Eversana Hiring for Program Manager Pharmacovigilance Operations

Eversana Hiring for Program Manager Pharmacovigilance Operations

4 February, 2022

About the job

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Job Description

  • Assume responsibility for management of client and client products.
  • Serve as a resource for pharmacovigilance team on the procedures and processes for adverse event processing and aggregate reports for the client.
  • Act as a company liaison with client to manage all issues related to services provided by EVERSANA PV
  • Manage required training to the PV team
  • Monitor timelines of the PV project and key performance indicators (KPI)
  • Monitor the project budget and alert management if updates to the Statement of Work are required.
  • Address any quality issues with the client.
  • Lead the PV team on any changes to the client’s requirements.
  • Ensure regulatory compliance with timelines for individual expedited case report submissions and provide assistance and timely delivery of information for aggregate reports, ad hoc report compilations, and other regulatory documents as requested
  • Interact with the client and/or other stakeholders for the purpose of safety data collection, data reconciliation, etc.
  • Conduct periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies with little or no supervision.
  • In addition to case management projects, this individual may also participate in the development of other EVERSANA-PV and client documents such as signal trending/detection reports, aggregate reports, safety management plans, standard operating procedures, and work instructions.
  • May perform active follow-up via telephone contact with consumers and health care professionals for the client projects.
  • May work with client Clinical Research, sometimes in a lead capacity, regarding Safety Data Exchange Agreements (SDEA).
  • Lead team members, e.g., Drug Safety Coordinators, Drug Safety Associates, to facilitate efficient case processing
  • All other duties as assigned

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

  • BS degree in a life science discipline (e.g., pharmacy, nursing) is preferred
  • At least 6 years of relevant experience, which includes 3 years in drug safety
  • Broad knowledge of domestic and international drug safety regulations, industry practices and standards
  • Strong attention to detail, teamwork, and initiative
  • Strong understanding of drug development, drug safety reporting, as well as an appreciation for the importance of regulatory compliance
  • Excellent working knowledge of MedDRA and WHODRUG coding dictionaries
  • Familiarity with FDA, EMA, Health Canada and international adverse event reporting regulations per ICH guidelines

PREFERRED QUALIFICATIONS:

  • Must be quality oriented and demonstrate consistent attention to detail
  • Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
  • Must have good planning and organizational skills
  • Understanding of medical terminology and familiarity with principles of adverse event reporting in the pharmaceutical industry is a plus
  • Knowledge of relevant software including safety database and Microsoft Office

Apply through below link

Program Manager Pharmacovigilance Operations | EVERSANA | LinkedIn

2Comments

  • I am graduate in B Pharm from Mallige college of pharmacy under Rajiv Gandhi University. I am fresher. I have been proficient academic student throughout B Pharm with 8.54 SGPA. I am actively looking for a job opportunity in pharmacovigilance.

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