Qppv Office Manager

vor 4 Wochen

Schweiz Modis Vollzeit

For our client in Bern, Modis is currently looking for a QPPV Office Manager with 100% remote working possibility on a 12 month project in an English-speaking position.

**Brief Job Description**:
The QPPV Office Manager provides strategic professional support for the business-critical regulatory role of the Qualified Person responsible for Pharmacovigilance (QPPV). This includes development, continuous assessment, and improvement of processes to ensure that the QPPV can fulfil his/her legal obligations with regards to oversight of the client’s worldwide pharmacovigilance (PV) system.

The role interacts with multiple GCSP functions and other interface functions on a global basis to ensure implementation strategy of required changes to the PV system is aligned across different functions. The QPPV Office Manager is responsible for the establishment and maintenance of regulatory required global documents and for the oversight over the development and maintenance of the local regulatory documents as required by national PV legislations.

**General Information**:

- Location: client office is in Bern, Switzerland
- Workload: 100%, Monday to Friday, 40 hours per week
- Home-office: 100% home-office is possible, however must be home office from Switzerland
- Type of employment: temporary contract
- Duration: 12 months
- Start date: ASAP

**Main Responsibilities**:

- Supports the QPPV / Deputy QPPV to ensure appropriate oversight on the company’s entire PV system.
- Provides a significant contribution to compliance with global regulations, guidelines, and standards.
- Establish and ensure maintenance of key regulatory required documents, i.e., the global PSMF in line with international regulations, guidelines, and internal standards.
- Contributes to the development of an end-to-end PSMF management process and thus supports the local QPPV (LQPPV) / Safety Officer role nominated at local level in the PSMF management activities.
- Supports the establishment and maintenance of the LQPPV network in collaboration with the QPPV and GCSP Regions. Contributes to efficient information flow within the LQPPV network.
- Develops, maintains and reviews procedural documents related to QPPV/QPPV Office processes.

**Qualifications**:

- Bachelor or Master´s Degree in a life science discipline (e.g., Pharmacy)
- 3-5 years Pharmacovigilance or Regulatory experience in multinational pharmaceutical industry
- Holistic understanding of the global PV system, its quality system, and the dependencies of PV activities across the company
- In depth knowledge of international (especially EU/EEA) standards and regulatory requirements/regulations and processes related to pharmacovigilance
- Experience in administration of complex data sets
- Excellent written and verbal communication skills in English

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