Manager, PV I

About The Position

1. Oversee drug safety surveillance programmes
- Monitor and manage the companys drug safety surveillance activities including clinical trials and post-marketing programmes.
- Ensure effective oversight of safety processes to maintain product integrity and patient safety.

2. Conduct safety signal detection and risk management assessments
- Identify trends and signals related to product safety and assess potential risks.
- Develop strategies to mitigate risks and ensure the safety of products throughout their lifecycle.

3. Ensure compliance with governmental regulations
- Maintain adherence to regulatory requirements and standards for drug safety.
- Participate in audits and inspections to ensure compliance with legal and regulatory frameworks.

4. Provide safety support to clinical development teams
- Collaborate with clinical teams to address safety concerns during product development.
- Offer expert guidance on safety-related matters to optimise clinical trial outcomes.

5. Manage adverse reaction reports and follow-up
- Review and assess adverse reaction reports for relatedness to products.
- Conduct necessary follow-ups to ensure thorough investigation and resolution.

6. Develop safety surveillance strategies for product lifecycle
- Design and implement safety surveillance plans tailored to each products lifecycle.
- Ensure strategies align with company objectives and regulatory expectations.

The Requriments

-Bachelors degree in Pharmacy Medicine Life Sciences or a related field. Advanced degree (e.g. Masters or PhD) preferred.

- Minimum 5 years of experience in pharmacovigilance drug safety or related fields.
- Experience in clinical trial safety oversight and post-marketing programmes.
- Familiarity with governmental regulations and risk management strategie

Personal skills

1. **Analytical Thinking**
- Demonstrates the ability to critically analyse complex adverse reaction reports and clinical trial data to identify trends safety signals and risk factors. Essential for ensuring robust drug safety surveillance and compliance with regulatory requirements.
2. **Attention to Detail**
- Exhibits meticulous attention to detail when assessing adverse reaction reports ensuring accurate documentation and evaluation of relatedness to products. This skill is vital for maintaining the integrity of safety data.
3. **Regulatory Knowledge**
- Possesses a deep understanding of governmental regulations and guidelines related to pharmacovigilance enabling effective compliance and resolution of legal liabilities.
4. **Risk Assessment Expertise**
- Skilled in conducting risk management assessments throughout the product lifecycle ensuring proactive identification and mitigation of potential safety concerns.
5. **Strategic Thinking**
- Capable of developing and designing comprehensive safety surveillance strategies for products aligning with long-term organisational goals and regulatory standards.
6. **Communication Skills**
- Proficient in conveying complex safety data and insights to clinical development teams stakeholders and regulatory bodies in a clear and concise manner.
7. **Leadership and Team Management**
- Demonstrates the ability to lead and mentor a team of professionals fostering collaboration and ensuring the delivery of high-quality safety surveillance outcomes.
8. **Problem-Solving Abilities**
- Adept at resolving complex safety-related issues including legal liabilities through innovative and evidence-based approaches.
9. **Collaboration and Stakeholder Engagement
- Skilled in working cross-functionally with clinical development teams regulatory authorities and other stakeholders to ensure seamless integration of safety strategies.
Interpretation and Signal Detection
- Expertise in interpreting large datasets to detect safety signals and trends contributing to informed decision-making and proactive risk management.

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

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.