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

Health Care

51-200 (110)

Founded 2016

$192M raised

7 open positions

Links

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Associate, Pharmacovigilance Operations/Drug Safety

17 hours, 19 minutes ago

Anywhere

Full-time

Junior

Operations Specialist

Operations

Apply Now

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

51-200

Founded 2016

$192M raised

View All Jobs 7

Description

Serve as the primary contact for adverse-event questions, requests, and reviews in safety and clinical databases.
Review initial and follow-up SAE/AESI reports and issue clinically appropriate follow-up queries.
Assess adverse-event reports for completeness, accuracy, and legibility, using FDA and ICH guidance.
Perform quality-control checks and finalize cases in the Argus safety database.
Support preparation of safety reports for submission to regulatory agencies.
Oversee day-to-day activities of the case-processing vendor and monitor vendor KPIs.
Code medical terms, procedures, and concomitant medications consistently and on time.
Maintain safety communications and documents in the eTMF and generate scheduled or ad hoc safety reports.
Collaborate with data management, clinical operations, regulatory affairs, quality, medical affairs, and external stakeholders.
Develop and review study safety documents, including Safety Management Plans, safety summaries, and SAE reconciliations.

Requirements

Bachelor’s degree or higher in a clinical or closely related field.
2–3 years of relevant experience in a biotechnology or pharmaceutical company.
Proficiency with the Argus safety database system.
Strong written and verbal communication, organizational, prioritization, and attention-to-detail skills.
Ability to work independently and collaboratively while managing daily operations and special projects in a growing company.
Experience in cellular therapy, stem cell transplant, and/or oncology preferred.
Post-marketing pharmacovigilance experience preferred.
Working knowledge of MedDRA and WHODrug coding preferred.
Experience with Veeva Vault preferred.
Fluency in medical terminology preferred.

Benefits

Pre-IPO equity and annual bonus eligibility.
Competitive medical, dental, and vision coverage.
Paid time off.
401(k) plan.
Life, accidental death, and disability coverage.
Parental leave benefits.
Subsidized daily lunches and snacks at on-site locations.

Interested in this position?

Apply directly on the company website

Apply Now

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