[Hiring] Associate, Pharmacovigilance Operations @Orca Bio

Role Description

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 within the safety and clinical databases.
• Initial review of incoming initial and follow up SAE/AESI reports and issues clinically appropriate queries as needed.
• Perform quality control checks and finalization step for each case entered in the Argus database.
• Assists in the day-to-day oversight of the case processing vendor including 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.

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 a biotech or pharmaceutical company.
• 1-2 years of experience in cellular therapy, stem cell transplant, and/or oncology strongly preferred.
• Post-marketing experience desirable.
• Proficiency in the 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 within a growing company.
• Fluent in medical terminology, preferred.

Requirements

• $90,000 - $115,000 a year.
• The anticipated annual salary range 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.

Company Description

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 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.