Regulatory Affairs Administrator - PV

Hiring By - Biostaffic

 BioPharma

United Kingdom

Job Highlights

Not Disclosed

Entry level

Posted 4 months ago
Job details

The Opportunity


Cycle Pharmaceuticals is looking for an enthusiastic and talented team player to join its growing Regulatory Affairs Department as a Regulatory Affairs Administrator - PV.


The ideal candidate will be responsible for a range of Pharmacovigilance administration processes and procedures and for managing the day-to-day administrative activities and supporting the maintenance and development of Cycle’s pharmacovigilance systems.


You will be working across different therapeutic areas including metabolic, immunology and neurology. This role interacts internally with key areas such as Quality, Medical Affairs and Compliance, and Supply Chain. Externally this position interacts with Pharmacovigilance subcontractors and Cycle’s 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.


Job Title: Regulatory Affairs Administrator - PV

Cycle Company: Cycle Pharmaceuticals Ltd

Position Summary: This is a full-time position within the Regulatory Affairs department, working in our Cambridge office.


What you will be doing

• Provide administrative assistance with safety data exchange.

• Supporting safety data reconciliation activities.

• Prepare and organise periodic meetings with QPPV and circulate minutes/actions.

• Support on general administrative tasks such as setting up meetings and taking minutes.

• Ensure audit readiness: ensuring that all the accountable activities are audit ready at any time.

• Support review and updates to relevant SOPs and WIs.

• Monitor the PV inbox daily.

• Provide administrative assistance during Cycle’s internal audits and partner PV audits.

• Provide support in pharmacovigilance metrics drafting, following written procedures and instructions.

• Perform periodic reconciliation of Cycle´s logged complaints with PV service provider, following written procedures and instructions.

• Ensuring documents shared on Box with PV service provider remain up to date.

• Perform periodic checks of EMA EURD.

• Complete weekly phone line monitoring.

• Update and maintain PV-related spreadsheets, as assigned by your manager.

• Support monitoring activities related to Health Authority Commitments.


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:

• Minimum of 2+ years of administration experience, preferably in a regulated industry.

• BSc in a relevant scientific degree or equivalent experience working in a relevant scientific field.

• Proficient in ensuring that all the documentation required is in order, up to date and correct.

• Excellent written and oral communication.

• Ability to work in a proactive and autonomous manner, as well as being part of a team.

• Good time management skills with a high level of attention to detail and quality.

• Ability to create and maintain strong working relationships across the organisation and with external partners (where applicable).

• Self-motivated, enthusiastic and hard-working.

• Strong analytical, organisational and problem-solving skills.

• Willing to learn new processes and work to procedures set within the business.

• Proficiency with the Microsoft Office suite, including Word, Excel, Access and PowerPoint.

• Ability to manage a range of tasks at any one time and prioritise own workload.


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 emerging 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.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • United Kingdom

Experience:

  • Entry level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 15, 2024
Company Overview
Cycle Pharmaceuticals
Cycle Pharmaceuticals

Current Openings: 0

Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering best-in-class drug treatments and services to the under-served rare disease patient community. We focus on rare metabolic, immunological and neurological genetic conditions. Cycle is headquartered in Cambridge, UK and has offices in Boston, Mass. (USA). For more information, please visit www.cyclepharma.com and follow us on Twitter, LinkedIn and Facebook.
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