Full Description

Responsibilities

This role is a member of the GVP QA team providing Quality oversight of Alnylam’s global post-marketing pharmacovigilance system, including clinical safety, full application of EMA Good Pharmacovigilance Practices (GVP) Modules, and implementation of other worldwide PV regulations. This includes support for the development and execution of the GVP audit program as well as contributing to Alnylam’s Inspection activities. This position reports to the Director, Global PV Quality Assurance and frequently interacts with cross-functional teams.

Summary of Key Responsibilities

Senior Manager, PV QA supports all the GVP QA’s responsibilities as listed below. Different members of the team will have particular focus areas. Senior Manager will lead specific activities

• Serve as a strong partner with Expertise Areas (EAs) in the enhancement of the global pharmacovigilance system, including ensuring compliance with GVP regulations. This includes review of procedural documents.
• Partner and support EAs in ensuring conduct of non-interventional, observational, and post-marketing surveillance (PMS) meet regulatory requirements and expectations considering Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP)
• Support cross GxP QA activities requiring PV and PMS expertise.
• Execute on global core auditing processes for licensing partners, external vendors, internal audits, affiliates, and other applicable service providers in a post-marketing environment.
• Determine, evaluate and investigate Quality Events. Determine adequacy of root cause analyses and CAPAs. Applies risk-based thinking in determining required actions.
• Effectively communicate and escalate critical matters to management.
• Support the Global Strategic Audit Program - contribute to risk-based audit strategy and maintain and enhance PV audit universe, risk tools and develop PV audit schedule.
• Provide QA Audit, CAPA and Supplier data for the PV System Master File (PSMF). Develop and maintain efficient processes to ensure comprehensive and accurate data.
• Develop and maintain processes and tools to support quality audit execution and outcomes.
• Support PV / post-marketing surveillance inspection readiness and inspection management activities.
• Provide Quality oversight of PV, PMS and PV-related vendors. This includes vendor notification, qualification assessments, Quality Agreements, KQIs and audits.
• Develop and report GVP QA metrics and dashboards to support quality oversight.
• Develop and maintain GVP QA Training Plan; conduct PV and PMS training sessions for QA and EAs.
• Lead or contribute to Quality or PV and PMS initiatives. Identify and propose process improvement opportunities and solutions.
• Other assignments as directed.
• Requirements and skills
• Educated to university degree (preferably life sciences) or equivalent qualification or experience
• Extensive experience in the pharmaceutical industry in a quality or compliance function.
• Audit skills and experience of conducting GVP audits is preferred.
• Understanding of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidances and ICH.
• Experience supporting Health Agency inspections.
• Self-motivated with the ability to demonstrate initiative and internal drive for continuous improvement.
• Strong interpersonal, verbal, and written communication skills. Builds positive and productive working relationships.
• Diplomatic in addressing sensitive issues confidentially and professionally. Works professionally with confidential information.
• Ability to analyze complex situations / issues. Demonstrates strategic thinking