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Konkurs je istekao.

Risk Management Specialist

PharmaSwiss

Beograd

07.06.2023.

ugovor puno radno vreme

PharmaSwiss, part of Bausch Health, is one of the leading pharmaceutical companies in Serbia, 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.

We are looking for dynamic and responsible candidates for the open vacancy in our global PV & Risk Management Team:

Risk Management Specialist
Location: Belgrade

Primary Responsibilities:

•    Provide support in the preparation of CCSI/CCDS for newly approved products, products in late-stage development, and established company products (both generic and proprietary)
•    Participate in preparation/update of PV documents such as RMPs
•    Assist in aggregate safety data review
•    Conduct signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked. Identify potential signals, validate and prepare signal assessment reports. Contribute to analyses in external databases (e.g. EVDAS) using data mining methods for detection and evaluation of safety signals
•    Prepare responses to ad hoc requests from regulatory agencies
•    Assist in the review and finalization of REMS documents
•    Maintain pharmacovigilance expertise, understanding of international safety regulations and guidelines
•    Develop, communicate, and implement best practices, SOPs, templates, work instructions, etc. as called for or specified in assigned tasks and projects
•    Liaison with internal stakeholders, including members of Clinical, Medical Affairs, Data Management, and Regulatory Affairs, in a matrix environment as needed for specific project needs/plans

Job Requirements:

•    University degree in Medicine or Pharmacy
•    Minimum of 2 years of experience in pharmacovigilance and at least 1 year of experience in RMP and/or CCDS area
•    Understanding of international pharmacovigilance regulations including GVP and requirements (post-marketing regulations is preferred)
•    Thorough knowledge of pharmacovigilance, signal detection and risk management
•    Knowledge of statistical software and use of drug safety database

•    Fluency in English
•    Computing skills: user requiring advanced literacy (Microsoft Office applications, Adobe Acrobat)
•    Excellent communication skills and ability to work within the team and cross-functionally
•    Ability to manage complex tasks in a matrix environment

 

Konkurs je istekao.

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…

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