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Job Requirements of Senior Manager, Global Pharmacovigilance (PV) Quality Assurance:
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Employment Type:
Contractor
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Location:
Cambridge, MA (Onsite)
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Senior Manager, Global Pharmacovigilance (PV) Quality Assurance
Careers Integrated Resources Inc
Cambridge, MA (Onsite)
Contractor
Job Title: Senior Manager, Global Pharmacovigilance (PV) Quality Assurance
Job Location: Cambridge, MA
Job Duration: 5-6 Months (possibility of extension)
Payrate: $103.12/hr - $110.00/hr on w2
Hybrid: 2x per week, Cambridge
Job Summary:
Job Location: Cambridge, MA
Job Duration: 5-6 Months (possibility of extension)
Payrate: $103.12/hr - $110.00/hr on w2
Hybrid: 2x per week, Cambridge
Job Summary:
- This role is a member of the GVP QA team providing Quality oversight of 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 the companies Inspection activities.
- This position reports to the Director, Global PV Quality Assurance and frequently interacts with cross-functional teams.
- 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.
- 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.
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