Senior Pharmacovigilance Scientist

Quanticate is seeking an experienced Senior Pharmacovigilance Scientist to take ownership of pharmacovigilance delivery across clinical development and post-marketing programmes. This is a hands-on, client-facing role with responsibility for leading safety operations on complex projects, overseeing regulatory safety reporting, and providing expert pharmacovigilance guidance throughout study set-up and delivery. You will play a visible role in safety surveillance and reporting activities, support inspections and audits, mentor junior colleagues, and help shape high-quality, efficient pharmacovigilance processes across the business.

• Manage the receipt, review, and lifecycle processing of safety cases from clinical studies, spontaneous reports, and published literature.
• Assess cases for data quality, completeness, privacy requirements, seriousness, expectedness, and reporting timelines.
• Prepare case narratives, issue and track follow-up requests, and ensure appropriate medical review.
• Enter and maintain accurate safety data within safety databases and tracking systems, including quality review of work completed by other team members.
• Prepare and submit expedited safety reports to regulatory authorities and other stakeholders, ensuring all submissions are compliant and on time.
• Act as the pharmacovigilance lead for assigned projects, providing operational oversight and serving as the main point of contact for clients.
• Develop and maintain study and project-specific safety documentation, including safety management plans and local reporting requirements.
• Support safety data reconciliation activities with clinical data management teams and ensure compliance with safety data exchange agreements.
• Coordinate safety file archiving and data transfer activities at the end of projects.
• Perform literature monitoring to identify reportable cases and emerging safety topics.
• Support signal review activities and contribute to periodic safety reports such as DSURs and PSURs.
• Track project metrics, support budget management, and assist with invoicing activities.
• Contribute to the development of internal procedures and support audit and inspection readiness.
• Provide guidance and day-to-day support to junior team members, including training on safety systems and regulatory processes.
• Ensure accurate and timely completion of timesheets and project records.
• Support business development activities when required, including proposal input and bid defence support.

Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers needs.

Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development

We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want - developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.

• Extensive experience in pharmacovigilance operations covering both clinical trial and post-marketing activities.
• Strong hands-on experience with individual case safety report processing, quality review, and regulatory submissions.
• Practical experience using ABCube, SafetyEasy, Oracle Argus, EudraVigilance for electronic reporting.
• Proven ability to lead pharmacovigilance activities on projects and interact directly with clients.
• Experience contributing to quality systems, including SOP development and audit or inspection support.
• Proficiency in industry standard safety databases, particularly Oracle Argus.
• Strong understanding of medical and scientific terminology.
• Excellent written and verbal communication skills.
• High attention to detail and a strong focus on quality and compliance.
• Strong organisational and time management skills, with the ability to work to tight deadlines.
• Confident user of Microsoft Word, Excel, and PowerPoint.
  
  Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid for courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance.
  
  

• Competitive salary (Open to discussion based on experience)
• Flexible working hours
• Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays)
• Medical Insurance for self and immediate family
• Gratuity
• Accidental Coverage
• Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing)