Pharmacovigilance Leader

Artech Information System LLC; East Hanover (NJ); On-site; USD 90,000 - 110,000; Full time

Job summary

A leading IT staffing company in New Jersey is seeking an experienced professional in pharmacovigilance. The role involves conducting medical assessments, preparing safety data for regulatory review, and collaborating with various departments to ensure compliance with safety standards. Candidates should have at least 3 years of specific Pharma Industry experience and a strong understanding of signal detection and clinical assessments. This position offers a unique opportunity to influence medication safety and regulatory practices.

Qualifications

• 3 years of specific Pharma Industry experience required.
• Expertise in signal detection and evaluation.
• Experience with regulatory authority inquiries.

Responsibilities

• Perform medical assessments and evaluations.
• Prepare safety data for health authority review boards.
• Provide input on clinical safety regulatory reports.

Skills

Pharmacovigilance expertise

Clinical assessment

Signal detection monitoring

Regulatory compliance

Collaboration skills

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

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, i.e. 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 Client 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.

Skills:

3 years Specific Pharma Industry experience required