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Manager, Pharmacovigilance Safety Operations

ICONMA

Role overview

Qualifications

  • Solid foundation in GCP and GVP regulations
  • At least 5+ years’ experience in pharmacovigilance and clinical development; oncology experience is preferred
  • Degree in Pharmacy, Nursing, Biosciences or equivalent healthcare degree with pharmaceutical industry background
  • Experience managing safety service providers

Responsibilities

  • Represent Patient Safety as a Study Management Team member
  • Manage review and revision of safety language in relevant study documents
  • Assist with safety data case processing oversight
  • Prepare and maintain safety management plans

Key facts

Hard skills

Pharmacovigilance gRPC Pre-Clinical Development Process Safety Safety Management Systems Safety Audits Drug Development Oncology Cancer Immunology Social Influences

Other skills

  • Safety Assurance
  • Communication
  • Teamwork
  • Organizational Skills

About the company

ICONMA logo

ICONMA

Management Consulting

We provide Professional Staffing Services & Project-Based Solutions for a broad range of Fortune 500 organizations. ICONMA is a certified Woman-Owned staffing company and was founded in 2000. ICONMA’s corporate headquarters is in Troy, Michigan, and has 15+ locations worldwide. What makes ICONMA stand out in a fiercely competitive industry? *We provide integrated, full lifecycle services across a broad range of business and technical platforms. *No single company can duplicate our full range of staffing and permanent recruiting services nationwide. *Proven track record of attracting and retaining exceedingly skilled professional workers in a highly competitive market. SERVICES OFFERED Staff Augmentation (Contract, Contract to Hire, Direct Hire, Single Source) Data Analysis Project-Based Services & Solutions Hire Train Deploy Service Model Offshore Staff Augmentation Payroll Services AREAS OF EXPERTISE - Information Technology - Engineering - Business Professional - Accounting/Finance - Admin/Clerical/Call Center - Healthcare/Clinical/Scientific - Marketing/Creative mail linkedin@iconma.com Phone (888) 451-2519 Website http://www.iconma.com

Company details

Company typeLarge
IndustryManagement Consulting
Company size1001 - 5000

Links

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Job description

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
 
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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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