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.
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
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
: 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 /email@example.com\ for review before we speak.