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Job Details

Pharmacovigilance Officer level 2 (Drug Safety)

Company: Chiltern
Location: Home or office based in the U.S.
Reference: 7233
Closing Date: 17 Sep 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

The Pharmacovigilance Officer Level 2 (PVOL2) must use his/her experience as a ‘knowledge resource’ for the department and to help junior team members develop their skills both individually and as a team. The PVOL2, with the Line Manager, Senior Pharmacovigilance Officers and Clinical Research Physician will help identify potential areas for improvement within departmental and/or study specific processes and facilitate the necessary changes.

Requirements:

Job Background

 

The PVOL2 will be responsible for the set-up of partial service studies and full-service studies (with guidance from senior members of the team). The PVOL2 will act as lead on partial and full-service studies.

They may be called upon to interact independently with Sponsors and those directly involved in their projects, to assist in wider departmental tasks and to keep the Sponsor and other team members aware of any action changes. They may also be involved in supporting Business Development in the acquisition of new projects.

 

PRINCIPAL ACCOUNTABILITIES AND RESPONSIBILITIES

  • To act as Pharmacovigilance Officer as defined in the budget and schedule of responsibilities agreed with the client
  • When appropriate, in conjunction with the sponsor, to review pharmacovigilance aspects of  a given study
  • When appropriate, to write or advise on pharmacovigilance sections for the protocol and/or other documents
  • To write and/or review SAE narratives and CIOMS Forms for the Pharmacovigilance department
  • To provide 24 hour coverage on a rotational system for the Pharmacovigilance department, if contracted on projects
  • To discuss, when appropriate with the sponsor or Chiltern Medical team, any issues arising from adverse events reported to Pharmacovigilance
  • To provide pharmacovigilance advice for Chiltern staff and the Medical department
  • To be aware of and to comply with regulations and timelines associated with reporting SAEs to Regulatory Authorities, Ethics Committees, Investigators and EudraVigilance
  • To provide Pharmacovigilance advice to the Clinical Monitoring Department, BD, or other departments.
  • To represent the Pharmacovigilance department within the company and also at face to face client meetings
  • To personally undertake continuous educational training by reading and assimilating subject relevant Regulations, Directives, Guidelines and any applicable national legislation

 

QUALIFICATIONS:

  • Experience as a Pharmacovigilance Officer with a role in studies in a variety of phases, therapeutic areas and service levels
  • Ability for working independently with minimal supervision
  • Proven experience of good interpersonal and communication skills when dealing with Sponsors and supporting colleagues
  • Ability to organize and oversee multiple ongoing tasks and to understand the differing priorities
  • Confidence dealing with external and internal clients and providers
  • Good oral and written communication, organizational skills and personal presentation. The ability to communicate effectively in English
  • Life Science degree preferred

Salary

depends upon expereince

Position Type

Permanent
Full Time

Contact

Email Michelle Gerardi - Michelle.Gerardi@Chiltern.com
+1 774 272 5506

Apply for this job: Pharmacovigilance Officer level 2 (Drug Safety)

Contact Information:

Address:  Illinois, USA
1425 Tri-State Parkway, Suite 110 Gurnee, USA
IL 60031
USA
Website:  Visit Our Web Site

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