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Sr. Manager, Pharmacovigilance Quality and Compliance - United States  

Company managed [?] Still accepting applications
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Posted on : 24 June 2017

Project Description

  • The Sr. Manager, Pharmacovigilance Quality and Compliance is responsible for developing, performing, and enhancing, compliance and quality systems and strategies for the Pharmacovigilance Department. 
  •  Included in these activities are monitoring safety reporting, procedural and compliance performance metrics, vendor auditing, and pharmacovigilance training. 
  • The Manager will perform compliance and quality assurance activities related to pre- and post-marketing domestic and foreign country regulations and guidelines.  

  • Manages and supports the data quality review process; performs retrospective quality review, generates quality metrics and independently identifies and/or supports in identifying trends. Works within the department and with vendors to improve and maintain data quality, and provides recommendations to the PV team on improvement measures based on quality review results.  
  • Monitors and maintains oversight of all Pharmacovigilance regulatory submissions in conjunction with the regulatory team. 
  • Performs reviews and determines regulatory submission compliance. Works with the submissions manager or designee to ensure timelines and quality of regulatory reporting. 
  •  Assesses training needs for the medical safety/pharmacovigilance department and pharmacovigilance vendors. Participates in the development of training materials and coordination of trainings. Additionally, ensures and maintains relevant pharmacovigilance training of company employees, affiliates, contractors,
  •  Provides oversight to the quality management system for the pharmacovigilance function
  • Actively manages and updates the Pharmacovigilance Department SOPs and internal department guidelines Administers, collects, and regularly reports key performance indicators (KPIs) related to pharmacovigilance processes
  • Maintains ongoing knowledge on Global regulations
  • Supports the Inspection readiness activities for the PV function 
  •  Maintain and execute the training and compliance program for the medical safety/pharmacovigilance department
  • Ensure and maintain pharmacovigilance training of company employees, affiliates, contractors, etc.
  •  Participates in data validation of the safety database and data-entry standards
  •  Provide pharmacovigilance representation during QA/PV team meetings and other cross-functional initiatives related to quality, standards, and training
  • Liaises with Quality Assurance in ongoing evaluations of product complaint trending activities for potential patient safety concerns,, and functions as liaison between QA and PV operations representatives .
  •  In collaboration with the Pharmacovigilance functional heads, supportaudit and regulatory inspection activities of pharmacovigilance systems
  • Liaise with the QA department in the following activities:
  • Supports development of audit plans and assists QA with departmental and vendor audit functions 
  • Assists QA with development of risk-based audit planning focusing on patient and consumer safety 
  • Assists QA with management of departmental quality event (QE) reports and corrective action and preventative action (CAPA) plans
  • Manage and maintain safety reporting agreements with company  partners and collaborators 
  • Provide quality review of safety case files 
  • Supports and contributes to pharmacovigilance system master file activities, as assigned
  •  Other duties as assigned

  •  A bachelor’s degree in a healthcare or scientific discipline, or a combination of formal education and pharmacovigilance related experience
  •  A minimum of 8 years of experience working in biotech/pharmaceutical industry
  • Recent experience in drug-safety reporting and auditing at pharmaceutical sponsor-applicant company
  •  Knowledge of postmarketing FDA regulations and post-authorization ICH/EMA/CHMP regulations and guidelines, and other international regulatory requirements
  • Knowledge of MedDRA dictionary relevant to AE/SAE coding 
  • Experience with software-based drug safety systems (ARGUS)
  • Experience with overseeing and managing vendors
  • Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment
  • Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously
  • Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
  •  Highly proficient in standard computer software (Word, Excel and Power Point)
  • Some travel (approximately 30%/year), in some cases internationally, may be required