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Graduated Plan Officer

  1. Central Germany
Berlin
  1. Contract
Competitive
  1. CAPEX Projects
30-05-2024
32450
Graduated Plan Officer - Germany - 6-Month Contract 

Our client, a prominent consulting and solutions firm specialising in risk management and compliance services for the pharmaceutical industry, has been driving advancements in the development-to-market process with efficiency and innovation since 2008.

They offer comprehensive global services that cover the entire product life cycle, including Clinical, post-submission Regulatory Affairs, Pharmacovigilance, Quality Assurance, Auditing, and cutting-edge automation solutions.


Responsibilities: 
  • Oversight over the functioning of the system in all relevant aspects, if the responsibility is not delegated to EU QPPV, including its quality system (e.g., standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance);
  • Close cooperation with the marketing authorisation holder as well as related departments and functions, as applicable;
  • Close cooperation with the Deputy GPO.

Requirements:
  • Bachelor's degree or graduate in pharmaceutical sciences or related fields - medicine, pharmacy, life sciences - advanced degree (e.g., masters) preferable
  • Minimum of 5 years of experience working in a medical or safety department with demonstrable expert knowledge of medical terminology
  • Previous experience as GPO, previous experience as Qualified person responsible for pharmacovigilance in Switzerland strongly preferred
  • Previous experience in business development and sales area preferred
  • Detailed knowledge of PV processes, directives, regulations, and guidelines, with the emphasis on German pharmacovigilance requirement, strong understanding of Swiss and possibly Austrian pharmacovigilance requirement strongly preferred
  • Experience working with a safety database
  • Knowledge of web-based communication tools for conferencing (Skype/Teams, WebEx, etc.)
  • Fluent verbal and written English and German – additional knowledge of French preferable

If this role is of interest to you, please apply now! 

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