Senior Scientific & Compliance PV Officer

ZipRecruiter; Wooburn Green; On-site; GBP 40,000 - 80,000

Job description

Job Description

We are recruiting for initially a period of ten months fixed term Senior Scientific & Compliance PV Officer with a potential to extend. The role reports to the Head of PV UK and is based in our offices near High Wycombe. You will support the UK pharmacovigilance department in overseeing the safety profile of the products approved in the UK and marketed globally. This is a great opportunity for someone looking to have a varied role different from your usual PV positions where you will be required to have strong hands-on expert scientific PV experience.

Key Responsibilities:

EXPERT SCIENTIFIC PHARMACOVIGILANCE

Authoring activities (prerequisites for the role):

• Perform literature review for ICSRs (weekly)
• Author aggregate safety reports (signal management reports, PSURs, RMPs) for assigned product portfolio (scientific and technical knowledge to be developed)
• Author responses to requests from MHRA
• Review changes made to the EURD list to assess impact on UK products

Perform downstream activities:

• Lead Risk Management Plan (RMP) work-sharing meetings and capture minutes
• Notification of signals to business partners/MHRA
• Create additional risk minimisation material
• Implement and oversee additional PV and/or Risk Minimisation activities
• Maintain metrics for distribution of aRMM
• Participate in consortiums if required
• Assess impact of changes to PI on RMP/aRMM/perform effectiveness check
• Review safety sections of SmPCs/PIL
• Prepare/attend/present at labelling meetings
• Assess impact of new reg intel on PI/RMP/aRMM for UK product/notification to MHRA
• Manage safety variation tracker & PIL implementation key dates

Support with interfacing activities:

• Provide PV input into quality/RA/commercial matters
• Support with new product implementation (NPI) projects

Additional compliance activities:

• Create and/or review local PV SOPs & review cross-functional UK procedures
• Assess impact of new/updates to HQ procedures on local UK affiliate PV procedures
• Maintain UK KPIs & review content of the PV book
• Create/review/comply with SDEAs
• Support with creating presentations for meetings (for instance Quality Management Review meetings)
• Keep up-to-date with local UK requirements and recommendations
• Support with PSUR submissions to the MHRA
• Maintain up-to-date the UK-PSSF & contribute towards the EU-PSMF
• Support with authoring deviations/CAPAs/change controls/note to files
• Manage CAPAs till closure
• Work closely with PVO and QA to ensure PQCs are handled properly
• Test the UK PV BCP annually

About You:

Experience/Education:

• Broad PV experience in the pharmaceutical industry - minimum 5 years
• Life science degree
• Experience of working in a global matrix organisation and collaborating at all levels including external authorities and partners.

Skills/Knowledge:

• Good understanding of GVP Modules and local UK regulations
• Excellent communication skills
• Problem-solving ability
• Adaptable and flexible team player
• Self-motivated
• Results-oriented with high attention to detail

We recognise the value of diversity in the workplace and provide equal opportunities for all. We are always open to discussing flexible working arrangements where this meets the needs of our business.

About Ethypharm Group:

Ethypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Our commitment is to improve patients' lives and make a positive impact on society and the 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. Ethypharm works closely with the authorities and healthcare professionals to ensure that its medicines are used appropriately and that patients have access to them.

To find out more about Ethypharm, visit http://www.ethypharm.com and follow us on LinkedIn.