A leading and global regulatory outsourcing consulting services to Life Sciences companies is currently recruiting an EU QPPV. Based in Germany, this is an exciting opportunity to bring expertise and skills to an established and in-demand company.
- Reports to the Head of Pharmacovigilance in Germany and acts as Senior PV officer.
- Oversees junior PV staff (training and mentorship).
- Acts as EU QPPV or GPO for different customers across Europe.
- Contributes to the preparation and design of new PV projects for the company, liaising with our European offices in UK, France and Italy.
- Serves as a Project lead for key company clients this includes, customer facing and liaising with clients, project managers and internal staff to ensure delivery of PV services.
- Ensures that all assigned projects are set-up in line with the client, the PVG standard operating procedures (SOPs)/working practice documents (WPD) and relevant guidelines.
- Manages the CAPA process for project non-conformances follow up on actions and liaise with Quality Dept.
- Complies with the company's policies and procedures to meet statuary, quality and business requirements within the overall strategy and objectives.
Skills and Requirements:
- Bachelor's or higher graduate degree in a science related field.
- 7 years of pharmacovigilance experience.
- Broad knowledge of PV, especially post marketing (PSMF, signal detection reports, EV DAS, MLM).
- Audit experience is desirable.
- Experience with case handling, in signal detection and literature processes.
- Quality oriented and attention to detail.
- Ability to assist on PV proposal bids and attend customer facing telephone and face to face meetings.
- Past GPO stufenplanbeauftragter experience required and previous EU QPPV experience is desirable.
- Experience with handling PSMF updates (Local or Global) desirable.
- Knowledge with signal detection process and EV DAS desirable.
- In-depth knowledge of GVP and local legislation.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
- Fluent in German and English for daily contacts.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Andreas Bartelt at email@example.com or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.