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Pharmacovigilance Scientist

  • LocationManhattan, Gramercy Park and Murray Hill, NY 10016 - United States
  • Work TypeFull Time - Permanent
  • Positions1 Position
  • Published At:22 days ago


  • Job no: 37396
  • Categories: Clinical

Job Description

Our client, a leading biopharmaceutical company, is currently seeking an accomplished Pharmacovigilance Scientist to join the team. Here is an overview of the role:

1) Design and perform analysis of safety information for signal detection

2) Manage interface with drug safety meetings

3) Maintain a program plan of all activities and deliverables related to drug safety

4) Maintain a central repository for all matters related to drug safety

5) Manage the external PV services provider and account for the timely execution of contracted activities

6) Set up procedural standards for the conduct of PV activities across company

7) Ensure any PV Agreements/Safety Data Exchange Agreements with business partners comply with PV standards and are implemented and followed

8) Monitor compliance with regulatory and company standards for safety data management

9) Conduct root cause analysis of procedural deviations and implement CAPAs, as required

10) Maintain records of PV activities at the disposal of regulatory auditors

11) Support internal PV audits and regulatory inspections

12) Author, coordinate and review PV-related documents, including periodic reports, SMPs, SAE reconciliation plans, RMPs and RSIs

13) Educate the organization on critical developments and regulatory guidance related to drug safety

14) Represent drug safety in product team meetings and all activities where drug safety is critical to the success of company and its products

15) Pursue continuous improvement of the PV system, maintain up-to-date knowledge of international PV requirements and complete assigned training on time

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the biopharmaceutical industry is strongly preferred

4) Preference will be given to candidates with recent experience in research and development

This role is a great opportunity for the right person looking to advance their career with a wonderful company. If you are qualified and think that you are a strong fit for this role, please apply ASAP!

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience


  • Published on 15 Apr 2021, 1:41 PM