Permanent, full-time position
Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering best-in-class drug treatment and support to the under-served rare disease patient community.
We focus on rare metabolic, immunological and neurological genetic conditions. Our patients typically require life-long treatment with life-saving medicine. Frequent and forever drug treatment can significantly impact the quality-of-life of patients. It can also impact the lives of their families and other caregivers. Cycle’s approach is to utilise the latest cutting-edge pharmaceutical technologies to deliver the required medicine, with the minimum impact on daily routines. Just as importantly, Cycle is committed to provide individualised support to patients, families, caregivers and the healthcare professional community. For more information please visit: www.cyclepharma.com
Cycle Pharmaceuticals is looking for an enthusiastic and talented team player to join its fast-growing Regulatory department based in Cambridge, UK as a full-time PVG Specialist. The role 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 and be directly in contact with 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. This is fantastic opportunity for a dynamic and competent PVG specialist, wanting to contribute to a growing business and an expanding team and wanting to enter or establish themselves in the pharmaceutical space.
Job Title: Regulatory Affairs – PVG Specialist
Cycle Company: Cycle Pharmaceuticals Ltd
Location: Broers Building, 21 JJ Thompson Ave, Cambridge, CB3 0FA
Position Summary: This full-time position sits within the Regulatory Affairs department.
Key Duties and Responsibilities:
- Contributing to the on-going enhancement of the Pharmacovigilance processes and Standard Operating Procedures including maintenance of the Pharmacovigilance System and EU/UK PSMF
- Responsible for the maintenance of the Safety Data Exchange Agreements with Cycle’s business partners
- Update Cycle’s PV partners’ audit schedule, organise and provide assistance during Cycle’s partners PV audits and Cycle’s internal audits
- Provide oversight of PV CAPAs through to resolution
- Support the preparation and review of PSURs, PADERs and RMPs
- Review of ICSRs received from external partners prior to submission to Health Authorities
- Organise pharmacovigilance 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
Qualifications & Skills:
Technical Skills and Experience:
- A minimum of a B.Sc. in a Life Sciences subject (Pharmacy, Chemistry, Biology or related discipline)
- Experience working in a Pharmacovigilance role and a good 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
- Good project management skills with a high level of attention to detail
- Ability to create strong working relationships across the organisation and with external partners
- Self-motivated, enthusiastic and hard-working
- Strong analytical, organisational and problem-solving skills
- Quality focused and high attention to details
What makes this role special:
- Seek to have a profound impact on patients and their families;
- Work across a range of different disease states;
- Opportunity for professional development and training;
- Help shape the culture and future of an emerging pharmaceutical company with a grand vision;
- Collaborate with a growing team of experienced professionals;
- Learn from a strong leadership team a with a proven history of success.
Working Conditions & Environment
The role will be based in our new Cambridge office but some travel to attend meetings may be required. We have an agile working policy which allows for a mixture of home, typically 2 days a week, and office-based working, and the flexibility to manage start and finish times around our core working hours of 10 am to 4 pm.
Employee Benefits at Cycle Pharmaceuticals
In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will be part of the Cycle ‘family’ and enjoy all the benefits that brings:
- Competitive salary based on experience
- 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
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.