Pharmacovigilance Associate

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 Associate to play a key role in the smooth running of our PV operations here at Cycle.

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’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. You’ll be the main PV representative at certain projects meetings and will take the lead on numerous PV responsibilities. Internally you will interact with key business areas such as Quality, Product Development, Medical Affairs and Compliance, the Hub, Finance, and Supply Chain.

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:

• Supporting safety data reconciliation activities.
• 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.
• Maintenance of the Safety Data Exchange Agreements with Cycle’s business partners.
• Ensure PV related Deviations and CAPAs are successfully closed and completed on time.
• 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.
• Drive the preparation and review of PADERs and other aggregate reports.
• Review of ICSRs received from external partners prior to submission to Health authorities.
• Support launch activities and preparation of regulatory dossiers from a PV perspective.
• 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:

• A minimum of a BSc. in a Life Sciences subject (Pharmacy, Chemistry, Biology or related discipline).
• A minimum of 2+ years’ experience working in a Pharmacovigilance role and a solid understanding of PV processes.
• Hands on experience in writing aggregate reports (e.g. PSUR and/or PADERs) is desired.
• Excellent communication skills and able to build strong 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 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.