Pharmacovigilance Manager

A Few Words About Us

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy, and Nursing.

Job Description

Job Position: Pharmacovigilance Manager

Location: Dayton, NJ

Duration: Full-time Permanent (Right to Hire)

Our Client is looking for a Pharmacovigilance Manager with at least 1 year of experience.

Job Summary

This position will be responsible for ensuring compliance with FDA regulations within the department. The primary responsibility is to ensure that all Adverse Drug Events (ADEs) and PSURs are submitted to the FDA in a timely manner. The role includes developing and revising SOPs, training materials, and WPDs for the department. The Pharmacovigilance Manager will lead during regulatory inspections and audits such as FDA and global pharmacovigilance audits. This position will serve as the primary contact for the US PVG department and activities.

Reporting Relationships

Manages the Pharmacovigilance Group regarding daily functions, including performance review and task assignment.

Duties & Essential Job Functions

• Manage general PVG activities and quality control of SOPs, including writing training materials and WPDs.
• Serve as the primary contact for USA PVG.
• Oversee training of the department.
• Lead FDA inspections and audits.
• Participate in inter-company audits of Global Pharmacovigilance Operations.
• Coordinate with the parent division in India for Field Alerts.
• Review, approve, and close complaint investigations.
• Review and process VP notifications impacting PVG.
• Prepare PVG quality performance metrics and represent the department in quality council meetings.
• Ensure timely processing of customer inquiries, adverse events, and complaints in accordance with cGMP and company policies.
• Handle communications with healthcare professionals regarding ADE reports and field alert reports.
• Review and approve PSURs and MCRs.
• Additional responsibilities include managing the Ribavirin Pregnancy Exposure Registry and the Pregnancies Exposed to Antiepileptic Agents program, as well as departmental budgeting and other tasks as assigned.

Qualifications

• Science Degree with Pharm.D. preferred.
• Ability to work well under pressure and attention to detail.
• Minimum one year of experience with a Pharm.D. degree.

Additional Information

Regards,

Clinical Recruiter

Integrated Resources, Inc.

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