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Senior Safety Surveillance Specialist Job

Eingestellt von Yoh

Gesuchte Skills: Support, Client

Projektbeschreibung

SENIOR SAFETY SURVEILLANCE SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in Wilmington, DE.

TOP SKILLS SHOULD YOU POSSESS:

- Patient Safety
- Safety Surveillance

WHAT YOU'LL BE DOING:

- Manage safety data using analytical skills, processing adverse event cases of all levels of business risk and/or providing scientific or technical input to Surveillance or Support section activities.
- Senior specialists require effective project management skills to deliver a project or piece of work for Clinical Drug Safety.
- Supports the work of the Patient Safety Physician
- Submits accurate aggregate safety reports in a timely fashion
- Assures the completeness and accuracy of data provided to the Patient Safety Physician
- Provides regulatory safety expertise to the clinical teams
- Facilitates Safety Surveillance Group meetings under the direction of the Patient Safety Physician
- Participates actively in pre-SERM review and prepares/assists in preparation of SERM discussion documents for the GSP
- Provides organizational and scientific direction in aggregate safety reports (PSUR/IPAR, etc.) preparation, assuring that all contributors complete their assignments in a proper and timely way and that domestic and global requirements and timelines are satisfied
- Provides organizational and scientific direction in preparation of responses to health authority queries assuring that all contributors complete their assignments in a proper and timely way and that domestic and global requirements and timelines are satisfied
- Obtains accurate denominator data for signal evaluation and review
- Provides safety expertise to clinical trial working groups and clinical development teams, and presents the SAE reporting process at Investigator Meetings as necessary

WHAT YOU NEED TO BRING TO THE TABLE:

- Advanced degree in science/healthcare-related field; or Bachelor's degree in science/healthcare-related field plus relevant equivalent experience.
- At least five years patient safety experience and/or at least five years clinical or pharmaceutical experience
- Excellent verbal and written communications skills
- Excellent presentation, personal and analytical skills

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a DayJ2W: SCIENTIFIC

MONJOBJ2WMIDATL

Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    Wilmington, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh