Pharmacovigilance Officer – English Required

Über das Unternehmen

Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. With a rich history of innovation, we discover and develop breakthrough treatments that improve health and extend lives. Our commitment to scientific excellence and patient-focused care drives us to be a leader in the pharmaceutical industry, operating in over 140 countries and employing more than 100,000 associates globally. Join us in our mission to reimagine medicine.

Stellenbeschreibung

We are seeking a dedicated and detail-oriented Pharmacovigilance Officer to join our team in Graz, Austria. This crucial role is responsible for ensuring the safety monitoring of our pharmaceutical products. The successful candidate will play a key role in collecting, processing, and reporting adverse event information in compliance with global and local regulatory requirements. Strong English language skills are essential for this position, as you will be working with international teams and documentation. If you are passionate about patient safety and have a meticulous approach to data, we encourage you to apply.

Hauptverantwortlichkeiten

• Process and report individual case safety reports (ICSRs) from various sources in a timely and accurate manner.
• Perform quality control checks on adverse event data to ensure compliance with company SOPs and regulatory guidelines.
• Conduct literature searches and review safety data for signals of potential new risks.
• Contribute to the preparation and submission of aggregate safety reports (e.g., PSURs, DSURs).
• Liaise with internal departments (e.g., Clinical Development, Regulatory Affairs) and external partners on pharmacovigilance-related matters.
• Participate in safety data reconciliation activities and ensure database accuracy.
• Maintain up-to-date knowledge of relevant pharmacovigilance regulations and guidelines (e.g., ICH-GCP, GVP).
• Assist in audits and inspections by regulatory authorities.

Erforderliche Fähigkeiten

• Bachelor's degree in Pharmacy, Life Sciences, Nursing, or a related healthcare field.
• Excellent command of the English language, both written and verbal, is mandatory.
• Minimum of 2 years of experience in pharmacovigilance or a related field within the pharmaceutical industry.
• Strong understanding of pharmacovigilance principles and regulatory requirements (GVP, ICH guidelines).
• Proficiency in using safety databases (e.g., Argus, ArisG).
• Meticulous attention to detail and strong organizational skills.
• Ability to work independently and as part of a global team.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).

Bevorzugte Qualifikationen

• Master's degree or Pharm.D.
• Experience with medical coding systems (e.g., MedDRA, WHODRUG).
• Familiarity with Austrian or EU pharmacovigilance regulations.
• Experience in a global pharmacovigilance setting.

Vorteile & Zusatzleistungen

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holiday schedule.
• Opportunities for professional development and career advancement.
• Access to cutting-edge research and innovative projects.
• Employee wellness programs and on-site facilities.
• Pension scheme and employee share purchase program.
• Subsidized public transport ticket.
• Flexible working arrangements where applicable.

Jetzt bewerben