Sr. QPPV Office (QPO) Specialist

Biomapas; Poland; Hybrid; PLN 40,000 - 60,000; Full time

Job summary

A global Pharmacovigilance company is seeking a Sr. QPPV Office Specialist to manage pharmacovigilance systems and ensure compliance with regulations. The ideal candidate will have at least 4 years of experience in pharmacovigilance and a university degree in a related field. This role offers opportunities for professional growth and flexible working hours.

Benefits

Professional growth and career opportunities

International team and environment

Bonus based on annual performance

Personal accident and business trip insurance

Influenza vaccines

Rewarding referral policy

Workplace establishment allowance

Flexible working hours

Team building events

Qualifications

• At least 4 years of experience in pharmacovigilance roles.
• In-depth knowledge of pharmacovigilance legislation is essential.
• Experience in regional QPPV role and risk minimization is desirable.

Responsibilities

• Manage full Pharmacovigilance systems and projects.
• Ensure compliance with Pharmacovigilance tasks.
• Provide Pharmacovigilance trainings.

Skills

Attention to detail

Time-management

Problem-solving skills

Fluent English language

Good knowledge of medical terminology

Education

University degree in Life Science field

Tools

MS Office

Safety databases

Job description

Overview

Join our global Pharmacovigilance team as a Sr. QPPV Office (QPO) Specialist. The Sr. QPPV Office (QPO) Specialist is responsible for the development of pharmacovigilance systems, and the oversight of end-to-end pharmacovigilance activities and projects' compliance with Quality Management System as well as the reporting and exchanging of safety and pharmacovigilance information for medicinal products. Position is in any EU country.

Responsibilities

• Manage full Pharmacovigilance systems and projects (or part of them)
• Promote, maintain, improve compliance with Pharmacovigilance (PV) tasks and responsibilities
• May act as Regional QPPV or deputy
• Influence the performance of the quality system and PV activities
• Develop, update, and review standard operating procedures for global pharmacovigilance processes, and implement changes to fulfill requirements
• Supervise, prepare and submit PSURs, Risk Management Plans and risk minimization activities
• Be the primary point of contact for PV-related matter; Ensure oversight of the contractual partner safety data exchange agreements
• Ensure the survey and monitoring of European (including UK) level pharmacovigilance regulations
• Provide Pharmacovigilance trainings
• Ensure continuous safety profile monitoring, detection of new signals and evaluation
• Communication with Competent Authorities
• Participate in related inspection and/or audits

Requirements

• University degree in Life Science field
• At least 4 years of experience in pharmacovigilance roles, including in-depth, demonstrated experience in most areas pertaining to pharmacovigilance, and expert knowledge of pharmacovigilance legislation
• Experience in regional QPPV role and risk minimization activities will be considered as an asset
• Experience in Pharmacovigilance Medical writing
• Strong computer literacy with intensive experience with safety databases
• Ability to interpret and apply global drug safety regulations
• Fluent English language
• Good knowledge of medical terminology
• Attention to detail, time-management and problem-solving skills
• Proficient knowledge in MS Office

Benefits

• Professional growth and career opportunities
• International team and environment
• Bonus based on annual performance
• Personal accident and business trip insurance
• Influenza vaccines
• Rewarding referral policy
• Workplace establishment allowance
• Flexible working hours
• Team building, global meetings, B active events