Medical Devices Adverse Events ReviewerExperience Level: Mid Level | Posted Date: 2025-04-15
Aquí es donde salvas y sostienes vidas
En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.
Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.
Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.
Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.
Summary
Conduct safety reviews for patient harm complaints involving Baxter medical devices, applying medical interpretation and consistency to adverse event (AE) case assessments. Collaborate with clinical counterparts and maintain expertise on assigned medical devices, communicating effectively within and across teams to support medical device safety signaling. Evaluate medical device safety issues and adverse events for licensed products, and perform data entry and quality control peer review of clinical trial data.
What will you be doing?
Providing medical review of individual medical device complaints resulting in patient, user or third party harm.
Ensuring that appropriate medical interpretation, adequate product and therapeutic area knowledge and consistency are applied to device related adverse event case assessments.
Assessing the need for additional safety investigation (clinical follow up) and leading the clinical investigation.
Supporting the MDV safety signaling process by ongoing monitoring of complaints.
Ensuring fast communication of all medical device safety related issues to appropriate collaborators.
Maintaining knowledge of medical device reporting regulations worldwide (especially FDA’s CDRH and European Commission MDD), risk management standards, and quality management systems.
Qualifications and experience crucial for the role:
Healthcare professional, preferably with a Bachelor’s degree in nursing, paramedic, or pharmacy technician.
At least 5 years of medical professional experience (hospital, patient care, or equivalent experience), including 2 years related clinical, safety, pharmacovigilance or regulatory experience in the medical device industry.
Proficient English.
Good analytical and problem solving skills.
Excellent oral and written communication and interpersonal skills.
Nice to have qualifications and experience:
Knowledge of medical device adverse event processing including triage, investigation, medical assessment and submission to regulatory authorities.
Knowledge and understanding of medical device regulations and regulatory guidelines and/or guidance.
Awareness, and preferably working knowledge, of coding dictionaries (e.g. MedDRA).
Experience with commercial databases and ability to work in an enterprise cloud based collaboration environment (box.com).
Knowledge of at least two therapeutic areas (Medication Delivery, Nutrition, Surgery, Anesthesia Critical Care).
Experience with multicultural teams.
Knowledge and understanding of national and international medical device regulations and regulatory guidelines.
Working relationships with and exposure to various Regulatory Authorities worldwide.
Knowledge of medical aspects of medical device safety, medical device vigilance in pre- and post-marketing safety practices.
We offer:
Fixed-term contract for 3 months and then for an indefinite period.
Competitive salary, annual bonuses, recognition award program.
Culture based on our values: collaboration, speed, courage and simplicity.
Possibilities for development on a personal and professional level in one of the leading global MedTech companies.
Package of benefits including Private medical care (Lux Med), Life Insurance, Multisport card.
Bax4U - cafeteria/lunch cards (300 PLN).
PPE program with very attractive conditions available for each employee after 3 months.
Educational support: fully covered language courses (English or other languages according to business needs), financial certifications (ACCA, CIMA).
Co-financing of holidays and an additional 2 days off from work annually.
Day off for birthday!
Employee Stock Purchase Plan.
Bax Flex - hybrid model.
Phenomenal Warsaw office location - Powiśle!
Adaptaciones razonables
Baxter está comprometida para trabajar y proveer ajustes razonables para personas con discapacidades, a nivel global. Si por una condición médica o discapacidad, necesitas algún ajuste en cualquier etapa del proceso de aplicación o entrevista, por favor ingresa a este enlace y déjanos saber la naturaleza de tu requerimiento junto a tu información de contacto.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.