Pharmacovigilance & Regulatory Affairs Specialist

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

Job summary

BD in Wroclaw, Poland, seeks a Vigilance Specialist to assess and confirm adverse event reportability, draft MIRs, and manage regulatory communications. You will ensure data accuracy in TrackWise and respond to authority inquiries within timelines, contributing to continuous improvement of vigilance processes.

Preferred candidates hold a Life Sciences or related degree, experience in pharmacovigilance or medical devices, and strong English communication skills.

Qualifications

• 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.

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 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.

Skills

English communication

Regulatory knowledge

Vigilance experience

Adaptability

Education

Degree in Life Sciences or related field

Tools

TrackWise

Job description

BD in Wroclaw, Poland, seeks a Vigilance Specialist to assess and confirm adverse event reportability, draft MIRs, and manage regulatory communications. You will ensure data accuracy in TrackWise and respond to authority inquiries within timelines, contributing to continuous improvement of vigilance processes.

Preferred candidates hold a Life Sciences or related degree, experience in pharmacovigilance or medical devices, and strong English communication skills.