Senior Pharmacovigilance Auditor (m/w/d), home or office based

Hamburg
27.10.2020

Daten dieser Anzeige

Senior Pharmacovigilance Auditor (m/w/d), home or office based

Germany

http://www.experteer.de/account/signup_now/sueddeutsche_hamburg/23390855?utm_medium=metasearch&utm_source=sueddeutsche&utm_content=job&utm_campaign=sueddeutsche%2Bhamburg&v_signup_style_v4=true

Description

TFS is a Global CRO headquartered in Sweden. We genuinely believe that “Global in mind and local at heart” is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.

The Senior Quality Manager is a senior position in the Quality & Compliance Department.

The Senior Quality Manager is capable of independently conducting work related to the development, improvement and daily management TFS QMS as well as conducting all types of GxP audits including system audits according to TFS policies, SOPs and regulatory requirements.

This person has a broad experience in clinical research and quality management and is able to provide support and advice throughout this area.

This position can be home or office based in one of TFS locations in Europe:

Key responsibilities:

- Prepare, conduct and follow up on all types of internal and external GxP audits including system/process audits, vendor audits, investigator site audits, and pharmacovigilance audits, TMF audits, document audits (e.g. CSRs), database audits, CSV / computerized system audits
- Provide quality management advice and support to internal and external customers
- Support and guide operational staff in preparing for customer audits and regulatory inspections
- Support, guide and facilitate customer audits including system/process/qualification audits and regulatory inspections
- Peer review of audit reports
- Act as Quality Lead auditor when applicable
- Train other Quality & Compliance personnel as required
- Participate in internal meetings as required and liaise with other departments as necessary
- Actively and independently contribute to the development and improvement of TFS Quality
- Management System (QMS)
- Actively contribute to continuous improvement of the organisation and processes/procedures development of to enhance the work at TFS
- Develop new and review existing Quality & Compliance SOPs as required
- Maintain required knowledge of applicable regulations and company GxP standards and procedures
- Assist in writing SOPs for other departments
- Assist in providing input into proposals, which include Quality & Compliance
- Assist with business development of external Quality & Compliance services
- Accompany Commercial Operations colleagues on customer visits and participate in presentations when required
- Act as trainer within scope of knowledge and expertize

### Requirements

- University/college degree or equivalent industry experience
- Awareness of global and local industry trends, government policies and regulations in the clinical trials and pharmacovigilance area

**- In depth knowledge of GxP regulations and guidance
- Previous pharmacovigilance auditing experience is required, with thorough knowledge of requirements for PV compliance Knowledge on GxP regulated computerized system validation activities and principles
- Previous audit management experience
- Good computer skills (Microsoft Word and Excel)
- Ability to work independently and efficiently
- Good planning, organisation and problem solving abilities
- Fluent in English, both written and verbal
- Several years’ experience in clinical research, (e.g. monitoring, data management, drug safety, training, etc.)
- Five to ten years’ experience of auditing in two to three GxP areas
- International travel to audit sites, worldwide
- Membership of a quality association (e.g. the Research Quality Association) is considered as an advantage
- Delegated for other tasks and activities by Quality Operations Director within scope of experience

Benefits

  • Entrusted work time
  • Corporate Pension Plan
  • Global General Liability Insurance
  • Global Travel Insurance

Job Summary

  • ID: 71995E7D6F
  • Department: [“Quality Assurance”]
  • Type: full time**

Transport/ Logistik/ Materialwirtschaft

Sonstige Branchen

Bereichs-/ Abteilungs-/ Gruppenleitung

Hamburg