Pharmacovigilance Scientist

Highly Competitive
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United States
Somerville, Massachusetts
Posting date: 04 Jul 2019
QA.SH.24183_1562247873

An internationally leading pharmaceutical company is seeking to recruit a Pharmacovigilance Scientist to their office in London. Specialising in multiple therapy areas, the company boasts a superb pipeline with products that include treatments for diabetes, cancer and asthma. This is an exciting opportunity to work with a company that operates in over 90 countries across the globe.

Job Responsibilities:

  • QC of periodic reports and/or line-listings
  • Liaise with CROs and other relevant functional areas within TGRD
  • Represent pharmacovigilance department in cross-functional teams or committees that have global study or program impact
  • Working knowledge and understanding of designated products/studies
  • Conduct project activities for assigned developmental products
    • Set up of safety procedures including creation and maintenance of study summary documents
    • Review and provide functional area expertise for development of protocols, IBs, ICFs, DMP and other relevant project/study documents
    • Provide investigator and monitor training on safety procedures
    • Reconciliation of clinical and safety databases
    • Coding review of data from clinical study databases
    • Unblinding of individual study subjects and maintaining confidentiality
    • Create study specific pharmacovigilance plans with CROs
    • Draft annual safety report and compile other required periodic reports
    • Assist with ad hoc or routine safety monitoring activities
  • Support project activity as required for other developmental products
  • Project support activities for marketed products as required
    • Assist with narrative writing for periodic/ad hoc submissions
    • Assist with ad hoc or routine safety monitoring activities
  • Contribute to improvement of departmental processes
  • Any other tasks assigned by manager to assist in departmental activities

Skills and Requirements:

  • Registered nurse or degree level qualification (e.g. Bachelors degree) in scientific/medical field.
  • At least 5 years of experience in pharmacovigilance or equivalent demonstrated expertise in accountable activities.
  • Excellent databases and coding skills including ability to perform advanced searches.
  • In depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety profile, and risk/benefit analysis.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Sherron Howard at +1 267 435 8600 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-SH1

#Scientific

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