ICSR Operational Lead

Ergomed • Raleigh, NC

9d

About The Position

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.
We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
Role and Responsibilities
Line Manages assigned Team Leads and supports their teams
Ensures effective Line Management in assigned teams (up to 15 direct reports/Team Lead)
Reviews project resourcing and ensures proactive assignment to avoid/minimize backlogs
Supports Contracts 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 (Associate) Director of ICSR
Works independently, with support from (Associate) Director of ICSR

Requirements

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
• Minimum 5 years of work experience in pharmacovigilance ICSR processing 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
• Team working
• English – fluent (spoken, written)
• Advanced literacy (MS Office)

Responsibilities

• Line Manages assigned Team Leads and supports their teams
• Ensures effective Line Management in assigned teams (up to 15 direct reports/Team Lead)
• Reviews project resourcing and ensures proactive assignment to avoid/minimize backlogs
• Supports Contracts 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 (Associate) Director of ICSR
• Works independently, with support from (Associate) Director of ICSR

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager