Pharmacovigilance Operations Specialist: Adverse Events

Orca Bio; United States; A distancia; USD 90.000 - 115.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Pre-IPO equity

Annual bonus

Medical, dental, vision benefits

PTO

401(k)

Life and AD&D insurance

Parental leave

Lunch on site

Descripción de la vacante

Orca Bio is seeking an experienced Safety Specialist to review adverse events and support regulatory reporting for investigational products in a biotech setting.

You will liaise with site staff, CRAs, and vendors, perform case processing in Argus, and contribute to safety reporting and documentation, while collaborating with data management, regulatory affairs, and clinical teams at Orca Bio.

Formación

• Bachelor’s degree or higher in a clinical or closely related field.
• 2–3 years of related experience in biotech or pharma.
• 1–2 years in cellular therapy, stem cell transplant, or oncology preferred.
• Post-marketing experience desirable.
• Proficiency with the Argus safety database.
• Knowledge of MedDRA and WHODrug coding; Veeva Vault experience preferred.
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational skills.
• Ability to work independently and in a team setting.
• Ability to manage day-to-day operations and projects.

Responsabilidades

• Main contact for adverse event questions in safety databases.
• Initial review of SAE/AESI reports and related queries.
• Quality control checks and finalization of cases in Argus.
• Oversee vendor for case processing and monitor KPIs.
• Generate help desk tickets for safety database issues.
• Assist in safety reports for regulatory submissions.
• Literature review as required.
• Generate follow-up queries within timelines.
• Ensure consistency and accuracy of AE evaluations.
• Apply FDA/ICH guidelines in case reviews.
• Code medical terms and medications.
• Maintain eTMF status for safety communications.
• Generate scheduled safety reports for the clinical team.
• Provide subject matter expertise on adverse events.
• Attend internal meetings and assist with PV projects.
• Review and create study safety documents.

Conocimientos

Biotech/pharma experience

Cellular therapy experience

Oncology experience

Post-marketing experience

Argus Safety

MedDRA knowledge

WHODrug knowledge

Veeva Vault

Communication skills

Attention to detail

Organizational skills

Teamwork

Independence

Operations management

Medical terminology

Educación

Bachelor’s degree or higher

Herramientas

Argus Safety

MedDRA

WHODrug

Veeva Vault

Descripción del empleo

Orca Bio is seeking an experienced Safety Specialist to review adverse events and support regulatory reporting for investigational products in a biotech setting.

You will liaise with site staff, CRAs, and vendors, perform case processing in Argus, and contribute to safety reporting and documentation, while collaborating with data management, regulatory affairs, and clinical teams at Orca Bio.