Job Description Summary

The Vigilance Specialist is responsible for the end-to-end management of EMEA adverse event vigilance activities in accordance with applicable regulatory requirements and internal procedures. The role ensures timely, accurate, and compliant assessment, reporting, submission, and follow-up of adverse events for BD products managed in the TrackWise Global Complaints System (GCS).

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

Required Skills

Optional Skills

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Primary Work Location

POL Wroclaw - Legnicka

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. 

The salary or hourly rate offered to a successful candidate is determined by their experience, education, and skills, as well as the labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location.

Salary Range Information

zł91,500.00 - zł139,575.00 PLN Annual