Planet Pharma
Associate, Global Drug Safety & Pharmacovigilance
Planet Pharma, Plainsboro, New Jersey, United States
Associate, Global Drug Safety & Pharmacovigilance
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Associate, Global Drug Safety & Pharmacovigilance
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Planet Pharma Associate, Global Drug Safety & Pharmacovigilance
Join to apply for the
Associate, Global Drug Safety & Pharmacovigilance
role at
Planet Pharma Job Description
Target Pay Rate: 40-60/hr **salary will be commensurate with experience
Job Description:
Job Description
Target Pay Rate: 40-60/hr **salary will be commensurate with experience
Job Description:
We are seeking an experienced, detail-driven Associate to support the Compliance Team within the Global Drug Safety and Pharmacovigilance (GDS&PV) Department. The ideal candidate will possess a methodical approach to task prioritization, particularly when handling multiple assignments,
must demonstrate strong documentation governance, inspection readiness, and cross-functional collaboration across our global safety network.
Key Responsibilities:
Inspection & Audit Readiness - Actively participate in (un)announced inspections and (partner) audits conducted at the US site. - Ensure real-time support and documentation retrieval during inspections/audits, working closely with global safety teams. - Lead or support logistics and preparation of inspection rooms, document coordination, quality control and documentation tracking, oversight of agenda and deliverables. - Maintain inspection readiness at all times by routinely overseeing critical documentation areas and ensuring compliance with internal and external standards. Documentation Governance - Manage the filing, oversight, and retrieval of safety trial documentation within the Veeva Vault Clinical (eTMF), Quality and RIMS - Conduct quality control reviews and ensure adherence to internal naming conventions, indexing standards, and document metadata requirements. - Oversee proper document numbering and traceability, and maintain real-time overviews of uploaded safety documentation. Systems and Workflow Operations - Upload and maintain safety and compliance documents in Veeva Vault modules. - Monitor, triage, and assign items from shared mailboxes, ensuring smooth team operations. - Administer and maintain SharePoint sites and shared resources for the GDS&PV Compliance Team. - Guide record retention practices and ensure alignment with client and regulatory standards. Cross-Team Support & Collaboration - Serve as back-up support for Compliance Associates and assist in core departmental functions such as: - Training Assignments and compliance in Veeva Vault - GCP/GxP procedure distribution (internal and external) - Coordination and support of compliance meetings (agenda, slides, follow-up) - Safety vendor onboarding and access provisioning in Vault - Liaise with Safety Scientists, QA, Clinical, and Regulatory Affairs to ensure cohesive documentation and process alignment. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Research, Analyst, and Information Technology Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Get notified about new Drug Safety Associate jobs in
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Join to apply for the
Associate, Global Drug Safety & Pharmacovigilance
role at
Planet Pharma Associate, Global Drug Safety & Pharmacovigilance
Join to apply for the
Associate, Global Drug Safety & Pharmacovigilance
role at
Planet Pharma Job Description
Target Pay Rate: 40-60/hr **salary will be commensurate with experience
Job Description:
Job Description
Target Pay Rate: 40-60/hr **salary will be commensurate with experience
Job Description:
We are seeking an experienced, detail-driven Associate to support the Compliance Team within the Global Drug Safety and Pharmacovigilance (GDS&PV) Department. The ideal candidate will possess a methodical approach to task prioritization, particularly when handling multiple assignments,
must demonstrate strong documentation governance, inspection readiness, and cross-functional collaboration across our global safety network.
Key Responsibilities:
Inspection & Audit Readiness - Actively participate in (un)announced inspections and (partner) audits conducted at the US site. - Ensure real-time support and documentation retrieval during inspections/audits, working closely with global safety teams. - Lead or support logistics and preparation of inspection rooms, document coordination, quality control and documentation tracking, oversight of agenda and deliverables. - Maintain inspection readiness at all times by routinely overseeing critical documentation areas and ensuring compliance with internal and external standards. Documentation Governance - Manage the filing, oversight, and retrieval of safety trial documentation within the Veeva Vault Clinical (eTMF), Quality and RIMS - Conduct quality control reviews and ensure adherence to internal naming conventions, indexing standards, and document metadata requirements. - Oversee proper document numbering and traceability, and maintain real-time overviews of uploaded safety documentation. Systems and Workflow Operations - Upload and maintain safety and compliance documents in Veeva Vault modules. - Monitor, triage, and assign items from shared mailboxes, ensuring smooth team operations. - Administer and maintain SharePoint sites and shared resources for the GDS&PV Compliance Team. - Guide record retention practices and ensure alignment with client and regulatory standards. Cross-Team Support & Collaboration - Serve as back-up support for Compliance Associates and assist in core departmental functions such as: - Training Assignments and compliance in Veeva Vault - GCP/GxP procedure distribution (internal and external) - Coordination and support of compliance meetings (agenda, slides, follow-up) - Safety vendor onboarding and access provisioning in Vault - Liaise with Safety Scientists, QA, Clinical, and Regulatory Affairs to ensure cohesive documentation and process alignment. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Research, Analyst, and Information Technology Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Get notified about new Drug Safety Associate jobs in
Plainsboro, NJ . Associate, Global Drug Safety & Pharmacovigilance
Warren, NJ $107,000.00-$117,000.00 2 weeks ago Piscataway, NJ $120,000.00-$168,500.00 2 weeks ago Warren, NJ $107,000.00-$117,000.00 2 weeks ago Manager, Pharmacovigilance Quality Assurance
Bridgewater, NJ $111,000.00-$156,133.00 3 weeks ago Manager, Pharmacovigilance Quality Assurance
Bridgewater, NJ $111,000.00-$156,133.00 2 weeks ago Associate Director, Global Drug Safety & Pharmacovigilance
Princeton, NJ $152,000.00-$228,000.00 1 week ago Princeton, NJ $150,000.00-$250,000.00 2 weeks ago Director, Global Drug Safety & Pharmacovigilance Scientist
Princeton, NJ $188,560.00-$282,840.00 1 week ago Sr. Medical Director - Drug Safety and Pharmacovigilance
Somerset, NJ $285,906.00-$375,253.00 2 weeks ago Executive Director, Head of Pharmacovigilance - Safety Science
Associate Director to Senior Director, Clinical Research - Oncology
New Jersey, United States $230,000.00-$340,000.00 3 weeks ago South Plainfield, NJ $21.88-$27.88 2 weeks ago Collision Repair Shop Supervisor/Instructor
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Truck Driver - Hiker/Vehicle Transporter/CDL - Part Time
Truck Driver - Hiker/Vehicle Transporter/CDL - Part Time
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr