Instagram
youtube
Facebook

Senior Manager For Pharmacovigilance And Gdp Internal Audits

5+ years
Not Disclosed
10 Nov. 11, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Manager of PV & GDP Audits

Location: Bagsværd, Denmark
Department: Internal Audits, Novo Nordisk


Are you passionate about leadership and quality in Pharmacovigilance (PV) and Good Distribution Practice (GDP)?

If you are driven to lead a team and play a pivotal role in ensuring the highest standards of quality and compliance in the pharmaceutical industry, this is the opportunity for you. At Novo Nordisk, we are looking for a Senior Manager of PV & GDP Audits to join our Internal Audits team and make a meaningful impact on the quality and safety of our products.


The Position

As the Senior Manager of PV & GDP Audits, you will lead a dedicated team of auditors responsible for identifying quality risks, conducting PV and GDP audits, and escalating potential issues to senior management. You will oversee the audit process, ensuring compliance with key performance indicators (KPIs), budgets, and efficiency standards.

Your key responsibilities will include:

  • Leading and Managing Auditors: Overseeing the PV and GDP lead auditor team, ensuring they are qualified, well-trained, and equipped to handle the complexities of PV and GDP audits.
  • Risk Identification and Escalation: Spotting quality risks, providing recommendations to mitigate those risks, and effectively communicating these to senior leadership.
  • Strategic Contribution: Co-creating and contributing to the strategic agenda for PV and GDP audits within Novo Nordisk, aligning with broader organizational goals.
  • Compliance and Efficiency: Ensuring that internal audit processes are efficient and that the team meets set KPIs and compliance requirements.

This role offers the chance to lead and shape the direction of audit practices while ensuring Novo Nordisk maintains its strong commitment to safety, compliance, and quality.


Qualifications

To thrive in this role, you will need:

  • A Master’s degree in Life Sciences, Pharmacy, or a related field.
  • Extensive experience in the pharmaceutical industry, with a deep understanding of Pharmacovigilance (PV) and/or Good Distribution Practice (GDP) principles.
  • Proven leadership experience with a track record of successfully managing teams and driving process improvements.
  • Strong communication and stakeholder management skills, with the ability to communicate effectively at all levels of the organization.
  • Proficiency in English (both written and spoken).

Experience in auditing will be considered a significant advantage. A genuine interest in quality assurance, compliance, and continuous improvement is essential for success in this role.


About the Department

The Internal Audits department plays a critical role in safeguarding Novo Nordisk’s license to operate by identifying quality risks and actively supporting the organization to mitigate them in a timely manner. We specialize in ensuring compliance with ISO/GMP, PV, and GDP standards, providing strategic insights and recommendations to senior management. Our team has a global presence, with our main office in Bagsværd, Denmark, and a footprint across various global locations.


Working at Novo Nordisk

At Novo Nordisk, we recognize that our employees are our greatest asset. We value the unique skills each person brings to the table and encourage a balanced approach to work and life. We are committed to helping our employees grow professionally and personally, ensuring that each individual can contribute to the company’s mission while also thriving in their personal life. Working at Novo Nordisk means being part of a global team of over 60,000 employees, all working toward the same goal: to change lives for the better.


How to Apply

If you are ready to take on a leadership role in ensuring quality and compliance at Novo Nordisk, apply now. Please upload your CV and include a few sentences on why you are applying for the position. Note that cover letters are not required, and to ensure an efficient recruitment process, please do not add a photo to your CV.


Deadline

The application deadline is 20 November 2024. Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible.


Equal Opportunity Employer

At Novo Nordisk, we are committed to creating an inclusive culture that celebrates the diversity of our employees, patients, and communities. We strive to create a workplace where everyone feels valued and supported, and we encourage individuals from all backgrounds and perspectives to apply. We are an equal opportunity employer.


Contact

For more information, please contact:
Mads Christian Nielsen, Director of Internal Audits at +45 3079 6770.