Pharmacovigilance Leader Job

PHARMACOVIGILANCE LEADER needed for a CONTRACT opportunity with Yoh's client located in East Hanover, NJ.

WHAT YOU'LL BE DOING:

- Performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of the line listings of single cases and preparation of investigator notifications.
- Identifies safety signals based on the review of solicited or unsolicited single cases.
- Performs signal detection monitoring and evaluation based on single cases, aggregate data and signal detection tools, ie EMPIRICA
- Prepares clinical expert statements and provides input in responses to inquiries from regulatory authorities or healthcare professionals on safety issues.
- Prepares safety data for health authority review boards.
- Provides input to responses for legal queries and CPO requests involving safety issues
- Provides Pharmacovigilance input to initial development of basic prescribing information and is responsible for Pharmacovigilance input into updates of this information
- Prepares medical input to aggregate clinical safety regulatory reports
- Provide input to safety profiling and risk management plan
- Provide guidance as appropriate to Clinical Safety Operations for the coding and causality/expectedness assessment of adverse event reports
- Provide expert evaluation on the clinical context of adverse event report, assessment on the medical conditions and the implications on Novartis drugs
- Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments
- Provides relevant input for internal and external boars and expert panels as well as internal management teams as SPT, SMT, GPT as needed.
- Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.

WHAT YOU NEED TO BRING TO THE TABLE:

- PharmD, RN or related field
- Five (5) plus years of experience in Pharmacovigilance

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

J2W: CLINICAL

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