PV Governance Management

6 days ago

Singapore beBeeCompliance Full time $90,000 - $120,000

Job Title: PV Governance Manager

Job Description:

We are seeking a highly skilled PV Governance Manager to oversee Pharmacovigilance compliance within the clinical development and medical affairs organization.

This role involves ensuring adherence to global regulatory requirements, standard operating procedures (SOPs), work instructions, training, audits, inspections, and CAPA management. The successful candidate will collaborate with internal and external stakeholders to ensure high-quality and compliance standards across all processes.

  • Key Responsibilities include monitoring, reporting, and managing metrics and key performance indicators (KPIs) related to global pharmacovigilance compliance.
  • Ensure quality and compliance activities align with policies, guidelines, regulatory requirements, and standards globally and regionally.
  • Uphold high-quality and compliance standards across all processes with a focus on continuous improvement.
Required Skills and Qualifications:

The ideal candidate should have excellent leadership skills, strong communication skills, and experience in Pharmacovigilance governance. A degree in a relevant field is required.

Desirable qualifications include knowledge of global regulatory requirements, standard operating procedures (SOPs), and work instructions.

Benefits:

This role offers an opportunity to work with a dynamic team and contribute to the success of our organization.

As a PV Governance Manager, you will be responsible for driving quality improvement initiatives and ensuring alignment with global regulatory requirements.

Others:

You will also participate in quality review meetings and analyze performance trends for ongoing improvement.

It's essential to stay updated on PV regulations for specific countries and regions.

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