Senior Manager Global Pharmacovigilance (PV) Quality Assurance
Job Title: Senior Manager Global Pharmacovigilance (PV) Quality Assurance Location: reputed company for Remote/Hybrid /Cambridge MA Duration: 8 months+ (Possible Extension) Pay reputed company -$80 - $90/hr. on w2 Responsibilities: This role is a member of the GVP QA team providing Quality reputed company of client 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 client 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 reputed company the GVP QA's responsibilities as listed below. Different members of the team will have particular focus areas. Senior Manager will reputed company 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 reputed company to management.
- Support the Global Strategic Audit Program - contribute to risk-based audit strategy and maintain and enhance PV audit reputed company, risk tools and reputed company PV audit schedule.
- reputed company QA Audit, CAPA and Supplier data for the PV System Master File (PSMF). reputed company and maintain efficient processes to ensure comprehensive and accurate data.
- reputed company and maintain processes and tools to support quality audit execution and reputed company.
- Support PV / post-marketing surveillance inspection readiness and inspection management activities.
- reputed company Quality reputed company of PV, PMS and PV-reputed company vendors. This includes vendor notification, qualification assessments, Quality Agreements, KQIs and audits.
- reputed company and report GVP QA metrics and dashboards to support quality reputed company.
- reputed company and maintain GVP QA Training Plan; conduct PV and PMS training sessions for QA and EAs.
- reputed company 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 guidance and ICH.
- Experience supporting Health Agency inspections.
- Self-motivated with the ability to demonstrate initiative and internal drive for reputed company 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 reputed company situations / issues. Demonstrates
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