Pharmacovigilance Specialist – PV Reporting & Compliance

Cycle Pharmaceuticals

Cambridge

Hybrid

GBP 38,000 - 52,000

Full time

14 days+
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Benefits offered by this job

Competitive salary
Flexible hours
Bonus
Pension
Private health insurance
Life and Critical Illness Insurance
Team building events
Agile work environment

Job summary

Cycle Pharmaceuticals is seeking a Pharmacovigilance Associate to join our Cambridge team on a hybrid basis (minimum 3 days in the office). You will manage day-to-day PV activities and support safety science initiatives across products, ensuring favorable benefit-risk balance.

You will collaborate with Quality, Medical Affairs, Compliance and external PV partners, lead PV responsibilities on projects, and develop PV documentation and processes to maintain compliance and audit readiness.

Qualifications

  • Degree in a relevant science subject (Pharmacy, Chemistry, Biology).
  • Previous Pharmacovigilance experience and understanding of PV processes.
  • Experience writing aggregate reports (PSUR/PADERs) is desirable.
  • Excellent communication skills and ability to build relationships across the business.
  • Autonomous and proactive, yet a team player.
  • Strong attention to detail and quality.
  • Analytical, organisational and problem-solving abilities.
  • Willingness to learn new processes and follow procedures.
  • MS Office proficiency (Word, Excel, PowerPoint).
  • Ability to manage multiple tasks and prioritize workload.

Responsibilities

  • Drive preparation and review of PADERs and other aggregate PV reports.
  • Ensure accountability activities are audit-ready at all times.
  • Support launch activities and regulatory dossiers from PV perspective.
  • Review ICs from external partners prior to Health Authority submissions.
  • Support updates to SOPs and work instructions.
  • Develop Frequently Asked Questions for Cycle portfolio.
  • Respond to Medical Information inquiries.
  • Ensure documents shared with PV service providers are up to date.

Skills

PV experience
Attention to detail
Analytical
Organisational skills
Problem solving
Communication skills
Autonomous working
MS Office

Education

Degree in science (Pharmacy, Chemistry, Biology)

Tools

Word
Excel
PowerPoint

Job description

Cycle Pharmaceuticals is seeking a Pharmacovigilance Associate to join our Cambridge team on a hybrid basis (minimum 3 days in the office). You will manage day-to-day PV activities and support safety science initiatives across products, ensuring favorable benefit-risk balance.

You will collaborate with Quality, Medical Affairs, Compliance and external PV partners, lead PV responsibilities on projects, and develop PV documentation and processes to maintain compliance and audit readiness.

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