Medical / Pharmaceutical Scientist - Pharmacovigilance (m/f/d)

Beschreibung

We are growing, grow with us!
Want to work in a dynamic company with daily new challenges and opportunities? Then PharmaLex is your career opportunity!

PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products and medical devices. We support pharma companies throughout the entire product lifecycle, ensuring initial submissions and approvals as well as keeping compliance with pharmaceutical regulations worldwide. Our services extend way beyond market approval, providing high level strategic consultancy as well as hands-on work to extend product registrations into new markets across all regions of the world.

The success of our company grows with the excellent expertise and the high motivation of our employees.

If for you, your profession is not only a job but also a vocation and you enjoy working with people and in teams as part of a global organization, then you are very welcome to join us.

To strengthen our successful team, we are looking as of now (independent of location in Germany) for a:

Senior Manager Pharmacovigilance - QPPV (m/f/d)

Your Job

• 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
• 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.
• 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.

Your Profile

• Degree in Natural Science (Medicine, Pharmacy preferred) or equivalent and ideally also a doctorate degree
• A minimum of 5 years pharmacovigilance work experience 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
• Fluent in German and English
• Excellent oral and written communication skills

We offer you

• Diverse and challenging job
• Open and appreciative corporate culture
• Flexible working hours based on trust
• Possibility to work reduced number of hours
• Possibility to work from home
• Continuous development opportunities through knowledge and experience as well as training