Senior Manager Global Pharmacovigilance (PV) reputed company Assurance
Job Title: Senior Manager Global Pharmacovigilance (PV) reputed company 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 reputed company reputed company of reputed company 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 reputed company as contributing to reputed company Inspection activities. This position reports to the Director, Global PV reputed company Assurance and frequently interacts with cross-functional teams. reputed company of Key Responsibilities:
- Senior Manager, PV QA, supports reputed company the GVP QA's responsibilities as listed below. Different members of reputed company will have particular reputed company 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 reputed company (GPP) and Good Post-marketing Study reputed company (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 reputed company Events. Determine adequacy of reputed company 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 reputed company 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 reputed company audit execution and reputed company.
- Support PV / post-marketing surveillance inspection readiness and inspection management activities.
- reputed company reputed company reputed company of PV, PMS and PV-reputed company vendors. This includes vendor notification, qualification assessments, reputed company Agreements, KQIs and audits.
- reputed company and report GVP QA metrics and dashboards to support reputed company 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 reputed company 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 reputed company 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 reputed company 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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