EU QPPV – Drug Safety Physician

Location: Germany

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Hessen Germany.

It is a well-known pharmaceutical company that is constantly growing and improving itself.

ROLE DESCRIPTION

The EU QPPV Office Safety Physician reports to the EU Qualified Person for Pharmacovigilance (EU QPPV), thereby providing support to the EU QPPV in undertaking his/her responsibilities.

The person will support the EU QPPV in making decisions and recommendations to ensure MAHs in Europe are compliant with the requirements of EU PV Legislation, and in ensuring that Otsuka has appropriate systems for pharmacovigilance compliance and product safety management globally.

The person will work collaboratively with other departments (such as all other functions in Pharmacovigilance, Regulatory Affairs, Quality Management and Quality Assurance) within the company to address and resolve issues relating to products and PV processes.

The person will provide guidance to key stakeholders in addressing issues related to the PV System.

RESPONSIBILITIES

• Be available as a back-up to the EU QPPV.
• Acting as a back-up contact point to the EU QPPV for all pharmacovigilance matters and safety governance issues, including audits and inspections, for products globally.
• Participate in internal and external groups for networking, intelligence gathering and input, as agreed with the EU QPPV.
• Contribute to the maintenance of the PSMF, as appropriate.
• Act as ambassador for PV governance within and outside the company.
• Involvement in the review of key regulatory documents and programs, such as PSURs, RMPs, PASS and CAPA’s, prior to approval by the EU QPPV.
• Overview of safety profiles and emerging safety concerns
• Maintain an awareness of developments in the safety profiles of the companies' products.
• Engage with the relevant functions in the development and review of key regulatory documents related to PV for the company.

REQUIREMENTS

Education/Qualifications
• MD Physician.
• Relevant of experience in pharmacovigilance.
• Excellent working knowledge of 2010 EU PV legislation requirements.
• Familiarity with global pharmacovigilance requirements.

Technical skills & experience
• Strong knowledge of relevant Pharmacovigilance legislation and regulations.
• Extensive experience in Pharmacovigilance preferably as a therapeutic area lead or safety physician at a global level.
• Excellent verbal and writing skills with experience writing, editing and compiling regulatory experience.
• Understanding of the processes associated with Safety, Regulatory and Clinical development.
• Demonstrated ability to lead projects, initiatives, or programs across multiple departments, regions and business units and external stakeholders.
• Experience providing deliverables for health authorities (including but not limited to the US FDA, EMA, MHRA) is preferred.
• Technical proficiency, including skills in use of common desktop tools ( MS Word, MS Excel, MS Project, Powerpoint, Visio, etc.)
• Experience with typical tools used in Pharmacovigilance for example CAPA management system, safety database etc.


Personal skills:
• Strong team player, with excellent communication and organizational skills
• Able to work independently and also within a tea environment
• Able to travel to other European and international locations (UK/USA) as required (+/- 10%)

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rosa Markus.