Pharmacovigilance Operations Specialist

Orca Bio; United States; Remote; USD 90,000 - 115,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, and vision benefits

PTO

401(k) plan

Life insurance

AD&D coverage

Parental leave

Subsidized lunches and snacks

Job summary

Orca Bio seeks a Pharmacovigilance Specialist to review adverse events and assist in regulatory reporting for investigational products. You will serve as a primary safety contact with sites, CRAs, and vendors, and collaborate with data management, clinical operations, regulatory affairs, and quality.

The role requires a bachelor’s degree, 2–3 years in biotech/pharma, experience with Argus, MedDRA/WHODrug preferred, and strong communication.

Qualifications

• A minimum degree of bachelor’s or higher in a clinical or closely related field.
• 2–3 years of related experience in biotech or pharmaceutical company.
• 1–2 years of experience in cellular therapy, stem cell transplant, and/or oncology preferred.
• Post-marketing experience desirable.
• Proficiency in Argus safety database system.
• Working knowledge of MedDRA and WHODrug coding preferred.
• Veeva Vault experience preferred.
• Excellent written and verbal communication skills.
• Strong attention to detail.
• Excellent organizational and prioritization skills.
• Ability to work independently and in a team setting.
• Ability to manage day-to-day operations as well as special projects in a growing company.
• Fluency in medical terminology preferred.

Responsibilities

• Serves as the main point of contact for adverse event questions and reviews in safety databases.
• Initial review of SAE/AESI reports and related queries.
• Perform quality control checks and finalization for each case in Argus.
• Oversee case processing vendor operations and monitor KPIs.
• Act as safety database contact and generate Help Desk tickets.
• Assist in preparing safety reports for regulatory agencies.
• Engage in literature review as required.
• Generate follow-up queries within protocol timelines.
• Ensure completeness and accuracy of AE entries.
• Apply FDA and ICH guidelines in case reviews.
• Contribute to coding of medical terms, procedures, and concomitant medications.
• Maintain status in eTMF for safety communications.
• Generate scheduled and ad hoc safety reports for clinical teams.
• Provide subject matter expertise on adverse events.

Skills

Communication skills

Attention to detail

Organizational skills

Teamwork skills

Project management

Medical terminology

Independent work

Education

Bachelor's degree or higher in clinical field

Tools

Argus safety database

MedDRA

WHODrug coding

Veeva Vault

Job description

Orca Bio seeks a Pharmacovigilance Specialist to review adverse events and assist in regulatory reporting for investigational products. You will serve as a primary safety contact with sites, CRAs, and vendors, and collaborate with data management, clinical operations, regulatory affairs, and quality.

The role requires a bachelor’s degree, 2–3 years in biotech/pharma, experience with Argus, MedDRA/WHODrug preferred, and strong communication.