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Konkurs je istekao.

Risk Management Specialist




ugovor puno radno vreme

PharmaSwiss, part of Bausch Health Companies, 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

Primary Responsibilities:
• Conduct signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked
• Identify potential signals and validate
• Contribute to analyses in external databases using data mining methods for detection and evaluation of safety signals
• Assist in aggregate safety data review and preparation of signal assessment reports
• Coordinate/co-author the finalization of documents such Ad hoc requests from regulatory agencies and review regulatory documents such as RMPs/REMS, PSURs and DSURs
• 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)
• Provide strategic and proactive safety inputs into clinical development plans including protocols, CSRs, IB and informed consent
• Maintain pharmacovigilance expertise, understanding of international safety regulations and guidelines
• Develops, communicates, 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, Statistics, and Regulatory Affairs, in a matrix environment as needed for specific project needs / plans

Job Requirements:
• University degree in Medicine
• Minimum 2 years of relevant work experience in PV
• Fluency in English
• PC literacy

Konkurs je istekao.

PharmaSwiss d.o.o.

  • Srbija, Beograd, Batajnički drum 5A
  • PIB: 100057656
  • Matični broj: 17338480
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