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Drug Safety Scientist x2

Eingestellt von Key People

Gesuchte Skills: Support, Client

Projektbeschreibung

Our global client is looking for x2 Drug Safety Scientists to join their team on a 12 months contract. To be considered for this role, you will need to have some at around 2-3 years PV experience. If you have experience of working with PV reports, it would be advantageous however it is not essential. You will also need to be available either immediately or at very short notice as the start date for both these contract is 5th November.

Safety Management and Reporting. T
The coordination of safety reporting requirements as required for MAH and/or study sponsor, as applicable.
Collection, review and reporting of Adverse Events (AEs) and pregnancy reports obtained through spontaneous reporting, solicited reports, clinical study, Local Health Authorities (LHAs) and other potential sources.
Assist with initial quality review and assessment of individual cases.
Co-ordinate/perform the follow-up of missing information from the AE reporter.
Provision of local data as required to support the preparation of Safety Summary reports (PSURs, ASR, etc).
Assist in the implementation of compliance standards and facilitate the collection of compliance metrics as required.
Ensure that day-to-day PV functions are performed satisfactorily and that full regulatory compliance is maintained at the Local Operating Company (LOC) level.

Awareness of and familiarity with industry principles of drug development and pharmacology. Computer literate ideally with some knowledge of database systems.
Good verbal and written communication skills.
Ability to negotiate and communicate with internal and external customers.
Biological sciences degree and/or equivalent proven expertise and experience in pharmaceutical regulations and R&D processes

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Key People