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Assistant Director Medical Device Safety, Pharmacovigilance

  • Bayer
  • $118,075.00 - 199,650.00 / Year *
  • Whippany, NJ 07981
  • Full-Time



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We pride ourselves in being research-driven, with businesses in CropScience and HealthCare. We are also proud of our environmental record, our safety performance, and our manufacturing expertise. You can only imagine our pride at being named one of Fortune magazine's most admired companies.



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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life.






At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.



Apply online





Assistant Director Medical Device Safety, Pharmacovigilance



Your tasks and responsibilities



The primary responsibilities of this role, Assistant
Director Medical Device Safety, Pharmacovigilance , are
to:









+ Provide content input to Project teams
for designing, planning and conducting analyses of safety data for
the assessment of medical device safety and
performance;



+ Provide content input to the
post-marketing surveillance (PMS) program activities including, PMS
system documentation, PMS planning and report management, PMS
trending methodologies, analysis and written
contributions;



+ Provides New Product Development
contributions to design control for medical devices throughout the
AS process;



+ Develop global trending methodologies
for integration into PMS program
activities;



+ Make
recommendations based on integrated trending analyses and generate
presentations in collaboration with program
teams;



+ Support standardization of database
structures and implement standard processes required for integrated
trending activities;



+ Responsible for the production and
accuracy of medical device analysis and interpretation of
results;



+ Responsible for the orchestration of
PMS program activities under the ownership of
PVMDS.













Who you are







Your success will be driven by your demonstration of
our LIFE values. More specifically related to this position,
Bayer seeks an incumbent who possesses the
following:







Required Qualifications:









+ Bachelor's Degree in Engineering, Mathematics
or Life-science Discipline with 4 years of professional experience
in medical devices or similar sector;



+ Working understanding of medical device
regulations and industry standards globally specifically 21 CFR
820, 803, ISO 13485, and euMDR 2017/745;



+ Good scientific application of
statistical methods used for evaluating complaint trends and
establishing thresholds for routine trend reviews (e.g. human
factor, malfunction, user interface and user
safety);



+ Able to develop and administer
management information systems for track and
trending;



+ Strong analytical and technical skills
that include data collection, analysis and required report
generation;



+ Strong communication skills and ability
to work both, independently and cross-functionally with Quality,
Regulatory, Marketing and other applicable functions within the
business;



+ Demonstrated ability to think outside
the box and make recommendations for
improvement;



+ Good presentation and writing skills
(summary reports, evaluations,
etc.)



+ Fluent in
English.









Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the \"Passion to Innovate\" and the \"Power to Change\", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.













Bayer is an Equal Opportunity Employer/Disabled/Veterans







Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

















Country:United States

Location:NJ-Whippany

Functional Area:[sap_fa_30]

Entry Level:5
Associated topics: climate, emr, environmental, hospital, physician, safe, treatment, usda, wastewater, water


* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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