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Manager, Pharmacovigilance QA and Deviations Management

Cambridge, Massachusetts, Bridgewater, New Jersey

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Overview

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Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

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    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."

Shannon Resetich US Head Rare Diseases & Blood Disorders

"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."

Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

Under the supervision of the QA and Deviation Management Head, the incumbent participates in activities ensuring the suitability of the GPV quality system by performing a quality assessment on the content of data/output and key Pharmacovigilance activities (global and local). Additionally, the incumbent supports Medical Quality activities as specified below. 

  • Participate in GPV Quality continuous improvement and Operational excellence programs: Assist with Quality Risk Profiles and remediation plans. 

  • Perform quality assessment of PV activities pre-identified in the GPV quality management system, in measuring compliance to process, process effectiveness, and data quality: 

  • Participates in activities ensuring the suitability of the GPV quality system by performing a routine quality assessment on the content of data/output, data integrity, and key Pharmacovigilance activities. 

  • Interact with any GPV units involved in the concerned reviewed activity and generate data/outputs to discuss findings. 

  • For Global PV and medical quality events and alerts, Lead Investigation of issues, identify the root cause and propose Corrective Action Plan Activities (CAPA); participate in CAPA implementation, ensure monitoring activities to measure effectiveness. 

  • Detect processes at risk requiring further quality assessments in the Pharmacovigilance network. 

  • Interact with auditors, inspectors as well as GPV and Medical groups to provide input and participate in audit and inspection activities at both global and local levels.   

  • For local deviations, provide guidance to CSH for appropriate quality event tracking and quality event risk assessment. 

  • For local deviations, collaborate as required with CQH/RQH on quality alerts and appropriate implementation of risk actions plan. 

  • Perform Quality qualification of vendors for both GPV and Medical GxP outsource initiatives. 

POTENTIAL SPECIFIC DOMAINS  

  • Strong analytical skill and developed insight for analysis of issues ensuring scientific rigor/good quality in all analyses and decision-making based on sound risk-based judgment 

  • Excellent writing and communication skills. 

  • Strong interpersonal skills: interaction with individuals of various backgrounds such as various levels in other departments and other countries  

  • Ability to provide a clear concise summary and identify key issues which are a concern for GPV or Medical. 

  • Ability to work independently and successfully manage multiple priorities simultaneously. 

  • Ability to identify a gap in quality issue and investigate to clarify root cause. 

  • Demonstrated ability to participate in the creation of a corrective action plan and monitor its effectiveness to meet the needs of associates/department/unit/country/GPV/Medical. 

  • Computer literacy (Microsoft Office).  

  • Good understanding of Quality Management systems and their implementation 

  • In-depth knowledge of International Pharmacovigilance requirements, e.g., US FDA, EMEA requirements/international guidelines, ICH/CIOMS. 

SPECIFIC WORKING EXPERIENCE:    

  • Bachelor's degree required. Health Science degree required; Certified health professional degree preferred: example Pharmacist or Pharm D or Bachelor of nursing degree.  

  • Minimum experience 5 years in International Pharmacovigilance activities including case processing, involvement in interaction with affiliates, training users  

  • Health Science degree required; Certified health professional degree preferred: example Pharmacist or Pharm D or Bachelor of nursing degree.  

  • Demonstrated Understanding of Pharmacovigilance processes, PV database system, Dictionaries required. 

  • Quality management strongly preferred: QA, audit, corrective action plan (CAPA methodology) definition, and implementation 

  • Knowledge of international regulations and guidelines, e.g., ICH, CIOMS, EMEA/FDA 

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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