Associate, Pharmacovigilance Operations/Drug Safety

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

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Summary:

• Responsible for reviewing adverse events and assisting in the determination of regulatory reporting for assigned investigational products
• May serve as a liaison to internal and external stakeholders for AE reporting issues (i.e. site staff, CRAs, case processing vendor)
• Works in collaboration with other functional groups such as data management, clinical operations, regulatory affairs, quality, and medical affairs

Key Responsibilities:

• Serves as the main point of contact for any adverse event questions, requests, and/or reviews withinthe safety and clinical databases
• Initial reviewof incoming initialand follow up SAE/AESI reportsand issues clinically appropriate queries as needed
• Performquality control checks andfinalization step for each case entered in theArgus database
• Assists in the day-to-day oversight of the case processing vendorincluding the monitoring of KPIs for vendor assessment
• Serves as the point of contact for any issues noted in the safety database and generates Help Desk tickets when appropriate
• Assists in the preparation of safety reports to be submitted to regulatory agencies
• Assists with literature review, as required
• Evaluation of existing data points and generation of follow-up queries for all reports within protocol specified timelines
• Ensures consistency in the evaluation and assessment of AE reports for completeness, accuracy and legibility for case entry
• Exercises judgement and use of knowledge of FDA and ICH guidelines in performing case reviews
• Contributes to coding of medical terms, procedures, and concomitant medications in a consistent and timely manner
• Maintains contemporaneous status within the eTMF as it relates to relevant safety communications and documents
• Generate scheduled reports from the safety database to share with clinical team as well as fulfilling any ad hoc requests
• Provide subject matter expertise on adverse events
• Attends and contributes to internal meetings as appropriate for role
• Assists in various projects as assigned by direct supervisor and/or PV department leadership
• Review and create study related documents such as Safety Management Plans, safety summaries, and SAE reconciliation

Required Qualifications

• A minimum degree of bachelor's or higher degree in a clinical or closely related field
• 2-3 years of related experience gained in abiotech or pharmaceutical company
• 1-2 years of experience in cellular therapy, stem cell transplant, and/or oncology strongly strongly preferred
• Post-marketing experience desirable
• ProficiencyintheArgus safetydatabasesystem
• Working knowledge of MedDRA and WHODrug coding preferred
• Veeva Vault experience preferred
• Excellent written and verbal communication skills
• Strong attention to detail
• Excellentorganizational and prioritizationskills
• Ability to work independently and in a team setting
• Ability to manage day-to-day operations as well as special projects within a growing company
• Fluent in medical terminology, preferred

$90,000 - $115,000 a year

The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.