Pharmacovigilance Specialist — Regulatory Reports

BD; Wrocław; On-site; PLN 99,000 - 151,000; Full time

Benefits offered by this job

Top Employer Poland 2025

Job summary

BD, a leading global medical technology company, seeks a Vigilance Officer in Wroclaw to manage adverse event reporting, MIRs, and regulatory submissions. You will work closely with regulatory teams to ensure timely, accurate vigilance activities.

The role requires a life sciences or related degree, English proficiency, and the ability to handle confidential information while coordinating multiple tasks under deadlines. On-site presence is expected at POL Wroclaw.

Qualifications

• Degree in Life Sciences, Engineering, Nursing, Pharmacy, Regulatory Affairs or related field, or equivalent experience.
• Experience in pharmacovigilance or medical device/vigilance is desirable.
• Strong knowledge of European regulatory requirements for Medical Devices and IVDs.

Responsibilities

• Assess and confirm adverse event reportability using approved Decision Trees.
• Approve or reject non-reportable DTs with documented rationale.
• Draft, review, and complete MIRs including Initial, Follow-up, Final reports.
• Peer-review and approve MIRs prior to regulatory submission.
• Submit vigilance reports to authorities and upload evidence.
• Manage vigilance activities in TrackWise GCS with accuracy.
• Respond to Competent Authority queries within timelines.
• Request and document additional information and re-evaluate reportability.
• Support audits, inspections, and continuous improvement of vigilance processes.

Skills

English communication

Multitasking

Confidentiality

Adaptability

TrackWise (desirable)

Education

Life Sciences or related degree

Tools

TrackWise

Job description

BD, a leading global medical technology company, seeks a Vigilance Officer in Wroclaw to manage adverse event reporting, MIRs, and regulatory submissions. You will work closely with regulatory teams to ensure timely, accurate vigilance activities.

The role requires a life sciences or related degree, English proficiency, and the ability to handle confidential information while coordinating multiple tasks under deadlines. On-site presence is expected at POL Wroclaw.