EU-QPPV
- Applications are considered on a rolling basis
- Sweden
- As EU-QPPV for Clients perform, as contractually agreed, duties as laid down in Directive 2001/83/EC and the Guideline on Good Pharmacovigilance Practices (GVP)
- Expert for pharmacovigilance related questions within the department as well as for customers, national and international regulatory authorities
- Set-up, management, and participation in the operative part of pharmacovigilance systems
- Evaluation of the benefit-risk profile of drugs based on current scientific knowledge - this includes the creation of safety update reports PSURs (Periodic Safety Update Reports) and associated documents such as AdCOs (Addendum to the Clinical Overview), DSURs (Development Safety Update Reports), risk management plans and signal detection reports
- Preparation and review of Clinical Expert Statements regarding requests from competent authorities
- Set-up and maintenance of PV agreements of clients with their contractual partners.
- Close cooperation with the Marketing Authorization Holder as well as related departments and functions.
- Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the tasks of the EU-QPPV in connection with client procedures.
- Close cooperation of the EU-QPPV with the respective Deputy function.
- As EU-QPPV, provide the Deputy EU-QPPV with information on relevant current PV activities.
- Regular monitoring and evaluation of changes in pharmacovigilance regulations regarding impact on Pharmacovigilance System.
- Within PharmaLex: close cooperation with the International Service Lead (ISL) QPPV and the Head of Service Area PV Systems Outsourcing.
- Participation and support in Consultative Value Selling activities together with other internal and external client and PharmaLex stakeholders (e.g Commercial, Key Account Managers, PMs), specifically provision of subject matter expertise
Skills & Requirements
- Degree in Natural Science (Medicine, Pharmacy preferred) or equivalent and ideally also a doctorate degree
- A minimum of 10 years pharmacovigilance work experience ideally within a service provider or proven equivalent experience in global pharmacovigilance systems (all areas, not limited to case processing).
- Knowledge of relevant legislative and non-legislative guidelines of pharmacovigilance
- Familiarity with industry principles of pharmacovigilance
- Ability to organize operations and take over project management
- Ability to analyse and solve problems and to develop pragmatic solutions within regulatory framework
- Ability to balance client concerns and company interests
- Ability to assimilate and analyse information rapidly
- Ability to adjust rapidly to new, unknown, challenging situations
- Autonomous, concentrated and high-quality work
- Sense of responsibility
- Fluent in German and English
- Excellent oral and written communication skills
- Works and resides within the EU/EEA
About the company
PharmaLex is one of the leading service companies for the pharmaceutical industry globally and is specialized in all aspects of drugs and medical devices approval, of the development to market and any action of effective product maintenance. PharmaLex values includes international mindset, growth & learning, collaboration, quality focus, dynamic working approach and integrity & respect.
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