Scientific Compliance Officer
2 days ago
**Job Overview:**
Ethypharm is a leading mid-sized global pharmaceutical company looking for a highly skilled Scientific Compliance Officer to join its team. This exciting opportunity offers the chance to work in a dynamic environment, supporting the pharmacovigilance department in overseeing the safety profile of products approved in the UK and marketed globally.
**About the Role:**
We are seeking a talented individual with a broad PV experience in the pharmaceutical industry, minimum 5 years, who can bring their expertise in GVP Modules and local UK regulations to our team. The successful candidate will have excellent communication skills, problem-solving ability, adaptability, flexibility, self-motivation, and results-orientation with high attention to detail.
**Key Responsibilities:**
The role will involve authoring activities such as literature reviews for ICSRs, aggregate safety reports, responses to requests from MHRA, and reviewing changes made to the EURD list. Downstream activities include leading Risk Management Plan (RMP) work-sharing meetings, notification of signals, creating additional risk minimisation material, implementing and overseeing PV and/or Risk Minimisation activities, maintaining metrics for distribution of aRMM, participating in consortiums, assessing impact of changes to PI on RMP/aRMM, reviewing safety sections of SmPCs/PIL, preparing/attending/presenting at labelling meetings, assessing impact of new reg intel on PI/RMP/aRMM for UK product/notification to MHRA, managing safety variation tracker & PIL implementation key dates.
Additionally, the role will involve interfacing activities such as providing PV input into quality/RA/commercial matters, supporting with new product implementation (NPI) projects, creating and/or reviewing local PV SOPs, assessing impact of new/updates to HQ procedures on local UK affiliate PV procedures, maintaining UK KPIs, reviewing content of the PV book, creating/reviewing/complying with SDEAs, supporting with creating presentations for meetings, keeping up-to-date with local UK requirements and recommendations, supporting with PSUR submissions to the MHRA, maintaining up-to date the UK-PSSF & contributing towards the EU-PSMF, supporting with authoring deviations/CAPAs/change controls/note to files, managing CAPAs till closure, working closely with PVO and QA to ensure PQCs are handled properly, testing the UK PV BCP annually.
**Salary Information:**
The estimated annual salary for this position is around £50,000-£60,000 depending on experience.
**Work Environment:**
Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations. Our six production sites located in France, the UK, Spain, and China have expertise in injectables and complex oral solid forms. With a global presence in 68 countries, the company markets its products directly in Europe and China, and has strategic partnerships in the EMEA, NA, LATAM and APAC markets.
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