Home   Register   Sign In
 
Company Info

MaxisIT

203 Main Street Metuchen, NJ 08840
Woodcliff Lake, NJ, United States

Phone: 732-276-9940
Web Site:

Company Profile


Pharmacovigilance Compliance associate


col-narrow-left   

Job ID:

5109

Location:

Cambridge, MA, United States 

Category:

Biotech, Health-Care, Pharmaceutical, Science

Salary:

N/A per hour
col-narrow-right   

Job Views:

518

Zip Code:

02142

Employment Type:

Contract - W2

Posted:

10.01.2014
col-wide   

Job Description:

Job Description:
 
In the liable business area pertaining to compliance monitoring of timelines for processing/regulatory reporting of safety reports, the primary function of the Pharmacovigilance Compliance associate’s (PCA) role is to:
  • Contribute to the development, production and maintenance of the appropriate
    tracking and compliance tools, reports, plans, tasks and activities pertaining to the
    management of the GPE compliance management system.
  • Perform data entry, deviation closure and reconciliation activities in the global compliance database.
  • Perform follow-up on pending Corrective and Preventive Actions (CAPAs) and ensure implementation of the same in the Global compliance database.
  • Perform compliance data analysis using available tools to identify potential trends
  • Track and communicate on compliance
  • Manage and update compliance documents in the SharePoint repository
  • Support Affiliates on compliance matters as required
  • Support the conduct of PV audits/regulatory inspections
  • Participate to the Development of compliance programs and quality tools to enhance GPE global quality and adherence to SOPs and Regulations.
 
Skills:
 
Knowledge of Individual Case Safety Reports (ICSR) management processes including case receipt, case processing, medical review and regulatory submission.
  • Knowledge of compliance international Regulations and ICH environment foundations
  • Knowledge of safety databases like AWARE, ARGUS etc.
  • Proficiency in Microsoft Excel, PowerPoint, Word, Access, Visio.
  • Knowledge of quality databases, SharePoint and SQL queries will be a plus.
  • Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
  • Able to manage both time and priority constraints and to manage multiple priorities simultaneously
  • Attention to details
  • Proven ability to work in international environment and cross-functional team, with good interpersonal skills / assertiveness / team spirit / caching skills
 
Education:
 
A Bachelor’s in life sciences or Pharmacy with a minimum of 1-2 years of experience in Pharmacovigilance activities related to ICSRs/periodic reports/Signal detection.
  • In depth understanding of international pharmacovigilance requirements/updates in particular EU/FDA requirements/international guidelines, e.g. ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines (GCP) and regulation
  • An additional degree in pharmaceutical regulatory environment, or in business management or in quality management would be much appreciated.
  • Creativity to propose/create/supervise appropriate tools to support business activity
  • Writing quality documents
  • Project/time management/training
 
Location: Cambridge, MA.
Contact: Venkata Giri

The best telephone number to reach me is 732-276-9940 Ext: 325. I appreciate if you forward your updated word formatted resume at /varahavenkata.d@maxisit.com\ for review before we speak.


© 2017 Powered by Rootjobs     About Us   Sitemap   Terms and Conditions   Privacy Policy   Mobile Version     Twitter RSS LinkedIn Facebook