At a Glance
- Tasks: Lead global pharmacovigilance audits and assess compliance with regulations.
- Company: Join Kaztronix, a leader in the pharmaceutical industry with a commitment to quality.
- Benefits: Competitive salary, travel opportunities, and professional growth.
- Other info: Extensive travel (50-75%) for international audits and collaboration.
- Why this job: Make a real impact on global health by ensuring safety and compliance.
- Qualifications: 8+ years in pharmacovigilance or GxP auditing; strong analytical skills required.
The predicted salary is between 45000 - 55000 £ per year.
- Senior Pharmacovigilance (PV) Auditor
- Position Summary
- We are seeking an experienced
Senior Pharmacovigilance (PV) Auditor to lead and execute global pharmacovigilance audits across internal functions and external business partners.
This role requires a strategic auditor with extensive knowledge of global PV regulations, Gx P compliance, and vendor oversight.
The successful candidate will travel internationally to conduct on-site audits, assess compliance with regulatory requirements, and identify opportunities for continuous quality improvement.
Key Responsibilities
- Plan, conduct, and lead global pharmacovigilance audits of vendors, service providers, affiliates, and internal departments.
- Travel extensively to perform domestic and international on-site audits.
- Evaluate compliance with global pharmacovigilance regulations, GVP/GCP requirements, company procedures, and contractual obligations.
- Review audit protocols, quality agreements, SOPs, and applicable regulations to develop effective audit strategies.
- Assess vendor quality systems, pharmacovigilance processes, case processing, signal management, risk management activities, and safety reporting practices.
- Review historical audit reports, CAPAs, inspection findings, and quality metrics to identify trends and areas of risk prior to conducting audits.
- Prepare detailed audit plans, execute interviews, review documentation, and document observations in comprehensive audit reports.
- Evaluate the effectiveness of corrective and preventive actions (CAPAs) and verify implementation.
- Partner with Quality Assurance, Pharmacovigilance, Clinical Operations, Regulatory Affairs, and external vendors to drive compliance improvements.
- Support inspection readiness activities and regulatory inspections when required.
- Maintain audit schedules and contribute to the annual global audit program.
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related scientific discipline; advanced degree preferred.
- 8+ years of Pharmacovigilance, Quality Assurance, or Gx P auditing experience within the pharmaceutical or biotechnology industry.
- Extensive experience performing vendor and third-party pharmacovigilance audits.
- Strong understanding of global pharmacovigilance regulations, including FDA, EMA, ICH, and other international regulatory requirements.
- Demonstrated ability to interpret audit protocols and strategically assess compliance against applicable requirements.
- Experience reviewing previous audits, inspection findings, and quality trends to develop risk-based audit strategies.
- Strong analytical, investigative, and report-writing skills.
- Excellent interviewing, communication, and stakeholder management abilities.
- Experience using electronic Quality Management Systems, including
Veeva Vault Quality or comparable platforms.
- Professional auditor certifications (ASQ CQA, RQAP, ISO Lead Auditor, or equivalent) are preferred.
- Preferred Experience
- Experience auditing complex global pharmacovigilance vendors and outsourced safety organizations.
- Ability to perform approximately
2 audits per month while managing multiple audit activities simultaneously.
- Experience supporting a high-volume global audit program involving hundreds of vendor audits annually .
- Multilingual capabilities are highly desirable to support worldwide audits and interactions with international stakeholders.
- Experience working across North America, Europe, Asia-Pacific, and other global regions.
- Travel Requirements
- Approximately
50–75% international and domestic travel .
- Ability to travel globally to vendor locations and company sites throughout the year.
- Core Competencies
- Strategic auditing and risk assessment
- Vendor qualification and oversight
- Global pharmacovigilance compliance
- CAPA evaluation and effectiveness verification
- Regulatory inspection readiness
- Cross-functional collaboration
- Excellent written and verbal communication
- Strong organizational and project management skills
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
Senior PV Auditor (3 Openings) in Cambridge employer: Kaztronix
Kaztronix is an exceptional employer that values its employees by fostering a collaborative and inclusive work culture, where continuous learning and professional growth are prioritised. With extensive opportunities for international travel and engagement in meaningful global projects, employees can enhance their skills while contributing to vital pharmacovigilance efforts. The company also offers competitive benefits and a commitment to diversity, ensuring a rewarding and supportive environment for all team members.
StudySmarter Expert Advice🤫
We think this is how you could land Senior PV Auditor (3 Openings) in Cambridge
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Kaztronix. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Kaztronix.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Kaztronix. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Kaztronix is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior PV Auditor (3 Openings) in Cambridge
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Kaztronix!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Kaztronix that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Kaztronix!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Kaztronix, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Kaztronix
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Kaztronix that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Kaztronix’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
