Wij zijn gespecialiseerd in functies binnen de farmaceutische industrie. Wij bemiddelen starters en ervaren kandidaten met een life science achtergrond.

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Drug Safety Officer (per direct, tijdelijk)

Deze vacature staat offline!

De opdrachtgever

Farmaceut omgeving Utrecht

Summary of Position

The Pharmacovigilance Officer supervises and coordinates all Pharmacovigilance activities, including all Adverse Events, Product Quality Complaints and non-complaint product related issues, independent of seriousness/complexity. He/she is qualified to function independently in the processing of these reports (including receipt, assessment of seriousness/labeling, prioritization and requesting follow-up) based on local/regulatory requirements. He/she is responsible for preparing of the applicable documents for submission of those reports to the Regional Center, license partners and/or health Authorities.
The Pharmacovigilance Officer is responsible for handling all safety (update) submissions from clinical trials to the Health Authorities, Ethical Commissions and/or investigators. He/she is responsible for preparing the applicable documents for submission of those reports within timelines set forth in local/global regulations and legislation.

De eisen

Good scientific knowledge (University degree in Medical Science).
Knowledge of regulatory requirements for safety reporting and labeling.
The ability to learn the products quickly.
Good project management and time management skills/prioritizing.
Fluent in Dutch and English, both spoken and written.
Use of Computer Microsoft Office package, database skills and web based search engines.
Good communicator.

Contactinformatie

Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:

Dr. Arjan van den Wijngaard
Consultant Medical
Biltstraat 443
3572 AW Utrecht
tel 030 231 7350
mobiel 06 50650550

Geïnteresseerden kunnen hun c.v. ook rechtstreeks mailen naar arjan@pharmamediair.nl.