Logo
PrimeVigilance

ICSR Operational Lead

PrimeVigilance, Raleigh, North Carolina, United States, 27601

Save Job

Overview

PrimeVigilance (part of Ergomed PLC) is a specialised mid-size pharmacovigilance service provider established in 2008. We cover Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance across Europe, North America and Asia. Role and Responsibilities

Resolves assignments from Board, President, SDMD Head and Director of ICSR Line Manages assigned Team Leads and supports their teams Ensures effective Line Management in assigned teams (up to 15 direct reports/line manager) Reviews project resourcing and ensures proactive assignment to avoid/minimize backlogs Supports Business Development and Proposals with any existing and new opportunities Supports Team leads with deviation management Reviews and approves all minor and major CAPAs from the ICSR Management Unit Supports other departments, as agreed with Director of ICSR Works independently, with support from Director of ICSR Supporting the RA & PV Network Department as needed, including acting as the Local Contact Person for Pharmacovigilance for the specified country and taking on the role of Person Responsible for Local Screening for the designated language, as agreed with the line manager Qualifications

Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance Minimum 5 years of work experience in pharmacovigilance within which minimum 2 years of work experience in line manager role Excellent communication (written and verbal) skills Excellent organization skills, including attention to details and multitasking Excellent management skills, including delegation skills, time and issue management Technical skills Team working English – fluent (spoken, written) Advanced literacy (MS Office) Why PrimeVigilance

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. We Offer

Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Seniority level

Mid-Senior level Employment type

Full-time Job function

Management and Manufacturing Industries

Pharmaceutical Manufacturing

#J-18808-Ljbffr