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Associate, Pharmacovigilance Operations/Drug Safety
OrcaBio website
Remote · 🇺🇸 USA
$60k–95k
middle
2 months ago
full-time
quality 8.2/10
closed
- 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
- 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
- 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.