Global Senior Pharmacovigilance QA Manager

About Idorsia Pharmaceuticals LtdHeadquartered 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.We are looking for a Global Pharmacovigilance QA Manager to join our team Job ResponsibilitiesThe Global Pharmacovigilance QA is a strategic role that drives enhanced compliance throughout the PV domain to support the obligation of the Marketing Authorization Holders and appointed QPPV, to maintain and improve a Global PV system in accordance with international regulations. He/She independently leads and manages the planning, conduct and reporting of PV compliance audit programs and ensures a standardized approach is implemented and maintained across all affiliate sites for PV and the related Quality System.Experience in Commercial GDP QA /Supply Chain QA is an advantage.Act as a 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. Take an active role in, and lead key project initiatives across the organisation, and independently provide strategic advice to internal or external stakeholders to drive policy and decision making.Act as local PV QA Manager appointed to affiliate sites and ensure implementation of a standardized PV system, consistent with HQ procedures. Support Idorsia affiliate sites as applicable in the establishment, implementation and management of their local PV system.Maintain, improve and assure execution of a risk-based, global PV QA audit program covering internal and external audits to verify adherence to the PV system, as defined in FDA and EMA Regulations.Perform PV QA 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.Ensure audit results are formally and consistently tracked, recorded, reported, trended.Ensure corrective/preventive actions have been identified, documented and are effective.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. Represent PV QA at local and/or global inspections.Responsible for escalation of significant PV compliance issues to senior management.Provide in a timely manner the necessary QA output to the EU QPPV (and national ASMs, if applicable) to establish and maintain the PSMF Quality section and audit related PSMF annexes.Ensure inspection readiness of vendors conducting PV activities through metric review, vendor audit findings, CAPA generation and review, and training.Ensure procedures for archiving of records at affiliate sites are in line with Idorsia policies.Review the suitability of procedures for CAPA and deviation management, root cause analysis and perform QA effectiveness checks at HQ and at affiliate sites.Ensure appropriate and timely management of non-conformances related to relevant GxP: deviations, change controls, internal and external CAPAs, Quality Events.Manage Affiliate documentation and training records within Idorsia Quality System, in collaboration with HQ QA and affiliate. Review and approve local (GxP related) standard documentation and develop local Quality related procedures as required, in accordance with HQ QA principles and processes. Monitor training compliance.Plan and execute periodic exchange of information across affiliate sites regarding PV system topics.Maintain high level of knowledge of current global pharmacovigilance regulations, updates to regulations and good pharmacovigilance practices.Evaluate changes and proposed changes to country specific laws and regulations related to PV as applicable. Keeping Affiliate Management and HQ QA informed about significant changes and maintaining an updated record of applicable country specific laws, regulations, requirements and regulatory procedures. Support the ASM to conduct impact assessments for new or updated PV regulations.Maintain oversight and review the content of key global and local Quality System documentsDrive accountability for Quality and Compliance to foster a compliance and Quality driven CultureCandidate's RequirementsStrong 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 useIn-depth knowledge of pharmaceutical industry practicesExperienced in the training of employees on GVP requirements and pharmaceutical industry practicesAt 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, SwissmedicReliable, conscientious, goal-orientedExcellent at problem solving and ability to measure and manage risk(s)Ability to work independently as well as in a team environmentExcellent communication (verbal and written) and interpersonal skillsAble to establish collaborative partnerships with internal and external stakeholders and colleagues globally, and apply diplomatic skills in resolving difficult situations.Languages: fluent in English - knowledge of German and French would be advantageous Experience in GDP, warehousing and distribution of commercial products and commercial affiliate QA aspects to also act as Affiliate QA Manager/Supply Chain QA manager is an advantageProficient in the use of Microsoft Office applicationsWork Location: Basel AreaCountry: SwitzerlandBusiness Area: Quality AssuranceSchedule: FulltimeJob Type: PermanentAt 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.