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Director, Pharmacovigilance - United States  

Company managed [?] Still accepting applications

Posted on : 03 August 2017

Project Description

Description:
  • Lead cross-departmental activities in support of clinical and postmarketing pharmacovigilance operations activities
  •  Oversee and manage US and EU clinical and postmarketing pharmacovigilance activities, pharmacovigilance staff, and global pharmacovigilance service provider(s) contracted for supporting clinical and postmarketing pharmacovigilance activities
  •  Support compliance with US, EU and Rest of World safety reporting requirements
  •  Interact with company departments including, Commercial Operations, Legal, Medical Affairs, Clinical Operations, Clinical Development, Regulatory Affairs, Quality Assurance, and Project Management 
  •  Represent the Pharmacovigilance Operations department at internal and external meetings


ESSENTIAL FUNCTIONS:
 To perform this job successfully an individual must be able to perform each essential function satisfactorily.
 Key responsibilities include the following:
  • Oversee the management of worldwide clinical and postmarketing pharmacovigilance operations activities. 
  • Oversee pharmacovigilance compliance with regulatory reporting requirements, corporate SOPs, and work instructions including international PV requirements and guidelines
  • Oversee generation and quality of safety reports generated from the Argus safety database in support of safety surveillance activities and aggregate safety reports. 
  • Oversee and/or manage pharmacovigilance operations activities in the preparation of key safety documents for regulatory authorities (e.g. EU RMP, PADER, PSUR, PBRER, periodic listings and safety update reports).
  •  Acts as a liaison and manages external global pharmacovigilance operations service provider(s) providing pharmacovigilance services
  •  Develop and/or maintain, review or approve pharmacovigilance related documents including Safety Management Plans, SOPs, Guidelines or work instructions, EU Pharmacovigilance System Master File, signal management plans, training, audit and inspection plans. 
  • Supports the EU QPPV and collaborates with Affiliates and Rest of World Counterparts as required by pharmacovigilance operations business needs
  • Provides pharmacovigilance representation and contributes to safety review committees or other internal committees
  •   Participates and contributes to activities associated with risk minimization measures (Updates to SmPC, package insert, leaflets, targeted questionnaires etc.)
  • Support the development and execution of Pharmacovigilance Agreements and Safety Data Exchange Agreements with vendors, Business Partners and other relevant parties.
  •  Other duties as assigned


 QUALIFICATIONS:
  •  RN, BSc or higher degree, e.g. MPH, Pharm D., is preferred.
  • 10+ years of experience in drug safety/pharmacovigilance 
  •  3+ years of line management experience
  • 5+ years in a pharmaceutical sponsor company is preferred
  •   Previous experience in Gastroenterology, hepatology or related field, preferred.


 REQUIRED KNOWLEDGE AND ABILITIES:
  •  Knowledge of and working experience with FDA postmarketing guidelines and regulations, EU GVP Modules, ICH guidelines, and EMA/CHMP regulations and guidelines, and other international regulatory requirements
  • Strong PV operational knowledge including experience with Individual Case safety report handling
  •  Extensive knowledge and experience with Argus safety database
  • Strong interpersonal and communication skills; proactive approach.  Able to work both independently and in a team environment.
  • Experience with managing pharmacovigilance personnel
  • 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 (<5%/year), in some cases internationally, may be required.