Pharmacovigilance Specialist, QPPV Office

Insuvia is an outsourcing and consultancy services provider for the pharmaceutical industry. We help pharmaceutical & biotech companies make safe and effective healthcare products available worldwide by providing superior quality pharmacovigilance and regulatory affairs services. As a Pharmacovigilance Specialist, QPPV Office, you will be responsible for the timely and accurate processing of safety cases in global safety databases, as well as contributing to the implementation and performance of Insuvia’s day-to-day pharmacovigilance and/or clinical safety activities assigned to the QPPV Office and Global PV personnel within the region, ensuring compliance with applicable regulations, policies, and procedures. This role requires a understanding of the pharmacovigilance and/or clinical safety regulatory environment within the European Economic Area (EEA), strong attention to detail, and the ability to work effectively with internal and external stakeholders in a dynamic international setting. Key accountabilities and duties
• Continuously develop professional and personal skills by participating in and timely completing assigned procedural and other training
• Assess received Reportable Events and perform triage and case management activities, including: data entry into the safety database, MedDRA coding, assessment of seriousness, expectedness, and causality, preparation of case narratives, coordination and incorporation of medical review.
• Create and maintain Reportable Event tracker(s) and ensure reconciliation activities
• Monitor assigned safety mailbox, order in mailbox and manage the requests
• Ensure timely and effective communication with internal and external stakeholders.
• Contribute to the preparation of aggregate safety reports.
• Support QPPV Office activities, both general and project-specific, in accordance with competencies and experience.
• Perform other pharmacovigilance-related duties as assigned. Experience, required skills and competencies
• Proven experience in pharmacovigilance
• Life sciences degree (e.g., Pharmacy, Medicine, Biology, Chemistry, Public Health, or a related field) or final-year student in a relevant discipline.
• Excellent organizational, communication, and problem-solving skills.
• Ability to work independently and effectively collaborate with multiple international stakeholders.
• Strong ability to prioritize tasks and manage competing deadlines.
• Fluency in English, both written and verbal.

What we offer
• Engaging, dynamic and diverse work in a young and rapidly growing company;
• International and multicultural environment;
• Additional Vacation Days: After each year, employees are granted additional days off as a representation of appreciation for their dedication and loyalty to the company.
• Health and Wellness

Benefits:
Your well-being matters to us.

We offer
comprehensive health and wellness benefits to ensure your wellness.
• Free Parking: Employees also enjoy the perk of free parking in the city center, complementing the office's central location.
• To promote sustainable commuting, employees who do not require a parking space receive a mobility bonus that can be used towards public transportation costs.
• Company Events and Team-Building Activities: We believe that building strong relationships is essential for a successful team. You'll have the chance to participate in various team-building activities and company events.
• Meaningful Work and Impact: Join a company where your contributions truly matter. You'll be part of projects that make a difference and positively impact our customers and the community.
• Bonus based on annual performance

Salary:
• €1800
- 2500 gross per month. Final salary will depend on your competence and experience.