Idorsia is looking for a Drug Safety Scientist to support the benefit–risk evaluation of our products and contribute to patient safety throughout the product lifecycle. You will join a dynamic and international organization focused on harnessing the power of difference, authenticity, and inclusion.
What You'll Do
- Support the Drug Safety Physician in the medical safety evaluation of identified safety signals and preparation of responses to safety queries from Health Authorities.
- Act as the safety signal tracking and management lead, ensuring proper tracking, documentation, and oversight of signal activities.
- Monitor PRAC meeting documents or other relevant sources for safety information on products of interest for Idorsia.
- Coordinate the planning schedule and allocation of responsibilities for regulatory aggregated periodic safety reports preparation and submission.
- Work closely with other departments involved in the preparation of aggregated periodic safety reports to ensure accurate and timely contribution.
- Act as the lead author in close cooperation with the responsible Drug Safety Physician in the medical writing of periodic safety reports or other ad-hoc safety analysis reports.
- Participate in the review of medical and scientific literature relevant for inclusion in periodic safety reports.
- Collaborate with colleagues in Drug Regulatory Affairs to ensure timely regulatory submission of periodic safety reports.
- Support the Drug Safety Physician in the preparation of other filing and submission documents to Regulatory bodies.
- Perform mentoring of Safety Scientist or related functions, as appropriate.
- Act as a MedDRA expert and participate in the development, update, and maintenance of specifications for data retrieval and analysis.
- Remain current on relevant pharmacovigilance regulations and guidance and ensure Standard Operating Procedures and Work Instructions are up to date.
- Serve as the subject matter lead and expert for improvement initiatives, for Health Authorities Pharmacovigilance inspections and audits on topics related to signal management and aggregated periodic safety reports.
What We're Looking For
- A university degree in life science or equivalent education in a health-related field.
- At least 10 years of experience in pharmacovigilance in the pharmaceutical industry.
- Excellent medical writing skills.
- At least 3 years of experience in writing regulatory safety documents.
- Solid knowledge of clinical trial and post-marketing regulatory safety regulations and guidelines.
- Excellent communication, interpersonal and problem-solving skills.
- Strong organizational skills and ability to work within tight timelines with effective project management skills.
- Effective communication in English, both verbally and in writing.
- Excellent knowledge of MedDRA coding thesauri and SMQs and WHO drug dictionary and SDGs.
- Strong analytical skills with attention to details.
Team & Environment
You will report to the Drug Safety Physician / Head of Global Drug Safety and work in a collaborative, solution-oriented environment.
Benefits & Compensation
- Opportunities to grow, learn, and expand your expertise in a dynamic and international organization.
- A supportive, solution-oriented environment where teamwork, initiative, and new ideas are encouraged.
- International exposure, working in a truly multicultural setting with colleagues and partners from around the world.
Work Mode
This is an onsite position located in Allschwil.
We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees.
