Interim Senior Manager, Pharmacovigilance (12 month FTC)
The Opportunity
We are seeking a skilled and experienced Interim Senior Manager in Pharmacovigilance to lead and oversee all drug safety and pharmacovigilance activities for an 12 month period, covering maternity leave. In this pivotal management role, you will ensure compliance with global regulations, maintain and enhance PV systems, and manage third-party service providers. You will also engage cross-functionally to contribute to Cycle’s growth plans and support our mission to deliver exceptional patient care.
Our Compan y
At Cycle, we believe Every Single Patient Matters. We pioneer innovative treatments and personalised support to improve the lives of those with rare diseases. By collaborating with patients, carers, and healthcare professionals, we transform cutting-edge science into practical solutions that fit seamlessly into daily life.
Our focus: optimising drugs, repurposing treatments, and reinstating generics. With advanced technologies, we deliver greater freedom and choice for patients, reimagining what’s possible in rare disease care.
Key Responsibilities
Pharmacovigilance Leadership:
* Manage and oversee day-to-day Pharmacovigilance (PV) activities, including Safety Data Exchange Agreement management, PV metrics maintenance, medical inquiries, periodic safety reporting, audit schedule maintenance, PSMF management and risk management.
* Oversee PV activities related to clinical trials and safety studies.
* Ensure adherence to GVP standards, including internal audits, training, and system updates.
* Act as Deputy UK QPPV, ensuring PV compliance.
* Support the creation and management of annual budgets.
Process Improvement:
* Enhance PV systems, including procedures and SOPs.
* Identify opportunities to insource PV activities and make recommendations.
Stakeholder Management:
* Collaborate with internal departments like Quality, Legal, and Regulatory Affairs.
* Manage third-party service providers to ensure compliance and optimal performance.
* Provide expert guidance and knowledge sharing to internal and external stakeholders.
People Management:
* Lead and mentor a team of PV professionals, fostering a supportive and growth-oriented environment.
* Oversee effective training and development for team members, ensuring continued professional development.
Qualifications and Skills
* Bachelor’s degree or higher in a Life Science-related discipline.
* Extensive experience in a Pharmacovigilance role within the pharmaceutical or CRO industry.
* Proven expertise in GVP compliance, PV system management, and stakeholder engagement.
* Exceptional project management, organisational, and communication skills.
* Strong negotiation and analytical abilities with a proactive, problem-solving mindset.
* High attention to detail and ability to manage competing priorities under pressure.
Additional req uirements
* Availability to commence in May / June 2025 for an 12-month interim period.
* Ability to work from the Cambridge office at least three days per week .
What can we o ffer to you
In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will enjoy all the benefits that brings:
* Competitive salary based on experience
* A collaborative high performing work environment
* Opportunity to join a fast growing and ambitious business
* Company pension scheme
* 100% employer paid membership for Private Health Insurance
* Life and Critical Illness Insurance
* Corporate Gym membership
* Regular team building events and an agile working environment
Applications
Cycle Pharmaceuticals embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.