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Associate Director, Pharmacovigilance Operations

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Associate Director, Pharmacovigilance Operations Company: The American College of Radiation Oncology

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Associate Director, Pharmacovigilance Operations

Associate Director, Pharmacovigilance Operations Cambridge,Massachusetts, United States

1 day ago

Description

Associate Director, Pharmacovigilance Operations will work onprojects and processes that ensure the strategies of the departmentare executed within global safety legislation and requirements. Todo this the Associate Director, Pharmacovigilance Operations willbe responsible for activities within PV Operations and Compliance,as well as support Medical Safety, as needed.

Responsibilities Participates in the review and execution of PVOperations safety data collection and processing strategy acrossprograms.

Provides oversight and review of vendor activities, includingcase processing, and aggregate reports. Oversight activitiesinclude monitoring compliance, effective communication andimplementation of corrective and preventive actions, as needed.

Actively participates in the quality review of SAEs and SUSARsfollowing data entry by vendor.

Responsible for managing aggregate report processes to ensuretimeliness, completeness and quality.

Responsible for managing cross-functional activities to ensureand promote compliance with pharmacovigilance standards andoperational consistency across clinical trials.

Participates in the creation and dissemination of appropriatesafety reporting language in clinical trial key documents.

Accountable for reconciliation activities to ensure reporting ofall adverse event data.

Actively participates in and manages cross functional projectsthat develop and support strong cross-functional relationships andcommunication.

Maintains knowledge of adverse event reporting process andsafety system and contributes to the development, improvement andstandardization of new processes and methods.

Contributes to projects which involve the implementation of newprocesses and methods.

Undertakes activities necessary to be inspection ready.

Supports signaling, medical safety and safety managementteams.

Other duties as assigned.

Qualifications Bachelor’s degree in nursing, pharmacy, or otherlife sciences required. Master’s degree, preferred.

5-7 years of Drug Safety and Pharmacovigilance experience.

Knowledge of FDA, ICH, EU Regulations and Requirements forPharmacovigilance required.

Experience using ARISg, Argus or other Safety Databaseapplications.

Location:

Cambridge, Massachusetts, United States

Position Title: Associate Director, PharmacovigilanceOperations

Sumitomo Dainippon Pharma Oncology, Inc. is a developer of novelcancer therapeutics based in the U.S. and a wholly owned subsidiaryof Sumitomo Dainippon Pharma Co., Ltd. This U.S. entity, togetherwith the oncology research and development teams in Japan, DSPCancer Institute and Oncology Clinical Development Unit, willcollectively be known as Sumitomo Dainippon Pharma Oncology or SDPOncology. SDP Oncology is relentlessly committed to advancingpurposeful science by transforming new discoveries into meaningfultrea...

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Keywords: The American College of Radiation Oncology, Waltham , Associate Director, Pharmacovigilance Operations, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Associate Director, Pharmacovigilance Operations, Other , Cambridge, Massachusetts

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