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Sr. Associate/Medical Operations (Oncology preferred) - As14020

TechData Service Company LLC San Diego ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Company: Large Pharmaceutical Company

Title:  Sr. Associate / Medical Operations

Contract Position: Until 12/31/2020 with potential contract extension

Description:

Objective of Position

This position encompasses a key role in executing departmental strategy for individual case safety report (ICSR), study, post-approval safety, and systems and information management, as well as supporting the overall Medical Safety (MS) group. This role collaborates with colleagues and vendors including MS Science, MS Excellence, Clinical Science, Clinical Operations, Biometrics, Regulatory Science (RS), Quality Assurance (QA), and Legal. Essential Duties/Responsibilities • Performs internal activities and oversight of outsourced activities for ICSR processing and reporting from all sources in compliance and quality according to company procedures and regulatory requirements • Ensures that expedited and periodic safety reports to regulatory authorities and license partners are submitted and compliance is tracked • Liaises with assigned Clinical Reviewer to ensure that appropriate review and assessment is provided for ICSRs • Performs safety data extraction and production from MS systems for internal partners and regulatory submissions • Performs receipt and submission reconciliation between license partners and vendors and serious adverse event (SAE) reconciliation between the clinical and safety databases • Collaborates with QA on product complaints associated with ICSRs • Ensures clinical study management team representation and support • Supports regulatory authority interactions (both written and verbal), inspections, and audits

 

Requirements

• Minimum 3 years of drug safety, clinical research, or healthcare-related experience preferred; oncology experience highly desired • Minimum 2 years direct pharmaceutical industry experience dealing with global clinical study safety processing and reporting preferred; global post-approval safety experience highly desired • Detailed knowledge of relevant US, EU and ICH guidelines, initiatives, and regulations governing both clinical studies and post-approval safety

 

Education/Training

• Bachelor's degree in life sciences, MD, PhD, PharmD, BSN/RN preferred • Safety database experience required • Proficient in MS Word, Excel, PowerPoint, Outlook, and other applicable business software tools Job Description CONFIDENTIAL INFORMATION Page 2 of 2 Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. This document may be changed at management’s discretion. Acerta Pharma is an equal opportunity employer. Acerta Pharma will consider all qualified applicants for employment

TechData Service Company LLC

Address

121 Oyster Point Blvd
San Diego, CA
USA

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