Pharmacovigilance Administrator
Cycle Company: Cycle Pharmaceuticals Ltd
Position Summary: This full-time position is within the Pharmacovigilance team working in our Cambridge office on a hybrid basis (minimum 3 days in the office).
Are you detail-driven and an organised person who is looking for an opportunity to work within the pharmaceutical industry? We're looking for a Pharmacovigilance Administrator to play a key role in the smooth running of our PV operations here at Cycle.
This is an important position within the team as, you'll manage day-to-day pharmacovigilance administrative activities, support the development and upkeep of our PV systems, and ensure compliance with regulatory standards.
You’ll collaborate closely with various other departments in the business while also liaising with external PV subcontractors and strategic partners to keep our safety systems sharp and responsive. This is an exciting opportunity for someone who has strong administration skills with a keen interest in the pharmaceutical industry and a passion to learn more about PV.
Our Company
At Cycle, we believe that Every Single Patient Matters. This is at the heart of why we work and were looking for people to join our team who 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.
Our core focus therapeutic areas include rare metabolic, immunological, and neurological genetic conditions, where we improve existing drugs, repurpose them for new uses, and bring generics back to market. Using cutting-edge drug delivery technologies, we enhance the efficiency of treatments, offering patients greater freedom and choice.
If you want to know more about what we do then, why not check out our website below and take a look at some of our patient stories
Patient Stories - Cycle Pharma
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 Pharmacovigilance inbox.
- 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 with PV service provider remain up to date.
- Perform periodic checks of EMA EURD List.
- Complete weekly phone line monitoring.
- Update and maintain PV-related spreadsheets.
- Support monitoring activities related to Health Authority Commitments.
The following skills and experience will be important in helping you set up to succeed and thrive in this role:
- Previous administration experience, preferably within a regulated industry.
- Life Science degree would be beneficial and support you in this role.
- Excellent communication skills to build relationships across the business.
- 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.
- 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 we can offer you:
- Competitive salary based on experience
- Flexible working hours with core hours 10am - 4pm
- 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
Diversity and Inclusion statement:
At Cycle Pharmaceuticals, we are committed to creating an inclusive, respectful, positive and diverse workplace.
We do not discriminate on the basis of race, colour, religion, gender, age, disability, or any other protected characteristic. We actively support and embrace diversity, and we are working to build a team that reflects a wide range of backgrounds and perspectives.
We value your unique contributions and encourage you to join us in shaping a more inclusive future. If you require any reasonable adjustments - whether during the application process or in the workplace - we will be happy to support your needs. At Cycle, equality, inclusion, and respect are at the core of everything we do. We fully comply with all applicable employment laws, including those related to non-discrimination, work authorization, and employment eligibility verification.
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