Medicinal Product Safety Scientist

Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients.

Key Responsibilities

The Safety Scientist is a pivotal role for the benefit-risk evaluation of Idorsia products by

• leading signal management activities,
• planning and writing periodic safety reports writing (DSUR, PBRER),
• supporting the Drug Safety Physician in the safety data analysis and review of the product safety profile and
• providing expertise on global safety regulations and guidelines,

Safety Signal Tracking and Management:

• Acts as the Secretary of Idorsia Drug Safety Committee (DSC) evaluating the safety profile of Idorsia compounds (investigational and marketed)
• Supports Drug Safety Physician in the medical safety evaluation of identified safety signals and preparation of responses to safety queries requested by HAs.
• Acts as the safety signal tracking and management lead ensuring that new safety signals identified are properly tracked and documented ensuring oversight on the signal activities and timely completion of safety measures or actions as determined.
• Monitors PRAC meeting documents or any other relevant sources and informs the responsible Drug Safety Physician and the Head of GDS of any relevant safety information for products of interest for Idorsia (e.g., same class, competitors).

Periodic Safety Reporting and Medical Writing:

• Coordinates the planning schedule and allocation of responsibilities for regulatory aggregated periodic safety reports preparation and submission to HAs.
• Work closely with other departments/functions (e.g., Drug Regulatory Affairs (DRA), Clinical Pharmacology, Clinical Science, Global Medical Affairs) involved in the preparation of aggregated periodic safety reports to ensure that their contribution is accurate and provided in a timely fashion.
• Acts 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.
• Participates in the review of medical/scientific literature relevant for inclusion in periodic safety reports.
• Collaborates with colleagues in DRA to ensure timely regulatory submission of periodic safety reports.
• Support the Drug Safety Physician in the preparation of other types of filing and submission documents to Regulatory bodies e.g., ISS, Reference Safety Information (RSI) section of Investigator Brochure (IB), EU Risk Management Plan (RMP) etc., as required.

Additional responsibilities:

• Performs mentoring of Safety Scientist or related functions, as appropriate.
• Acts as MedDRA expert and participates in the development, update, and maintenance of specifications for data retrieval and analysis.
• Remains current on relevant pharmacovigilance regulations and guidance and ensures that Standard Operating Procedures and Work Instruction related to periodic reports and signal management are up to date and compliant with regulatory requirements.
• Serves as the subject matter lead and expert for improvement initiative, for Health Authorities (HAs) Pharmacovigilance inspections and audits on topics related to signal management and aggregated periodic safety reports.

Candidate Requirements

• University degree in life science (e.g., pharmacy, nursing, M.Sc., or Ph.D.) or equivalent education in health-related field with at least 10 years of experience in pharmacovigilance in the pharmaceutical industry.
• Excellent medical writing skills and previous experience in writing regulatory safety documents (e.g., DSURs, PBRERs/PSURs, and/or Integrated Safety Summary (ISS), clinical study reports etc.).
• Solid knowledge of clinical trial and post-marketing regulatory safety regulations and guidelines (ICH guidelines, European Union [EU], FDA [US]).
• 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.

Work  Location: Allschwil

Country: Switzerland

Business Area: Global Clinical Development, Drug Safety

Schedule: Fulltime

Job Type: Permanent

Job ID: 4531

At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success.
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. All applicants will receive consideration.
We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Idorsia Pharmaceuticals Ltd ("Idorsia") is committed to a fair and transparent application process. In order to avoid any conflict of interest in line with Idorsia Code of Business Conduct, which would undermine such a commitment, the applicants  must disclose any personal, financial, or other outside interests interfering with the interests of Idorsia. Further, the applicant is obliged to disclose any and all relationships with close or affiliated persons, who are employees of Idorsia or are collaborating with Idorsia in any other contractual relationship. 

Please note Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates, or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.