Senior Pharmacovigilance Associate
6 days ago
Cycle Pharmaceuticals is seeking a highly skilled and experienced Pharmacovigilance Associate to join its growing Product Development Department in Cambridge, UK.
The ideal candidate will be a team player and self-starter eager to learn and able to multitask across multiple projects. As a Pharmacovigilance Associate, you will be responsible for managing the day-to-day pharmacovigilance activities and supporting the maintenance and development of Cycle's pharmacovigilance systems.
Key Responsibilities- Pharmacovigilance Process Enhancement: Drive the on-going enhancement of the Pharmacovigilance (PV) processes and Standard Operating Procedures, including maintenance of the PV System and EU/UK PSMF.
- Safety Data Exchange Agreements: Maintain the Safety Data Exchange Agreements with Cycle's business partners.
- Pharmacovigilance Risk Assessment: Contribute to PV risk assessment of Cycle's partners by sharing GVP questionnaires, assessing the information received, and creating and maintaining an audit plan.
- Pharmacovigilance Audits: Organise and provide assistance during Cycle's partners PV audits and Cycle's internal audits.
- Deviation and CAPA Management: Ensure PV related Deviations and CAPAs are successfully closed and completed on time.
- PSUR, PADER, and RMP Preparation: Drive the preparation and review of PSURs, PADERs, and RMPs.
- ICSR Review and Submission: Review of ICSRs received from external partners prior to submission to Health Authorities.
- Medical Information Support: Support preparation of responses to Medical Information enquires received.
- Training and Development: Organise medical information and PV trainings for internal and external stakeholders.
- Quality Metrics and Compliance: Creation and review of PV metrics and following up on non-compliance through to resolution.
- Regulatory Compliance: Application of pharmaceutical regulations and new guidelines/policies relevant to pharmacovigilance.
- Launch Support and Regulatory Dossiers: Support launch activities and preparation of regulatory dossiers from a PV perspective.
- Clinical Trials and Safety Studies: Support PV activities for Clinical Trials and Safety Studies.
- Education: A minimum of a B.Sc. in a Life Sciences subject (Pharmacy, Chemistry, Biology, or related discipline).
- Experience: A minimum of 2+ years' experience working in a Medical Information and Pharmacovigilance role and a solid understanding of PV processes.
- Knowledge: Knowledge of EMA GVP Modules, hands-on experience in writing aggregate reports (e.g., PSUR and/or PADERs), understanding of ICSR processing and SDEAs.
- Skills: Demonstrable aptitude for IT packages such as Word, Excel, Access, and PowerPoint, excellent written and oral communication, ability to work in a proactive and autonomous manner, as well as being part of a team.
Cycle Pharmaceuticals is 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. We work 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 provide individualized support services to patients, families, carers, and the healthcare professionals community. Cycle has three core areas of pharmaceutical development: improving drugs, repurposing drugs, and generics. These 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.
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