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
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