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Manager, Pharmacovigilance Safety Operations

ICONMA, LLC

Bothell, WA(remote)

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JOB DETAILS
SALARY
$95–$100 Per Hour
SKILLS
Biotech and Pharmaceutical, Clinical Information, Communication Skills, Cross-Functional, Documentation, Drug Development, Follow Through, GCP (Good Clinical Practices), Health Plan, Healthcare, Healthcare Providers, Multitasking, Nursing, Oncology, Organizational Skills, Patient Safety, Performance Metrics, Pharmacovigilance, Pharmacy, Presentation/Verbal Skills, Safety Process, Standard Operating Procedures (SOP), Surveillance, Team Player, Writing Skills
LOCATION
Bothell, WA(remote)
POSTED
8 days ago
Our Client, a Clinical-Stage Cell Therapy company, is looking for a Manager, Pharmacovigilance Safety Operations for their Bothell, WA/ /CA/Remote location.
 
Responsibilities:
  • Represent Patient Safety as a Study Management Team member
  • Interface with the Study Management Team, safety service provider, and medical safety reviewer to maintain safety processes supporting assigned studies
  • Assist with safety data case processing oversight
  • Manage review and revision of safety language in relevant study documents
  • Prepare and maintain safety management plans
  • Contribute to service provider oversight
  • Assess changes to the ICF safety information by sites and IRBs
  • Assist with the preparation and management of aggregate reports such as the Development Safety Update Report
  • Prepare and contribute to written processes supporting pharmacovigilance activities
  • Assist in maintaining pharmacovigilance key performance indicators and metrics, with specific focus on expedited report submissions and subsequent investigator notifications
  • Monitor pharmacovigilance-related service provider compliance
  • Contribute to the safety assessment strategy and aggregate safety review
  • Provide pharmacovigilance-specific guidance for service provider audit planning
  • Assist with authoring pharmacovigilance standard operating procedures
  • Other activities as assigned
 
Requirements:
  • Solid foundation in GCP and GVP regulations
  • Ability to work independently and effectively in a remote-based, multifunctional team
  • Experience working with and managing safety service providers
  • Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical/pharmaceutical information and safety data
  • Experience in the preparation and authoring of aggregate safety reports
  • Thorough understanding of the drug development process and context applicable to safety surveillance activities
  • Ability to execute and follow-through to completion and documentation
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Excellent oral and written communication skills
  • Degree in Pharmacy, Nursing, Biosciences or equivalent healthcare degree with pharmaceutical industry background
  • At least 5+ years’ experience in pharmacovigilance and clinical development; oncology experience is preferred
  • Direct experience in a small biotech environment in addition to large pharmaceutical
  • experience is a significant plus
  • Immuno-oncology therapeutic area experience or equivalent required; CAR-T
  • experience preferred
  • Demonstrated experience managing PV service providers
 
Why Should You Apply?

About the Company

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ICONMA, LLC

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