Graduated Plan Officer

Quanta part of QCS Staffing; Berlin; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A prominent consulting firm is seeking a Graduated Plan Officer for a 6-month contract in Berlin, Germany. The role involves oversight of the pharmacovigilance quality system and ensuring compliance with German regulations. Candidates should possess a Bachelor's degree in pharmaceutical sciences, have at least 5 years of experience in safety departments, and be fluent in both English and German. This contract offers an exciting opportunity to work in a dynamic environment focused on innovation in the pharmaceutical industry.

Qualifikationen

• Minimum of 5 years of experience in a medical or safety department.
• Previous experience as GPO and Qualified person responsible for pharmacovigilance is preferred.
• Detailed knowledge of German pharmacovigilance requirements.

Aufgaben

• Oversight over the quality system and compliance data.
• Cooperation with the marketing authorisation holder and related departments.
• Collaboration with the Deputy GPO.

Kenntnisse

Fluent English

Fluent German

Knowledge of PV processes

Medical terminology expertise

Experience with safety databases

Ausbildung

Bachelor's degree in pharmaceutical sciences or related fields

Advanced degree (e.g., master's)

Tools

Web-based communication tools (Skype / Teams, WebEx)

Jobbeschreibung

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 .

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.

Qualifications

• 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!