Pharmacovigilance Manager

Pharmacovigilance Manager

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 Position: Pharmacovigilance Manager

Location: Dayton, NJ

Duration: Fulltime Permanent

Our Client is looking for Pharmacovigilance Manager- with 1 year of experience!!!!

JOB SUMMARY:

This position will be responsible for ensuring compliance of the department with FDA regulations. The primary responsibility of this position is to ensure that all Adverse Drug Events (ADEs) and PSURs are being submitted to the FDA in a timely manner. This position as appropriate will develop and revise SOPs, training material and WPDs for the department. This position will take the lead role during any Regulatory inspections and Audits such as the FDA, Global Pharmacovigilance Audits. The position will be the primary contact for US PVG department and activities.

REPORTING RELATIONSHIPS:

Manages Pharmacovigilance Group with respect to daily functions. This position is responsible for assigning:

Responsibilities

Review of performance

Timecard approval

Employee Development

Budget Responsibilities

DUTIES & ESSENTIAL JOB FUNCTIONS:

General PVG Activities

Quality Control and management of Local Standard Operating Procedures (SOPs), including writing of training materials and WPDs

Primary contact for USA PVG

Overseeing the training of the department

Lead the FDA inspections and audits

Lead person for the inspection/audits of US PVG department

Participate in the inter-company audit of Global Pharmacovigilance Operations

Interact with our Parent Division in India to process Field Alerts

Review, Approve and Close Complaint Investigations

Review and Process VP Notifications which impact the PVG area

Prepare PVG Quality Performance Metrics and Represent the Department in Quality Council Meetings

Assure that all Customer Inquiries, Adverse Events and Complaints are processed in accordance with cGMP and company procedures/policies

Adverse Drug Event Handling

Ensuring that all potential adverse drug reactions received are processed without delay and in accordance with current SOPs and FDA guidelines

Handling and/or supervising communications with Health Care Professionals regarding ADE reports

Handling and/or supervising communications regarding Field Alert Reports

Reviewing and approving Periodic Safety Update Reports (PSURs)

Reviewing and approving Monthly Compliance Reports (MCRs)

Additional Responsibilities:

Primary contact for Ribavirin Pregnancy Exposure Registry

Responsible for the generation of department Budget.

Primary contact for Pregnancies Exposed to Antiepileptic Agents

Other responsibilities as assigned by Supervisor

QUALIFICATIONS AND SKILLS NEEDED:

Science Degree with Pharm. D. preferred

Ability to work well under pressure

Attention to detail

Strong computer skills

Excellent telephone manner

Previous job experience

Minimum one year is required with Pharm D degree

ANY REQUIRED LICENSES/CERTIFICATIONS:

Active Pharmacist License