Cycle Pharma

Cambridge, UK • Posted on 4th Jul 2024

Senior Pharmacovigilance Associate (Cambridge, UK)

The Opportunity

Cycle Pharmaceuticals is looking for an enthusiastic and talented team player to join its growing Product Development Department as a Senior Pharmacovigilance Associate.

The ideal candidate will be a team player and self-starter eager to learn and able to multitask across multiple projects. You will be responsible for managing the day-to-day pharmacovigilance activities and supporting the maintenance and development of Cycle’s pharmacovigilance systems. Within this position you will be able to develop a broad experience across different Pharmacovigilance areas.

You will be working across different therapeutic areas including metabolic, immunology and neurology. Internally you will interact with key business areas such as Quality, Product Development, Medical Affairs and Compliance, the Hub, Finance, and Supply Chain. Your external interactions will be with the company’s QPPVs and external partners.

The Cambridge team is relatively small but highly dynamic, and the work environment is representative of an expanding company, hence requiring an adaptive and pragmatic mindset. Coaching and mentoring to support continuous learning and professional development will be provided and tailored to individual needs.

Our Company

At Cycle, we believe that Every Single Patient Matters, this is at the heart of why we work, and we’d love for you to share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen.

We are a pioneering pharmaceutical company, reimagining how drugs and services can benefit patients with rare disease to make their lives easier and improve their quality of life. Cycle, as a company, works closely with patient groups and healthcare professionals to understand the unmet needs of patients and their carers. By collaborating with academic communities and using the latest cutting-edge pharmaceutical technologies, we translate innovations into medicinal products that patients and caregivers actually desire. We deliver the required medicine with the minimum impact on daily routines and, just as importantly, provide individualized support services to patients, families, carers and the healthcare professionals community.

Cycle has three core areas of pharmaceutical development and work across rare metabolic, immunological and neurological genetic conditions: improving drugs – optimizing an existing drug; repurposing drugs – creating a new indication for an existing drug; and generics – reinstating generic drugs, previously available in the market. These three areas of focus are underpinned by formulation technology – using new drug delivery technologies to improve the efficacy and effectiveness of drugs, allowing us to give patients greater freedom and choice.

Role Details
Job Title: Senior Pharmacovigilance Associate
Cycle Company: Cycle Pharmaceuticals Ltd
Position Summary: This is a full-time position within the Regulatory department, working in our Cambridge office.

What you will be doing

Your key responsibilities will include:
• Drive the on-going enhancement of the Pharmacovigilance (PV) processes and Standard Operating Procedures including maintenance of the PV System and EU/UK PSMF.
• Maintenance of the Safety Data Exchange Agreements with Cycle’s business partners.
• Contribute to PV risk assessment of Cycle’s partners by sharing GVP questionnaires, assessing the information received and creating and maintaining an audit plan.
• Organise and provide assistance during Cycle’s partners PV audits and Cycle’s internal audits.
• Ensure PV related Deviations and CAPAs are successfully closed and completed on time.
• Drive the preparation and review of PSURs, PADERs and RMPs.
• Review of ICSRs received from external partners prior to submission to Health Authorities.
• Support preparation of responses to Medical Information enquires received.
• Organise medical information and PV trainings for internal and external stakeholders.
• Creation and review of PV metrics and following up on non-compliance through to resolution.
• Application of pharmaceutical regulations and new guidelines/policies relevant to pharmacovigilance.
• Support launch activities and preparation of regulatory dossiers from a PV perspective.
• Support PV activities for Clinical Trials and Safety Studies.

You will also:
• Act as a mentor to junior colleagues, and support the creation of an environment in which people are encouraged and able to model positive behaviours around collaboration and communication.
• Attend team meetings and engage with internal and external stakeholders providing support.
• Proactively maintain knowledge of relevant PV guidance and provide the wider department with updates on any changes to relevant legislation and guidelines.
• Act as primary contact for internal questions from other departments.
• Support the department leadership to develop and improve procedures and processes used by the wider department.

What will enable you to thrive

The following skills and experience will be important in helping set you up to succeed and thrive in this role.
• A minimum of a B.Sc. in a Life Sciences subject (Pharmacy, Chemistry, Biology or related discipline).
• A minimum of 2+ years’ experience working in a Medical Information and Pharmacovigilance role and a solid understanding of PV processes.
• Knowledge of EMA GVP Modules.
• Hands on experience in writing aggregate reports (e.g. PSUR and/or PADERs).
• Understanding of ICSR processing and SDEAs.
• Demonstrable aptitude for IT packages such as Word, Excel, Access & PowerPoint.
• Excellent written and oral communication.
• Ability to work in a proactive and autonomous manner, as well as being part of a team.
• Excellent time management skills with a high level of attention to detail.
• Ability to create and maintain strong working relationships across the organisation and with external partners.
• Enthusiasm and personal initiative to solve problems, a self-starter with ability to work unsupervised.
• Able to deliver against target dates.
• Strong analytical, organisational and problem-solving skills, and the ability to think-outside the box.
• Quality focused and high attention to detail.
• Result-oriented.

What makes this role special

• Seek to have a profound impact on patients and their families.
• Work across a range of different disease states.
• Mentoring, coaching and training that will give you the opportunity for personal and professional development.
• Help shape the culture and future of an growing pharmaceutical company with a grand vision.
• Work with a growing team of experienced professionals.
• Learn from a strong leadership team with a proven history of success.

What can we offer 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
• Performance based bonus
• 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.

Please send your application and cover letter to: