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 Drug Safety Compliance Manager works in a team-oriented environment and is responsible for ensuring compliance with global regulatory requirements, development of compliance reports/metrics and implementation of corrective/preventative actions to address any identified non-compliance. He/She supports the Head Drug Safety Operations and Compliance and acts as deputy to the European Union Qualified Person for Pharmacovigilance (EU QPPV) in the governance of all compliance aspects, Idorsia Pharmacovigilance system and PV procedural documents.

Pharmacovigilance Compliance activities:

• Ensure proper configuration of the expediting requirements in the safety database.
• Create periodic Compliance/Quality/KPI report to monitor Global Drug Safety (GDS) Operation activities, reporting and submission to health authorities worldwide
• Manage deviations and CAPA for GDS and conduct trend analysis in collaboration with QA
• Acts as business lead and/or support GDS internal audits and Health Authorities inspection readiness and management activities.
• Manage business change requests for GDS systems.
• Support management of pharmacovigilance agreements with license and business partners.

Clinical Trial Activities:

• Review/approve clinical trials Safety Management Plans (SMPs) with Contract Research Organizations (CROs) in collaboration with Drug Safety Operations.
• Participate in bid defense meetings and review CRO budget proposals for clinical trials.

Quality System (QS) Documents:

• Monitor and manage GDS quality system documents and ensure timely periodic review.
• Ensure that GDS QS documents are up to date, reflect the current procedure or practice and ensure proper implementation.

Acts as Deputy European Union Qualified Person for Pharmacovigilance (Deputy EU QPPV):

• Contact point for the competent authorities in Member States and the European Medicines Agency during absence of the EU QPPV.
• Deputize EU QPPV during absence for tasks and responsibilities related to compliance aspects and Idorsia Pharmacovigilance system.
• Act as Trusted Deputy/Responsible Person for Eudravigilance with regards to EVWEB and XEVMPD.
• Support the preparation, maintenance and quality control of the pharmacovigilance system master file (PSMF) involving cross-functional interactions.

Additional responsibilities:

• Lead/contribute training activities for new/existing GDS employees or other functions/external service providers on all quality and compliance aspects associated with pharmacovigilance.
• Support system upgrade projects including testing and validation activities.
• Support data migration and cleaning activities.

Candidate Requirements

• University degree in life science (Pharmacy, nurse, MSc, PhD) or equivalent education in health-related field.
• At least 7-10-year experience in safety, quality assurance and/or Pharmacovigilance (PV) audit.
• Experience in managing Health Authority PV and GCP inspections.
• Experience in writing procedural documents and developing corrective and preventive action plans (CAPAs)
• In depth understanding of quality assurance and compliance concepts.
• Good knowledge and understanding of ICH guidelines, European regulations, US Code of Federal Regulations, and other relevant pharmacovigilance regulations worldwide.
• Broad knowledge of all aspects of pharmacovigilance activities and risk management.
• Experience in managing departmental projects or process improvement initiatives.
• Experience in safety data management including the collection, processing and reporting of adverse events.
• In depth knowledge of coding thesauri and medical/drug dictionaries.
• Excellent written and verbal communication skills.
• Excellent organizational, problem-solving and interpersonal skills, and the ability to work under pressure and meet short timelines.

Work Location: Allschwil, Basel Area

Country: Switzerland

Business Area: Global Clinical Development, Drug Safety

Schedule: Fulltime

Job Type: Permanent

Job ID: 4530

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.