Global Pv Specialist

vor 6 Monaten

Munich, Deutschland Acino Pharma Vollzeit

**Munich, Germany**:
Acino AG, based in Munich, is part of the Acino Group, a Swiss pharmaceutical company and a leader in advanced drug delivery technologies with its headquarters in Zurich.

Acino out-licenses its own products and manufactures third party products mainly for the European market. In its commercial operations, Acino has a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America. We operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.

We are constantly expanding our market position with a future-oriented international business strategy. Therefore, we are looking for a dedicated and motivated person to strengthen our team in Munich, Germany.

**Global PV Specialist (w/m/d)**

Major Accountabilities:

- Responsible for the oversight of PV activities and signal management
- Internalizing of PV activities from external service providers and ongoing process improvement
- Planning and preparation of aggregate reports (PSURs, ACOs), RMPs and QC
- Evaluates potential new safety concerns and brings them to Global Safety and Labelling Committee (GSLC)
- Implementation and oversight of RMP activities
- Supports of local PV processes within PV network
- Supports Medical Affairs during preparation of educational materials
- Provides risk assessment from PV perspective
- Prepares responses to deficiency letters and Competent Authorities requests
- Maintenance of global trackers/folders
- Supports SDEA management
- Prepares, monitors and updates key activities plan to ensure effective capacities utilization and KPIs fulfilment (e.g. PSUR submission)
- Supports Global PV operations, ensure filing and archiving of PV documents, and organize and participate PV meetings
- Cooperates with QA regarding PV compliance and inspection readiness
- Identifies the need for new pharmacovigilance procedures and SOPs, and participates in development, revision and implementation
- Participating or Leading PV Improvement streams

Your Profile:

- Life science master degree equivalent
- Pharmacovigilance experience is required across the product lifecycle
- Significant experience in pharmacovigilance legislation and processes
- In depth knowledge of pharmaceutical and pharmacovigilance processes
- Proved experience of Global PV activities, SOPs management, PSMF updates, DL responses
- English (oral and written) fluent

We offer a very attractive working environment within a highly motivated team with excellent working conditions. You can expect the following benefits:

- An international working environment in a constantly growing company
- A quality and customer-oriented environment
- A motivated, agile and service-oriented team
- Interesting and highly diversified tasks that provide a broad basis for your future career in the pharmaceutical industry
- Attractive salary
- Flexible working hours (possibility of home office)

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If you are interested in this role we are looking forward to hearing from you.

**Further Information**:
Our team is happy to respond to any questions about the role or Acino you may have:
We are looking forward to hearing from you.

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