Local Drug Safety Officer

Following a new opportunity in partnership with one of the top 10 Pharmaceutical Companies in the World, we are currently looking for a team of Local Drug Safety Officer available to work remotely.

The professional will be responsible for providing routine support in daily pharmacovigilance activities, managing drug adverse events and medical device incidents, and ensuring the quality and compliance of case management.

You will be responsible for

1. Pharmacovigilance Support:
- Perform daily monitoring and management of adverse drug event reports, ensuring timely and accurate documentation and reporting.
- Assess the seriousness, expectedness, and causality of adverse events in accordance with regulatory requirements and company SOPs.
- Collaborate with healthcare professionals and internal teams to ensure proper follow-up on adverse event cases.

2. Medical Device Incident Management:
- Handle the reporting and management of medical device incidents, ensuring compliance with local and EU regulations.
- Conduct thorough investigations of medical device incidents and contribute to root cause analysis and corrective actions.
- Ensure timely submission of incident reports to regulatory authorities and maintain accurate records.

3. Quality Check and Compliance:
- Perform quality checks of individual case safety reports (ICSRs) to ensure accuracy, completeness, and regulatory compliance.
- Review and validate data entries related to adverse events and medical device incidents in safety databases.
- Support internal audits and inspections by regulatory authorities, ensuring readiness and compliance with pharmacovigilance standards.

4. Communication and Collaboration:
- Liaise with internal departments such as Local and Corporate Pharmacovigilance Teams, Quality Assurance, Regulatory Affairs, and Medical Affairs to ensure seamless communication and coordination of safety-related activities.
- Provide training and guidance to local teams on adverse event and incident reporting processes.
- Prepare and deliver safety reports and summaries to management and relevant stakeholders.

About you
• Bachelor’s degree in Pharmacy, Medicine, Life Sciences, or a related field.
• Master in Pharmacovigilance or Regulatory Affairs is appreciated
• Minimum of 2 years of experience in pharmacovigilance or drug safety, with a focus on adverse event and medical device incident management.
• Strong knowledge of German and EU regulations related to pharmacovigilance and medical device safety.
• Experience in quality checking and validating case reports.
• Fluent in German (mandatory) and proficient in English.
• Ability to work independently as well as in a team environment.
• Available to work full-time remote

Preferred Qualifications:
• Experience with safety databases (e.g., Argus, ArisGlobal) and incident management systems.
• Certification in pharmacovigilance or drug safety trainings/corurse is an advantage.

Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.
Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.