Position

PV Manager

Job description

Job description

Location

Taipei, Taiwan

Job category

Reg Affairs & Safety Pharmacovigilance

   

Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join  Novo Nordisk. Together we can create life-changing innovation. Together we can make it happen.

 

The position

  • Strategic Oversight:

    Lead the pharmacovigilance department to ensure compliance with both lo-cal and global regulations.

     Develop and implement comprehensive pharmacovigilance policies and pro-cedures aimed at optimizing safety reporting and risk management.

     Foster a high-quality pharmacovigilance reporting environment and ensure the maturation of third-party PV processes.

 

  • Team Management:

     Manage, mentor, and develop the pharmacovigilance team to ensure high performance and continuous improvement.

     Oversee the design and execution of training programs for internal staff and external partners regarding pharmacovigilance practices and regulations.

 

  • Safety Monitoring and Reporting:
     Ensure the timely and accurate reporting of adverse events and safety infor-mation to health authorities and stakeholders.
     Review and analyze safety data to identify trends and escalate safety issues as needed.

 

  • Collaboration and Communication:
      Serve as a key stakeholder and primary point of contact for regulatory agen-cies, internal departments, and external partners.
       Facilitate clear and effective communication, providing guidance and support across departments on safety matters and pharmacovigilance activities.

 

  • Quality Assurance:
        Implement quality assurance initiatives to ensure compliance with standard operating procedures (SOPs), guidelines, and regulatory requirements for both internal stakeholders and external vendors.
        Conduct audits and participate in inspections related to pharmacovigilance activities.

 

Qualifications

  • University degree in Pharmacy, Medicine, Life Sciences, or a related field.
  • In-depth knowledge of pharmacovigilance regulations and quality systems, such as ISO 9001.
  • Advanced degree (Master’s or PhD) in a relevant discipline is preferred.
  • Minimum of 5 years in pharmacovigilance or drug safety within the pharma-ceutical industry.
  • Proven experience in team leadership, project management, and regulatory compliance.
  • Strong background in safety signal detection, risk assessment, and risk man-agement strategies.
  • In-depth knowledge of pharmacovigilance regulations.
  • Excellent analytical and problem-solving skills with attention to detail.
  • Strong leadership qualities and ability to influence at all levels of the organi-zation.
  • Outstanding verbal and written communication skills in English.
  • Proven ability to work in a fast-paced and continuously evolving environ-ment

 

Working at Novo Nordisk

 

At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.