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Pharmacovigilance Specialist

King of Prussia, PA 19406

Posted: 11/26/2024 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 615664 Is job remote?: No Country: United States

Job Description

Target PR Range: 71-81/hr
*Depending on experience

Job Description:

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 and with CSL Behring’s Global Safety & Pharmacovigilance (GSPV) policies.
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.
Pharmacovigilance Agreements:
• Supports the implementation of Pharmacovigilance Agreements (PVAs) in close cooperation with the responsible Global PV Agreements & Alliance (GPAA) and relevant local functions (such as US Commercial).
• Reviews and provides input/comments to the PVAs in close cooperation with the GPAA.
• Negotiates the terms of the PVA with the 3rd Party Service Providers. If needed, brings Legal into the PVA negotiations with the Service Providers.
• Notifies GPAA with confirmation & reason to terminate a PVA.
Training of 3rd Party Service Providers:
• Defines third-party PV training requirements in his/her territory and ensure that this training is completed by the third parties in a timely manner.
Inspection/Audit Readiness:
• Assists the US LSO in maintaining the Inspection Contact List and the Roles & Responsibility List.
• Manages findings assigned to US LSO/DSO.
• Assists 3rd Party Service Provider(s) with audit responses when requested.

Minimum Required Qualifications:
• 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
• Demonstrates initiative with a proactive approach to work

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About King of Prussia, PA

Discover exciting job opportunities in the vibrant area around King Of Prussia, Pennsylvania! Home to the iconic King of Prussia Mall, the largest shopping mall on the East Coast, this region offers much more than just great shopping. With its close proximity to Philadelphia, the City of Brotherly Love, and convenient access to major highways, King Of Prussia provides a perfect blend of suburban charm and urban convenience. Explore career options in this dynamic region, known for its rich history, diverse dining scene featuring local favorites like Philly cheesesteaks, and cultural attractions such as the Valley Forge National Historical Park. Join a bustling community that boasts top-notch art galleries, performance venues like the Kimmel Center, and sports teams like the Philadelphia Eagles. Take the next step in your career and embrace the endless possibilities that King Of Prussia, Pennsylvania, has to offer!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.