Pharmacovigilance Associate Job

PHARMACOVIGILANCE ASSOCIATE needed for a CONTRACT opportunity with Yoh's client located in Cambridge, MA.

WHAT YOU'LL BE DOING:

- 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.

WHAT YOU NEED TO BRING TO THE TABLE:

- A Bachelor's in life sciences or Pharmacy with a minimum of one to two (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, eg 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
- 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

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

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