Pharmacovigilance Manager

Job Position: Pharmacovigilance Manager

Location: Dayton, NJ

Duration: ( Right to Hire) 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, h•aining 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 h•aining 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 Meh•ics and Represent the Department in Quality Council Meetings

• Assure that all Customer Inqureries, 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