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Safety Surveillance Officer - Denmark

Ongoing safety surveillance of my clients products during pre-approval and post-approval phases.
Establishment, operation and chairmanship of internal our clients cross-functional Safety Committees

Ongoing systematic review of safety information to detect and investigate safety signals in order to establish and update safety profile of our clients products and take action if required.

Establish contact with and cooperate with external clinical experts individually or in Data Monitoring Committees.

Secure appropriate medical interpretation and evaluation of adverse events and other safety information reported from world-wide sources.

Communication of drug safety issues internally and to health authorities.

Secure compliance with drug safety legal requirements and guidelines.

Key qualifications (minimum requirements):

Medical Doctor, Master degree in Pharmacy or equivalent medical and scientific background

Experience:

Documented scientific experience, preferably from the pharmaceutical industry

Documented experience with evaluation of drug safety and/or with pharmacoepidemiology, including a good knowledge of international legal requirements for drug safety vigilance and reporting.

A good knowledge of clinical development

An extremely good knowledge of diseases, their clinical manifestations, treatment and complications

A good knowledge of clinical pharmacology

A good knowledge of computers and databases

Fluent English, both written and spoken

Tasks

Medical evaluation and surveillance of all available safety information to detect and investigate safety signals and alerts in order to initiate action within due diligence.

Proactive design and establishment of the safety set-up for collection of safety information in clinical trials as well as definition of specific data elements for post-marketing reports.

Cross-functional and multidisciplinary co-operation within our clients Safety Committees as well as with other departments in HQ and affiliates. When required, contact to external experts is to be established to obtain external and independent expert advice.

The tasks demand a large professional and scientific insight, self dependence, professional authority, competence in decision making, as well as flexibility and excellent co-operation in an international environment.