Senior Pharmacovigilance Scientist

Key Responsibilities

• Overseeing service providers executing Individual Case Safety Report (ICSR) tasks and medical device reports.
• Proactively answering queries and sharing your subject matter expertise with stakeholders, including business partners, auditors, and inspectors.
• Conducting process reviews to design and implement process improvements that enhance quality and compliance.
• Identifying root causes of non-compliance and agreeing on Corrective Actions and Preventative Actions (CAPAs), with responsibility for implementation.
• Assessing the impact of new or updated regulatory requirements on your area of expertise.

Qualifications and Experience

• A foundational educational background, such as an undergraduate degree, or equivalent on-the-job pharmacovigilance experience.
• Demonstrated experience in various areas of pharmacovigilance and an understanding of international regulations (ICH, EU GVP Modules, FDA).
• A good grasp of the pharmaceutical industry and the rapidly evolving personalised healthcare landscape.
• Medical device processing experience is desirable but not mandatory.

Ideal Candidate Attributes

• Profound Knowledge: In-depth understanding of ICSR case processing and broad knowledge of the end-to-end ICSR process.
• Accountable Leadership: A proactive leader who is self-motivated and excels in process development and issue management.
• Quality Mindset: Maintains procedural documents, devises strategies to mitigate risks, and transparently escalates issues.
• Effective Oversight: Skilled at relationship management and capable of analysing metrics to ensure service quality.
• Strong Communicator: Ability to influence colleagues and articulate processes to external stakeholders, particularly during regulatory inspections.
• Critical Thinker: Can connect processes, data, and ideas to see the bigger picture and create impactful solutions.
• Adaptable Team Player: Open and supportive in both co-located and virtual teams, capable of managing ambiguity and reprioritising tasks.

This role is an excellent opportunity for those who are passionate about patient safety and eager to make a meaningful impact within the pharmaceutical sector. If you possess the required skills and experience, this could be the perfect position for you!