To execute, assist with and support all local safety related activities as directed by the Netherlands Head of Drug Safety
Ensure compliance with local and international regulations and the company its internal standards.
To oversee and execute timely local case-processing activities, including ensuring robust investigation and follow-up of local safety reports for both marketed products and those under development.
To oversee and execute timely and accurate reporting to the national competent authorities.
To contribute effectively as part of the company its Global Safety network
To ensure the accurate, timely and complete receipt, evaluation and follow- up of domestic adverse event reports
To translate Dutch source information to English
Screens local literature for relevant safety information
To maintain the local archives of safety reports and quality complaints
To maintain current awareness of local and global safety regulations
To ensure compliance with local expedited and periodic regulatory reporting requirements for marketed products and those under development, utilizing ARISg, E2B and email.
To contribute to the development and maintenance of corporate policies, standard operating procedures and associated documents on safety data handling.
To assist with training of the affiliate organisation and associated third parties on safety data reporting requirements
To capture, follow-up and ensure the appropriate persons within this company are notified of locally reported Product Quality Complaints, in line with the international and national SOP’s for Drug Product Complaints.
To assist with the development, implementation and follow-up of the Risk Management Programs (RMP) for relevant the products in The Netherlands.
Together with other medical colleagues man and manage an emergency telephone line (24/7).
| De eisen
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Relevant life science/pharmacy degree or registered nurse
Must be able to innovate, analyze and solve problems with minimal supervision
Attention to detail
Be able to work independently and as part of a team
Excellent communication skills (verbal and written) in English and Dutch
Domestic and International travel may be necessary.
| De arbeidsvoorwaarden
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| | Contactinformatie
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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 |
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