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PV Scientist

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support, Marketing

Projektbeschreibung

The individual will be required to do the following:

Evaluation of safety data (and efficacy data as appropriate) for assigned products
Under guidance of and approval of MSO, prepare, draft and write ad hoc responses to regulatory queries and aggregate safety assessment reports.

Under guidance of the Medical Safety Officer (MSO) initiate as appropriate searches of company post-marketing database and related pharmacovigilance sources such as but not limited to scientific literature and Health Authority databases.

Review individual case reports series and aggregate safety data.

Co- ordinate preparation of ad hoc safety reports by vendors and Global Medical Safety (GMS).

Ensures that each safety issue is assessed within agreed timelines and communicated to stakeholders

Ensures filing of the developed documentation.

Assists in the development of Risk Management Plans.
Contributes to the development of labelling for assigned products.
Contributes to the development of surveillance/data assessment tools in support of ad hoc surveillance.

It is important that the succesful candidate has aggregate writing experience (PSURs, CCDSs, labelling documents, clinical trial reports etc).

The individual must have a bio science degree, pharmacy or nursing degree and must have experience in pharmaceutical medicine, including in drug safety.

A sound knowledge of regulatory requirements for pharmacovigilance globally.
Good communication skills, both written and verbal.

To find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland