RD & Sciences - Pharmacovigilance Specialist
The Judge Group Inc.

Location: King of Prussia, PA
Salary: Depends on Experience
Description: Our client is currently seeking a RD & Sciences - Pharmacovigilance Specialist

Length of Contract: 12 months.

This is a hybrid role, must be in office on Tuesdays and Wednesdays.

Hours: Monday - Friday 9:00am-5:00pm

This job will have the following responsibilities:

• Contractor, under the supervision of the US Local Safety Officer (US LSO), is nominated as the US Deputy Safety Officer (US DSO), providing back-up to the US LSO when OOO, and is responsible for the specific tasks (described below) to ensure compliance with relevant Pharmacovigilance (PV) regulations.
• Organized Data Collection System (ODCS):
• Liaises with multiple people within the US Commercial and/or Global Commercial teams who are to inform the Safety Officer about any new ODCS programs.
• Responsible for maintenance and of the global ODCS entries of the programs involving USA via HaloPV to ensure compliance with the PSMF (Pharmacovigilance System Master File) obligations.
• Reviews and comments on questionnaires/surveys/discussion guides for any potential questions that would elicit safety information (i.e. adverse events) which will be used in an ODCS program.
• Provides insights for process improvement and management of HaloPV and handling procedural documents.
  

Qualifications & Requirements:

• Bachelor's degree (e.g. in the biological, nursing, healthcare or pharmaceutical sciences, quality or equivalent
• 3+ years in the pharma industry, and knowledge in pharmacovigilance
• Knowledge of US FDA regulations pertaining to Pharmacovigilance
• Familiarity with international standards and regulatory requirements/regulations related to Pharmacovigilance and Good Clinical Practices
• High level of computer literacy (e.g. Microsoft Office, SharePoint, training systems, document management systems, CAPA System)
• Ability to establish and maintain good working relationships with internal and external stakeholders
• Good verbal and written communication skills in English
• Ability to work independently and as a team player, working in a cross functional environment
• Ability to manage, resolve or escalate issues as appropriate
• Self-motivated, able to prioritize, plan effectively
  

For immediate consideration, please email your resume to Kristen Hawkins

khawkins@judge.com

Thank you

Contact: khawkins@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

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