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Senior Data Assurance Officer

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Introductie

Temporary senior position for four months at the Global Pharmacovigilance Process Department (Leiden, the Netherlands)


Het bedrijf / The company

The organisation is an international pharmaceutical organisation that has been operating in over 40 countries across Europe, the middle east and Africa. They operate on a global level and most of the teams have a global focus. They do everything in-house: Research, Development, Manufacturing, Warehousing and also Sales and Marketing. It is their hope to change tomorrow’s world and to improve the lives of individuals by providing innovative medicines where there is urgent need for better treatments. The organisation is clearly focused on bringing high-quality medicines to the market to reach their goals. Wouldn`t it be lovely to join them in their journey? At this moment they are open to meet an enthusiastic candidate for a temporary position as Senior Data Assurance Officer at their office in Leiden.

De functie / The role

In the role of Senior Data Assurance Officer you will be responsible for the maintenance of excellency in Regional Process Data Assurance and Medical Consistency. Thereby, you will be responsible for the implementation and execution of various QC measures in ICSR processing, which will contribute to the successful implementation of Regional Pharmacovigilance Process Management goals and objectives. Furthermore, you will ensure that the quality of contracted work is delivered to the Global Pharmacovigilance (GPV). The Process Management Office and you will be responsible for executing all in-house activities on time and with a high quality to ensure compliance with regulatory requirements and organisations policies. Also, you have to oversee triage, review and processing of Individual Literature Case Reports. In this position you will work extensively with vendor personnel and PV process staff within the region to ensure the high data quality required to support the ongoing assurance of the safety profile of organisations products and compliance. You will communicate with internal and external parties and you will be responsible for day-to-day maintenance of the EU safety mailbox. This means that you will be responsible for the development and maintenance of effective collaborations with internal Global Pharmacovigilance (GPV) stakeholders.

Het profiel / Your profile

• Master degree in Life Sciences or equivalent.
• Five years of relevant experience.
• In-depth knowledge and understanding of PV Process regulatory requirements and ICSR processing procedures both globally and in the assigned region.
• Technical expert who has the ability to recommend enhancements to internal policies, processes and procedures based on new requirements and legislation.
• Able to maintain case processing and case quality at the highest standards at all times.
• Ability to work independently and providing solutions to a wide variety of cases.
• Strong interpersonal skills, and multicultural and intercultural awareness.
• Strong communication skills in English (both written and spoken).


Het aanbod / The offer

• An amazing opportunity where you can use your skills and experience.
• A quality-orientated organisation in the pharmaceutical industry.
• Working in an international environment.
• A temporary contract or an independent contract from Derks & Derks.
• A contract until February 2021.


Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-087-DDD, to Sandra van Putten: info@derksenderks.nl.
For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.
An individual assessment may be part of the selection procedure.
Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.



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Gegevens

Werkgever:
Derks & Derks Detachering
Vacaturesteller:
Derks & Derks Detachering
Standplaats:
Leiden

Geplaatst op FMF: 28 augustus 2020

Branche: Farma & Biotech
Functie: QA / regulatory
Opleidingsniveau: WO/academisch / MSc, PhD
Werkervaring: 5-10 jaar, > 10 jaar