Manager, Drug Safety Operations - San Carlos, CA | Biospace
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Manager, Drug Safety Operations

Iovance Biotherapeutics, Inc.

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Location:
San Carlos, CA
Posted Date:
7/12/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Drug Safety, Manager, Operations,

Job Description


Overview

This position is responsible for vendor management activities related to clinical case management and submission activities. This individual will collaborate cross-functionally at all levels in the organization as well as externally with vendors and business partners. He/she will also have case management activities for applicable studies and will work together with the Director, Drug Safety Operations to manage the safety assessment of Iovance product(s).

Specific Responsibilities

•   Provide oversight for day-to-day interaction with PV vendor(s) and in compliance with Iovance vendor management processes.
•   Review and/or assist in the development of new standard operating procedures and work practices.
•   Manage communication and timelines with applicable partners and collaborative sponsors to ensure timely exchange of safety information.
•   Represent Drug Safety Operations for various cross-functional clinical study teams.
•   Review of scientific literature for safety signals/trends.
•   Process clinical cases from unsponsored studies.
•   May provide and prepare sections of relevant clinical documents (i.e., Investigator’s Brochure, etc.).
•   May provide support for aggregate reports (i.e., DSURs, etc.).
•   Provide support and back-up for Director, Drug Safety Operations

Requirements


Education and Qualifications

•   Health care professional (RN, PharmD, or equivalent) with minimum of 2 years of clinical or research experience or 3 years of relevant Drug Safety / Pharmacovigilance experience in the biotechnology / pharmaceutical industry with experience in both the pre-marketing and post-marketing pharmacovigilance.
•   Excellent knowledge of FDA, EU and ICH guidelines and regulations governing clinical trials and postmarketing safety including understanding of safety submission requirements
•   Knowledge of medical terminology and general principles of clinical assessment of AEs
•   Knowledge of MedDRA dictionary relevant to AE/SAE coding
•   Experience with software-based drug safety systems (ARGUS, ARISg, or equivalent)
•   Excellent communication skills, both written and verbal