Senior Manager - Deputy EEA QPPV (m/f/x) | Berlin | Pharma
In this position you will be a deputy from Pharmacovigilance for an exciting product portfolio of pharmaceuticals and medical products. You can expect a demanding and exciting challenge at one of the largest, internationally active players in the healthcare industry with a strongly growing portfolio at the Berlin location.
What will your tasks as Deputy EEA QPPV be?
- Knowledge of any conditions or obligations specified in the context of marketing authorisation(s) and other obligations
- Overview of the safety compliance profiles of medicinal products and any emerging safety concerns (e.g. signal detection)
- Knowledge of and adequate authority over the content of risk management plans (including risk mitigation measures)
- Ensure the required quality, including accuracy and completeness of pharmacovigilance data submitted to the competent authorities in the Member States and to the Agency.
- Ensure a full and prompt response to all requests from the competent authorities in the Member States and the Agency
- Provide input into the preparation of regulatory actions in response to emerging safety concerns
- Knowledge of the post-authorisation safety studies required by a competent authority, review and sign-off of protocols/final reports of studies.
- 24-hour contact point for competent authorities in Member States and the Agency, and focal point for pharmacovigilance inspections
- Lead/support other members of the QPPV office team in LPPV network and PSMF/PSSF activities.
- Ensure QPPV office with oversight of PV provider(s).
- Supervises and supports local PV officers/contact persons
- Establishes/maintains SOPs for the activities of the QPPV Office.
Your requirements as "Deputy EEA QPPV "?
- Degree in Medicine
- 5 years' experience in pharmacovigilance and skills of pharmacovigilance systems
- Adequate theoretical and practical knowledge of Pharmacovigilance activities
- Knowledge of EEA pharmacovigilance requirements
- Reside and operate in the EU / EEA
- Experience in clinical work preferable
- German and English: fluent in spoken and written
They will offer you?
- Unlimited contract with permanent position
- Home office: mind. 10 Days a month
- attractive benefits package
Information about our client:
Our client is a leading global healthcare company. The company makes contact lenses and surgical instruments as well as pharmaceuticals and has a unique international position with this range of products. The company employs more than 12,000 people worldwide, and more than 700 at the second largest company location in Berlin.
My contact details:
- Email: firstname.lastname@example.org
- Tel: 0049 (0) 89/26 20 09 25 (direct dial)
- Xing: https://www.xing.com/profile/Marlene_Inderhees/cv
- LinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/
Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!
I look forward to your application!