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Drug Safety Associate Job

Eingestellt von Yoh

Gesuchte Skills: Marketing, Client

Projektbeschreibung

DRUG SAFETY ASSOCIATE needed for a CONTRACT opportunity with Yoh's client located in Collegeville, PA area.

WHAT YOU'LL BE DOING:

- Responsible for the continued safety assessment, evaluation and risk management of major GSK products or product groups in clinical development and/or the post-marketing setting
- Ensures that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labeling updates, and drive proactive implementation of risk management initiatives
- Provides significant and proactive clinical safety input on cross-functional teams (including Safety Review Teams) and ensures that appropriate safety objectives and risk minimization strategies are included in clinical development programs

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelors, or above, degree in Biomedical or Health Care related specialty
- Advanced evaluation skills and analytical thinking for scientific literature review, data gathering, data synthesis, analysis and interpretation
- Strong medical/scientific writing skills
- Sound computing skills
- In depth knowledge of relevant Pharmacovigilance regulations and methodologies applicable to SERM activities.
- In depth understanding and experience of causality assessment, evaluation of safety signals and of proactive risk management strategies, including management of labeling changes, physician and patient education and monitoring of safety issues
- Sound knowledge of therapy areas of assigned products Knowledge of other relevant disciplines (eg statistics, pharmacoepidemiology and associated methodologies) pertinent to assessing drug utilization and safety at the population level
- Sound knowledge of medical and drug terminology
- Clear understanding of drug development process and the drug approval process in major countries

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

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Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    Collegeville, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh