Pharmacovigilance Quality Assurance Manager

Main Responsibilities :

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 client’s 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 client’s 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 client’s 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 client’s 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 documents
• Drive accountability for Quality and Compliance to foster a compliance and Quality driven Culture

Qualifications and Experience :

• Relevant working / residency permit or Swiss / EU-Citizenship required
• 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
• 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

• Reliable, conscientious, goal-oriented
• Excellent at problem solving and ability to measure and manage risk(s)
• Ability to work independently as well as in a team environment
• Excellent communication (verbal and written) and interpersonal skills
• Able 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 advantage
• Proficient in the use of Microsoft Office applications
Vor 30+ Tagen