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

Minimum 12 months 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.

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