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Senior Pharmacovigilance Operations Manager

South San Francisco, California, 94080

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Job Summary

The Senior Pharmacovigilance Operations Manager is responsible for overseeing and managing operations within the drug safety department. This role involves hands-on involvement in ensuring compliance and safeguarding patient health through effective monitoring and reporting of adverse events.

Responsibilities

  • Lead and manage pharmacovigilance operations to ensure effective risk management and safety monitoring.
  • Collaborate with cross-functional teams to streamline processes and enhance operational efficiency.
  • Oversee the preparation of safety reports and ensure timely submission to regulatory authorities.
  • Develop and implement policies and procedures to comply with industry standards and regulatory requirements.
  • Train and mentor junior staff, fostering a culture of excellence in pharmacovigilance practices.

Qualifications

  • Advanced degree in life sciences, pharmacy, nursing, medicine, or a related healthcare/scientific field.
  • Extensive experience in pharmacovigilance or drug safety operations management.
  • Strong understanding of regulatory requirements and industry standards related to drug safety.
  • Excellent leadership, communication, and interpersonal skills.
  • Proven ability to manage multiple projects effectively under pressure.
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