Planet Pharma
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https://www.propharmagroup.com
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Pharmacovigilance Specialist
1020 First Avenue King of Prussia, PA 19406 US
Posted: 12/22/2023
2023-12-22
2024-03-22
Employment Type:
Contract
Job Category: Pharmacovigilance
Job Number: 596132
Is job remote?: No
Country: United States
Job Description
Target PR Range: 74-84/hr
*Depending on experience
Pharmacovigilance Specialist
12-month contract role
Role Purpose:
Supports the GCSP Global Pharmacovigilance Agreements and Alliances team (GPAA) in maintaining the global overview
on all business relationships with Third Parties which require contracting of pharmacovigilance obligations/responsibilities
and in extending the current processes and systems to align efficiently with CSL standards.
Overviews the preparation and maintenance of Pharmacovigilance Agreements (PVAs) between CSL and/or its affiliates,
and partner companies (e.g., licensor or licensee), Distributors, 3rd Party Service Provider and Investigators/ Institutions
according to CSL standards and international pharmacovigilance regulations. This includes close interaction with all CSL
functions business units involved in PVA preparation and review process and tracking of timely completion.
• Responsible for maintenance of the operational aspects of CSL's globally harmonized Pharmacovigilance
Agreements (PVAs) process, covering products authorized, marketed, or supplied by CSL business units according
to CSL standards / processes and international pharmacovigilance legislations.
• Provide ongoing support to the maintenance and improvement of CSL's Contract Management System and PV
Platform/ System allowing timely preparation, tracking, oversight, follow up, signature, and archiving of contracts
of relevant PVA activities for CSL business units. Review alignment to ensure the information available in the global
overview of PV relevant business relationships is in a current status.
• Contribute to the electronic global PVA system and support GCSP functions in its utilization and maintenance.
Assist in maintaining an enhanced global contract database and updates of PV Platform/ System addressing
workflows for preparation and maintenance of contracts (i.e., PVAs) as well as achieving finally signed contracts
and oversight of all types of business relationships where Pharmacovigilance obligations have to be covered by
PVAs.
• Interact closely with local and global functions (e.g.: PVA Contact Persons (i.e.: LSO/ RSO)) to support the
preparation and update of PVAs. Assist to provide guidance to cover specific pharmacovigilance requirements and
obtain clarification of any PVA related issues and in association with the GCSP GPAA team.
• Contribute to the further development of the current global PVA System including quality standards, processes,
communication, management of interfaces and PV Platform/ System in close liaison with the GCSP GPAA team.
Experience:
• Degree level minimum Bachelor of Science or equivalent, Pharmacy or Nursing.
• Pharmaceutical industry experience of at least 5 years in Pharmacovigilance, relevant clinical environment, or
other pharmaceutical sciences. At least 2 years PV Agreement/ SDEA experience required.
• Experience and good knowledge in the Pharmacovigilance (PV) relevant regulatory framework.
• Strong experience in major aspects of PV to evaluate possible safety issues that might arise from contractual
arrangements and to perform risk-based maintenance of PV-contracts.
• Experience in the handling of electronic systems for data management and in communication required in a global
organization.
Skills:
• Excellent written and oral communication, negotiation skills.
• Technical skills with document management systems.
• Ability to give meticulous attention to detail, prioritize tasks and meet required timelines.
• Able to work effectively and collaborate globally across multiple site functions.
• Strong team player, able to show initiative and sound judgment.
*Depending on experience
Pharmacovigilance Specialist
12-month contract role
Role Purpose:
Supports the GCSP Global Pharmacovigilance Agreements and Alliances team (GPAA) in maintaining the global overview
on all business relationships with Third Parties which require contracting of pharmacovigilance obligations/responsibilities
and in extending the current processes and systems to align efficiently with CSL standards.
Overviews the preparation and maintenance of Pharmacovigilance Agreements (PVAs) between CSL and/or its affiliates,
and partner companies (e.g., licensor or licensee), Distributors, 3rd Party Service Provider and Investigators/ Institutions
according to CSL standards and international pharmacovigilance regulations. This includes close interaction with all CSL
functions business units involved in PVA preparation and review process and tracking of timely completion.
• Responsible for maintenance of the operational aspects of CSL's globally harmonized Pharmacovigilance
Agreements (PVAs) process, covering products authorized, marketed, or supplied by CSL business units according
to CSL standards / processes and international pharmacovigilance legislations.
• Provide ongoing support to the maintenance and improvement of CSL's Contract Management System and PV
Platform/ System allowing timely preparation, tracking, oversight, follow up, signature, and archiving of contracts
of relevant PVA activities for CSL business units. Review alignment to ensure the information available in the global
overview of PV relevant business relationships is in a current status.
• Contribute to the electronic global PVA system and support GCSP functions in its utilization and maintenance.
Assist in maintaining an enhanced global contract database and updates of PV Platform/ System addressing
workflows for preparation and maintenance of contracts (i.e., PVAs) as well as achieving finally signed contracts
and oversight of all types of business relationships where Pharmacovigilance obligations have to be covered by
PVAs.
• Interact closely with local and global functions (e.g.: PVA Contact Persons (i.e.: LSO/ RSO)) to support the
preparation and update of PVAs. Assist to provide guidance to cover specific pharmacovigilance requirements and
obtain clarification of any PVA related issues and in association with the GCSP GPAA team.
• Contribute to the further development of the current global PVA System including quality standards, processes,
communication, management of interfaces and PV Platform/ System in close liaison with the GCSP GPAA team.
Experience:
• Degree level minimum Bachelor of Science or equivalent, Pharmacy or Nursing.
• Pharmaceutical industry experience of at least 5 years in Pharmacovigilance, relevant clinical environment, or
other pharmaceutical sciences. At least 2 years PV Agreement/ SDEA experience required.
• Experience and good knowledge in the Pharmacovigilance (PV) relevant regulatory framework.
• Strong experience in major aspects of PV to evaluate possible safety issues that might arise from contractual
arrangements and to perform risk-based maintenance of PV-contracts.
• Experience in the handling of electronic systems for data management and in communication required in a global
organization.
Skills:
• Excellent written and oral communication, negotiation skills.
• Technical skills with document management systems.
• Ability to give meticulous attention to detail, prioritize tasks and meet required timelines.
• Able to work effectively and collaborate globally across multiple site functions.
• Strong team player, able to show initiative and sound judgment.
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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.
