Innovations Associate

Description:

Planet Pharma is seeking a highly detail-oriented and motivated PV Systems Solutions & Innovations Associate to support its US Patient Safety Clinical and Vendor Oversight teams. This role provides operational and compliance support to ensure effective performance of baseline PV responsibilities through implementation of global processes, adherence to local regulations, case investigation, and study management. Reporting directly to the Senior Manager, PV Systems Solutions of Operations & Innovations, the Associate will play a key role in maintaining regulatory compliance, supporting vendor oversight, and driving continuous improvements in pharmacovigilance operations.

Key Responsibilities:

• Perform Individual Case Safety Reports (ICSR) activities, including outbound submission and tracking for literature ICSRs, compliance monitoring, and deviation filings.

• Collaborate with the global ICSR team, monitor case workflows, and ensure compliance with reporting timelines.

• Conduct root cause analyses and implement CAPAs for late cases and compliance deviations.

• Oversee study management activities, including case transmission verification (CTV), document review requests, and risk assessments.

• Support Market Research Patient (MAP) and Patient Support Program (PSP) reconciliation, Source Data QC (SDQC), and ensure continuous data integrity in GoMAP.

• Provide oversight for outsourced PV activities, ensuring vendors comply with established frameworks, policies, and procedures.

• Review and manage activity classification requests and promotional materials for compliance.

• Participate in audits, inspections, and training, acting as a subject matter expert for PV-related activities.

• Lead or assist in special projects, process improvement initiatives, and project management tasks, including schedule development and cross-functional collaboration.

Competencies & Skills Required:

• Strong knowledge of the pharmacovigilance environment and regulatory compliance.

• Excellent organizational, problem-solving, and analytical skills.

• Ability to work independently and collaboratively in a fast-paced environment.

• Strong leadership, ownership, and accountability mindset.

• Skilled in project management, data analysis, and compliance monitoring.

• Excellent communication and interpersonal skills to effectively collaborate across multifunctional teams.

Education & Experience Requirements:

• Bachelor’s degree (Life Sciences or related field preferred).

• 5–10 years of pharmacovigilance experience required.

• Proficiency with Microsoft Office Suite, Google Applications, and project management tools.

• Demonstrated ability to translate complex data into actionable insights and compliance strategies.

• Willingness to travel as required.

Salary & Benefits:
The role offers a pay range of $25 – $35 per hour, depending on qualifications and experience. Planet Pharma is an equal opportunity employer that values diversity and is committed to creating an inclusive workplace.