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PV Training Specialist ( LC 1655)

TechData Service Company LLC
Bothell, WA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

This is a role designed to assist the Safety Compliance team in the Global Safety Risk Management (GSRM) department at Company and coordinate all activities pertaining to the development of training materials, including the support of training delivery to GSRM and cross-functional departments, and monitoring of training compliance to ensure compliance with global regulatory requirements.

Principal Responsibilities
• Develop and manage onboarding training for new GSRM hires
• Develop and maintain the annual GSRM training program
• Maintain the GSRM personnel and GSRM vendor training curricula
• Maintain the Post Market Adverse Event (PMAE) reporting company and vendor trainings
• Work with cross-functional departments to ensure PMAE reporting training is provided to third party vendors as required by contractual agreements
• Maintain third party vendor training documentation
• Present PMAE training or other general GSRM training to departments within Seagen, as required
• Contribute to the Pharmacovigilance System Master File sections related to training
• Monitor training compliance within GSRM and with company PMAE reporting training
• Manage all GSRM training communication and provide guidance and support for training related questions
• Contribute to GSRM training related SOPs/WIs
• Plan, organize, and implement a range of training activities
• Perform other duties related to the position as required
• Provide support to Safety Compliance staff for processes, systems, and other projects as needed

Qualifications
• 3+ years of experience working in Pharmacovigilance preferred
• Experience in training management role preferred
• Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance and experience with world-wide safety reporting regulations and guidelines preferred.
• Demonstrated experience working with cross functional areas
• Excellent written and verbal communication skills
• Strong computer skills in Windows environment and MS Office Tools proficiency
• Strong organizational skills, attention to detail and ability to identify and analyze problems
• Adept team player with strong work ethics

Education
• Bachelors Degree (Life Sciences preferred)

Competencies
• Written and verbal communications
• Action oriented
• Dealing with Ambiguity
• Time Management
• Peer Relationships
• Process Management
• Managing and Measuring Work
• Perseverance

TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Company Description
www.techdataservice.com

TechData Service Company LLC

www.techdataservice.com

Address

Bothell, WA
USA

Industry

Education

Website

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