What We Are Looking For
Idorsia Pharmaceuticals Ltd is seeking a highly skilled and experienced individual to join our team as Global Pharmacovigilance QA Manager. This role will be responsible for ensuring the compliance of Idorsia’s pharmacovigilance activities with international regulations.
Job Responsibilities
* Drive enhanced compliance throughout the PV domain, maintaining and improving a global PV system in accordance with international regulations.
* Lead and manage the planning, conduct and reporting of PV compliance audit programs, ensuring a standardized approach is implemented and maintained across all affiliate sites for PV and the related Quality System.
* Act as primary contact with internal stakeholders (affiliate, corporate functions), establishing and maintaining effective relationships, driving collaboration and providing expert-level PV knowledge and guidance on complex topics and issues.
Key Responsibilities:
1. Perform audits of vendors across affiliate sites as applicable and of affiliates, and maintain oversight of QA consultants appointed to perform PV audits on behalf of the company.
2. Ensure audit results are formally and consistently tracked, recorded, reported, trended.
3. Cooperate with the EU QPPV and national Affiliate Safety Managers (ASM) and take responsibility for interaction with the Competent Authorities, and for the preparation, conduct and follow up of inspections performed at Idorsia sites as applicable.
4. Represent PV QA at local and/or global inspections.
Requirements
* Strong background in Pharmacovigilance/Drug Safety and holds a master's degree in a relevant scientific discipline (Pharmacy or other scientific or health-related fields), additional knowledge in Quality Assurance/Compliance and Auditing.
* Expert knowledge of international Pharmacovigilance regulations (primarily, EU, US, Health Canada regulations & ICH guidelines) of medicinal products for human use.
* In-depth knowledge of pharmaceutical industry practices.
* Experienced in the training of employees on GVP requirements and pharmaceutical industry practices.
Key Skills and Qualifications
* At least 10 years of QA/industry/health authority experience, including the conduct of PV audits (e.g., at corporate HQ / affiliates; distributors; biopharmaceutical partners).
* Prior experience in the coordination of Pharmacovigilance inspections performed by Competent Regulatory Authorities, e.g., FDA, EMA, MHRA, ANSM, BfArM, Health Canada, Swissmedic.
* Excellent problem-solving skills and ability to measure and manage risk(s).
* Ability to work independently as well as in a team environment.
We are committed to fostering a respectful and inclusive workplace culture that encourages collaboration, open communication, and diversity.
Please note that if you are selected for this position, your employment will be subject to a pre-employment background screening process, which will be informed in greater detail in due course.