as the primary contact for adverse event questions and reviews in safety and clinical databases.
  • Review initial and follow-up SAE/AESI reports and issue clinically appropriate queries.
  • Perform quality control and case finalization in the Argus safety database.
  • Oversee case processing vendors and monitor performance KPIs.
  • Investigate safety database issues and submit Help Desk tickets when needed.
  • Assist with regulatory safety reports, literature reviews, safety summaries, and SAE reconciliation.
  • Evaluate reports for completeness, accuracy, and consistency within protocol timelines.
  • Apply FDA and ICH guidance during case review and contribute to MedDRA, WHODrug, and medical-term coding.
  • Maintain relevant safety communications and documents in the eTMF.
  • Generate scheduled and ad hoc safety database reports and provide adverse event subject matter expertise.

Requirements

  • Bachelor’s degree or higher in a clinical or closely related field.
  • 2–3 years of related experience in a biotechnology or pharmaceutical company.
  • 1–2 years of experience in cellular therapy, stem cell transplantation, or oncology preferred.
  • Post-marketing pharmacovigilance experience preferred.
  • Proficiency with the Argus safety database.
  • Working knowledge of MedDRA and WHODrug coding preferred.
  • Experience with Veeva Vault preferred.
  • Excellent written and verbal communication skills.
  • Strong attention to detail, organization, and prioritization skills.
  • Ability to work independently, collaborate cross-functionally, and manage operational and special projects.

Benefits

  • Pre-IPO equity and annual bonus eligibility.
  • Competitive medical, dental, and vision benefits.
  • Paid time off and parental leave.
  • 401(k) plan.
  • Life and accidental death and disability coverage.
  • Subsidized daily lunches and snacks at on-site locations.
  • Remote-based work options with salary adjusted for local market.

Interested in this position?

Apply directly on the company website

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