sharing the costs of sports activities
Global Pharmacovigilance and Risk Management Specialist
Bausch Health Poland Sp z.o.o.
Warszawa
Warszawa, Masovian- offer expired 3 months ago
- contract of employment
- full-time
- specialist (Mid / Regular)
- full office work
- remote recruitment
Your 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.
Our requirements
Higher level of education/qualification in life science discipline or relevant experience, preferable medicine, pharmacy, veterinary degree.
Minimum of 2 years of experience in pharmacovigilance and at least 1 year of experience in RMP and/or CCDS area.
Good planning and organizational skills.
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.
Ability to work under pressure in order to meet tight deadlines.
Ability to manage complex tasks in a matrix environment.
Strong organizational skills, detail oriented, ability to adapt in a fast paced constantly changing environment.
Computing skills: user requiring advanced literacy (Microsoft Office applications, Adobe Acrobat).
Excellent communication skills and ability to work within the team and cross-functionally.
Fluency in English.
What we offer
Working in global position.
Pleasant working atmosphere in international environment.
Opportunity for learning and growing in positive and supportive team of professionals.
Benefits
private medical care
sharing the costs of foreign language classes
extra social benefits
sharing the costs of tickets to the movies, theater
holiday funds
Bausch Health Poland Sp z.o.o.
Bausch Health Companies are part of the fastest-growing international pharmaceutical companies aimed at providing quality products in the field of healthcare. We are focused on fulfilling its commitments to patients, healthcare professionals, shareholders, and society as a whole.
We develop manufacture and offer a wide range of branded and generic pharmaceuticals and medical devices in over 90 countries and regions. Bausch Health products are used every day by over 150 million people worldwide.