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: (Right to Hire) Fulltime Permanent
Our Client is looking for a 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 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 and Global Pharmacovigilance Audits. The position will be the primary contact for the US PVG department and activities.
REPORTING RELATIONSHIPS:
Manages the Pharmacovigilance Group with respect to daily functions. This position is responsible for assigning:
- Review of performance
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
- 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
QUALIFICATIONS AND SKILLS NEEDED:
- Science Degree with Pharm. D. preferred
- Ability to work well under pressure
- Attention to detail
- Minimum one year is required with Pharm D degree
ANY REQUIRED LICENSES/CERTIFICATIONS:
Additional Information
Regards,
Clinical Recruiter
Integrated Resources, Inc.
Tel: 732 429 1636
(W) 732-549-2030 x 214 | (F) 732-549-5549
Gold Seal JCAHO Certified for Health Care Staffing
“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
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