PharmaSwiss, part of Bausch Health Companies, is one of the leading pharmaceutical companies that has been marketing its own and third-party products for many years now, while nurturing strong customer-oriented and consumer-centric approach in its everyday business. As a result, we are very proud of our strong reputation among healthcare professionals and consumers. Our goal is to make this leading position even stronger for years to come.
In our Global Pharmacovigilance and Risk Management team we are looking for:
Manager, Global Pharmacovigilance and Risk Management
Key responsibilities:
- Conduct signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked. Identify potential signals, validate and prepare signal assessment reports, or other related documents. Contribute to analyses in external databases (e.g. EVDAS) using data mining methods for detection and evaluation of safety signals
- Assist in aggregate safety data review
- Participate in the preparation of CCSI/CCDS
- Coordinate/co-author the finalization of documents such RMPs/REMS, PSURs and DSURs.
- Prepare responses to ad hoc requests from regulatory agencies
- Maintain pharmacovigilance expertise, understanding of international safety regulations and guidelines
- Develops, communicates, and implements best practices, SOPs, templates, work instructions, etc. as called for or specified in assigned tasks and projects
- Liaison with internal stakeholders, including members of Medical Affairs, Data Management, and Regulatory Affairs, in a matrix environment as needed for specific project needs/plans
Requirements:
- University degree in Medicine or Pharmacy
- At least 3-5 years experience in pharmacovigilance, including signal detection
- Fluency in English
- Computing skills: user requiring advanced literacy, knowledge of statistic software and use of drug safety database
Candidate's profile:
- Good planning and strong organizational skills, detail-oriented
- Excellent communication skills and ability to work within team and cross-functionally
- Understanding of international PV regulations including GVP and requirements (post-marketing regulations i preferred)
- Ability to manage complex tasks in a matrix environment
PharmaSwiss d.o.o.
PharmaSwiss, jedna od vodećih farmaceutskih kompanija u Srbiji, se bavi proizvodnjom i distribucijom sopstvenih i partnerskih proizvoda već dugi niz godina, negujući orijentisanost ka kupcima i stavljajući njihovo zadovoljstvo u prvi plan u svakodnevnom poslovanju. Zbog toga smo veoma ponosni na ugled i reputaciju koju imamo među zdravstvenim radnicima i potrošačima. Od 2011. PharmaSwiss je deo Bausch Health Companies Inc, globalne kompanije koja razvija, proizvodi i prodaje niz farmaceutskih proizvoda…