ICSR Operational Lead

1 week ago

Raleigh, North Carolina, United States PrimeVigilance Full time

Company Description
We are PrimeVigilance (part of Ergomed PLC), 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.

Job Description
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 LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (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)

Additional Information

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. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

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

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join

  • Quality
  • Integrity & Trust
  • Drive & Passion
  • Agility & Responsiveness
  • Belonging
  • Collaborative Partnerships

We look forward to welcoming your application.

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