PMQ Vigilance Specialist
BD
Wroclaw, PolandPosted about 1 month agoDiscoveredMatch locked
Advertising and Marketing
We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
Key Responsibilities
- Assess and confirm adverse event reportability using approved Decision Trees (DTs).
- Approve or reject non-reportable Decision Trees with documented rationale.
- Draft, review, and complete Manufacturer Incident Reports (MIRs) including Initial, Follow-up, Final reports.
- Complete peer-reviews and approval of MIRs prior to regulatory submission.
- Submit vigilance reports to EMEA Competent Authorities and Notified Bodies and upload objective evidence of submission.
- Manage vigilance activities in TrackWise GCS, ensuring data accuracy, completeness, and traceability.
- Manage and respond to Competent Authority queries within defined timelines.
- Request, assess, and document additional information and re-evaluate reportability where required.
- Support audits, inspections, and continuous improvement of vigilance processes.
Required Qualifications & Experience
- Degree in Life Sciences, Engineering, Nursing, Pharmacy, Regulatory Affairs or related discipline, OR equivalent experience
- Experience in pharmacovigilance or medical device/IVD vigilance, adverse event reporting, or post-market surveillance or regulatory affairs (desirable)
- Demonstrated knowledge of European regulatory and legal requirements in the field of Medical Devices and In Vitro Diagnostic Medical Devices and any specific local requirements.
- Experience using TrackWise (desirable)
- Strong written and verbal (English) communication skills
- Demonstrated ability to adapt to the changing needs of the organisation; including taking on broader aspects of a task and leveraging skills and knowledge to achieve better outcomes for the organization.
- Able to manage multiple activities at the same time and meet internal and external deadlines
- Ability to deal with sensitive information in an appropriate and confidential manner.
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Why join us?
BD is proud to be certified as a Top Employer 2025 in Poland
, reflecting our commitment to creating an exceptional working environment.
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
Become a maker of possible
with us!
Click on apply if this sounds like you!
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
To learn more about BD visit: https://bd.com/careers
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit
https://bd.com/careers .
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
Optional Skills
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Primary Work Location
POL Wroclaw - Legnicka
Additional Locations
Work Shift
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under " Our Commitment to You ."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information
zł99,000.00 - zł150,975.00 PLN Annual
Not included in the source posting: what you'll do, benefits.
Who can apply
The employer didn't state any visa, work authorization, citizenship or clearance requirements in this posting. Confirm with the employer before applying.
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