Associate, Pharmacovigilance Operations/Drug Safety

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
• Performs quality control checks and finalization step for each case entered in the Argus database
• Serves as the point of contact for any issues noted in the safety database and generates Help Desk tickets when appropriate
• Aids in the day-to-day oversight of the case processing vendor including the monitoring of KPIs for vendor assessment
• Aids in the preparation of safety reports to be submitted to regulatory agencies
• Aids in the literature review, as required
• Evaluates existing data points and generates 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
• Generates scheduled reports from the safety database to share with clinical team as well as fulfilling any ad hoc requests
• Provides subject matter expertise on adverse events
• Attends and contributes to internal meetings as appropriate for role
• Affords assistance with various projects as assigned by direct supervisor and/or PV department leadership
• Reviews and creates 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 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)

Pay

$90,000 - $115,000 a year

Schedule

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.

Benefits

Other perks include subsidized daily lunches and snacks at our on-site locations.

About the Role

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).

Skills

Proficiency in the Argus safety database system

Working knowledge of MedDRA and WHODrug coding

Veeva Vault experience

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)

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

Veeva Vault experience

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)