Covance

Senior Pharmacovigilance - Quality Manager

Job Location(s) IN-Pune
Job Number
2021-57827
Job Category
Drug Safety/Pharmacovigilance
Position Type
Full-Time
Telecommute
No

Job Overview

 
Strategic
-        Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
-        Ensure audit readiness and compliance of operations with governing regulatory requirements
-        Create, maintain and assume accountability for a culture of high customer service
-        Nurture and sustain an environment of continuous learning
-        Proactive contribution to process improvements, training and audit readiness at practice level; contribution across all practice-building initiatives

Overall Quality
-        Responsible for instituting and implementing a Qualityprocess across designated PV and Safety writing engagements in scope
-        Drive CAPA management and audit readiness across projects
-        Identify quality trends and suggest corrective actions
-        Implement a feedback process and track implementation of feedback
-        Initiate and support initiatives for standardization of quality processes and process excellence across projects within the practice
-        Function as a Point of Contact for the delivery team for regulatory updates, quality assurance concepts
 
 
Quality Review, Metrics & Analysis
-        Oversee all aspects of quality reviews, metrics, analysis, outcomes, actions across projects within the practice
-        Support internal audits of PV/ Safety writing projects as per the audit calendar and support as required for general systems and process audits
-        Oversee and conduct process reviews to ensure regulatory and client requirements and implement process improvements
-        Work with delivery head & SME to develop, implement Quality Management Plan, provide inputs to Quality Agreements, Training Plans, and monitor Quality SLAs for all designated projects
-        Assume accountability of supporting the client during regulatory inspections and ensuring quality and timely completion of inspection requests.
-        Ensure implementation of Quality Management Plan and / or the Quality Agreement for assigned projects
-        Support Computer System Validation related activities as required.
-        Perform a critical role to ensure organization wide inspection readiness at all times
 
Process, Training and Other
-        Develop general or client-specific PV SOPs and WIs
-        Assess client conventions and provide inputs on their relevance to regulatory requirements
-        Assist delivery teams to identify training needs based on quality review findings
-        Identify process improvements and support delivery teams in the implementation
-        Support practice head in developing process framework, new offerings and customized solutions for clients
-        Assist practice head in ensuring that training material & training plans are reviewed and updated on an ongoing basis, and in conducting training sessions
-        Support business development at practice level by contributing to RFP responses, proposals and client presentations
 

 

Education/Qualifications

- Bachelors/Masters degree in Medicine or Pharmaceutical science
- 10 years of experience in the pharmaceutical industry, primarily in Pharmacovigilance / Safety writing with at least 6 years in Quality, leading quality and process improvements across several Safety projects
- Experience in assessing quality of a case from a medical, scientific and documentation perspective; experience in trending, identification of gaps &training needs
- Clinical Research, Pharmacovigilance, Quality Assurance
- In-depth knowledge of regulatory requirements and ICH-GCP guidelines
- In-depth understanding of single case processing and assessment
- Technical proficiency with Microsoft Office suite of applications
- Understanding of Lean and Six sigma methodologies
- Understanding of system validations

Experience

- 10 years of experience in the pharmaceutical industry, primarily in Pharmacovigilance / Safety writing with at least 6 years in Quality, leading quality and process improvements across several Safety projects
- Experience in assessing quality of a case from a medical, scientific and documentation perspective; experience in trending, identification of gaps &training needs

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