Pharmacovigilance Associate (f/m/d)
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.
Pharmacovigilance Associate (f/m/d)
In this role, you will be responsible to support Acino global PV and local CH & DE PV from an operational and administrative point of view, to ensure PV training compliance for the CH & DE Acino staff including documentation and to provide source data for PSMFs and PV documents (i.e. PSUR, RMP, ACO, PV statements). You are responsible to support with vendor oversight, to provide PV source data, to organize and document PV trainings, meetings and to request tracking interacting with responsible stakeholders.
- Responsible for organization of PV Operational meetings, maintaining documentation, tracking decisions and completion of tasks by responsible PV stakeholders, support with follow up on actions and requests
- Responsible for PV training compliance for CH & DE Acino staff including documentation
- Provision of source data for PSMFs and PV documents (i.e. PSUR, RMP, ACO, PV statements)
- Responsible for organization, preparation and documentation of ACINO Pharma AG signal detection meetings including CH local literature search
- In charge of archiving, tracking and e-storage of PV-related documents, records, contracts, and communications including uploading into databases
- Responsible for collection of signatures and provision of finalized contracts/PV documents to relevant functions
- Maintenance of Global PV trackers (i.e. SDEAs, PSURs, RMPs, RSI, PV regulatory intelligence)
- Responsible for SDEA oversight tracker update
- Cross-functional collaboration (regional QA, PV & RA, GRA responsible person for the products under responsibility, Commercial, Global Medical Affairs, others)
- Provision of regulatory documents from an external archive located near Basel to Global Medical Affairs, when needed (very limited travel required)
- Responsible for upload of PV related invoices into Acino’s financial system
- Assist in writing Standard Operating Procedures
- Life science degree or equivalent preferred but not required
- Experience in generics industry and in pharmacovigilance (GVP) preferred but not required
- Excellent planning and organizational skills with capability to prioritize tasks and adhere to timelines highly required
- Prompt and accurate performance of tasks and responsibilities
- Structured and quality-conscious way of working
- Able to work in an international and interdisciplinary environment
- Team player with good communication and negotiation skills
- Target oriented, multi-tasking and able to work under pressure
- Fluent in English (written and oral) is a must; German is highly preferred (any further languages are an advantage)
We offer a very attractive working environment within a highly motivated team with excellent working conditions. You can expect the following benefits:
- A job in a crisis-proof pharmaceutical company
- 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.
Note that only direct applications via our HR system (follow the link above) will be considered.