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Manager/ Senior Manager, Safety Operations

Job ID: BH505224

Category: Pharmacovigilance

Industry: Pharmaceutical


Manager/ Senior Manager, Safety Operations

Position Summary

The Manager/Senior Manager, Safety Operations will support pharmacovigilance (PV), quality control, and vendor oversight activities with respect to the individual case safety report (ICSR) management process.

Key Duties and Responsibilities

  • Support ICSR case processing or oversight of vendor activities within the safety database and other systems according to company policies and procedures.
  • Develop, implement, and follow internal procedures to ensure compliance and quality of the ICSR process including, but not limited to adverse event reporting, case processing, and regulatory submissions within the safety & pharmacovigilance ecosystem.
  • Participate in the development and implementation of process and procedures to ensure ICSR case processing complies with major health authority guidance and regulations (FDA, EMA, and PMDA).
  • Support vendor oversight activities such as monitoring performance metrics, and KPIs per departmental procedures and practices.
  • Manage department training requirements.
  • Support internal audits and inspections to ensure accurate information is provided as needed.
  • Lead and/or address quality control activities such as deviation identification, documentation, and Corrective Action Preventative Actions (CAPA) management related to the ICSR process.
  • Responsible for interdepartmental collaboration, such as, but not limited to Quality and Regulatory to ensure alignment on procedures, shared deliverables, and goals.  
  • Collaborate with other functions to create aggregated reports and safety documents to support risk management such as drug safety reports, due diligence, approval filing activities, SOPs, and policies.
  • Represent Global Safety Operations on clinical study teams.
  • Participate in investigator meetings and safety training internally and externally such as IIT, PSP, and registries.
  • Other duties as assigned

Desired Education, Skills and Experience

  • Bachelor’s degree or higher in a science related field or Health Care Professional (RN, PA, PharmD) preferred.
  • Minimum of 6  years of experience in safety & pharmacovigilance.  Clinical experience preferred.
  • Strong organizational skills, detail oriented and adapts in a dynamic, fast paced global environment.
  • Working knowledge and experience of ICSR processing..
  • Must have the ability to work effectively in an international multicultural matrix organization.
  • Regulatory knowledge is preferable (ICH Guidelines, FDA safety regulations, EMA regulations, and other applicable regulatory guidance documents).

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Type: Direct

Location: San Diego, CA

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