Manager, Global Pharmacovigilance and Risk Management (Woman / Man)

Manager, Global Pharmacovigilance and Risk Management (Woman / Man)

Miejsce pracy: Gorzów Wielkopolski

Your responsibilities

• Independently 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.
• Provide medical expertise during CCSI/CCDS, RMPs/REMS, aggregate reports and DSURs creation.
• Prepare Health Hazard evaluations (HHE's) and create respective documents in close cooperation with involved departments.
• Prepare responses to ad-hoc requests from regulatory agencies.
• Maintain pharmacovigilance expertise, understanding international safety regulations and guidelines.
• Understating emerging AI tools is advantageous.
• Develops, communicates, and implement best practices, SOPs, templates, work instructions, etc. as called for or specified in assigned tasks and projects.
• Work collaboratively with internal stakeholders, including members of Medical Affairs, Clinical Trials, and Regulatory Affairs, in a matrix environment as needed for specific project needs/plans.

Our requirements

• Education/qualifications: Medical degree (MD or equivalent primary medical qualification, such as MBBS or bachelor’s in human medicine)or Veterinary degree.
• Have relevant pharmacovigilance experience (minimum 5 years) primary in signal detection.
• In-depth knowledge of signal detection and risk management principles.
• Thorough understanding of international pharmacovigilance regulations including EU, ICH, FDA guidelines and regulations.
• Knowledge of statistical software and use of drug safety database.
• 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

• Work in a global role within an international setting
• Collaborate in a positive and supportive team environment
• Opportunity for continuous learning and professional growth within a team of experienced professionals

Benefits

• sharing the costs of sports activities
• private medical care
• sharing the costs of foreign language classes
• life insurance
• flexible working time
• mobile phone available for private use
• retirement pension plan
• preferential loans
• corporate credit card
• extra social benefits
• sharing the costs of tickets to the movies, theater
• holiday funds
• employee referral program

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.

We are an Equal Opportunity Employer. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

Bausch Health Poland Sp z.o.o.

Bausch Health Poland jest częścią międzynarodowego koncernu farmaceutycznego Bausch Health Companies Inc., który rozwija, wytwarza oraz dostarcza szeroką gamę najwyższej jakości leków Rx, OTC, suplementów diety, wyrobów medycznych oraz sprzętu medycznego. Realizujemy nasze zobowiązania, budując innowacyjną firmę zajmującą się poprawą zdrowia na świecie. Każdego dnia z naszych produktów korzysta ponad 150 milionów ludzi na całym świecie.

21 000 naszych pracowników łączy misja poprawy ludzkiego życia poprzez zaangażowanie w projekty związane z edukacją, profilaktyką zdrowotną i promocją aktywnego stylu życia.

„Wyrażam zgodę na przetwarzanie moich danych osobowych w celu rekrutacji zgodnie z art. 6 ust. 1 lit. a Rozporządzenia Parlamentu Europejskiego i Rady (UE) 2016/679 z dnia 27 kwietnia 2016 r. w sprawie ochrony osób fizycznych w związku z przetwarzaniem danych osobowych i w sprawie swobodnego przepływu takich danych oraz uchylenia dyrektywy 95/46/WE (ogólne rozporządzenie o ochronie danych) jak również zgodnie z Ustawą Dz.U.2018.1000 O ochronie danych osobowych”.