About this opportunity
PrimeVigilance lists this Associate Director. ICSR opportunity in raleigh, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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 patients' lives.
Job Description
Managing the assigned ICSR Management Unit effectively
Ensuring adequate resources within the ICSR project teams to achieve the maximum level of productivity and utilisation
Setting productivity targets for ongoing projects and reviewing proposed target updates as required
Based on reports and analyses, defining the appropriate reallocation of resources in ICSR Management Unit, or working with the resourcing unit for reallocation to and from other units and departments
Managing ICSR Leads/Line Managers to ensure all employees are adequately utilised and productive and reallocating employees to other ICSR Leads/teams as necessary
Notifying the Resourcing department about the need for additional resources for assigned project teams if resources cannot be managed internally and officially opening the requests upon approval and budget confirmations
Proposing the necessary changes within the project team processes to ICSR leadership
Finding solutions and introducing best practices to increase productivity and utilization within the ICSR Management Unit
Training and mentoring of ICSR Line Managers and senior staff.
Preparing various analyses and reports
Reviewing budgets and resource allocations for all new projects and new scope of work for existing projects and supporting Directors of Projects, as applicable
Supporting the Business/Commercial team during development of contracts and proposals, as applicable
Supporting the Operations and Project Analytics team, as applicable
Assisting HR in employee recruitment, performance evaluation, promotion, retention and termination activities
Reviewing and approving all Critical CAPAs from the ICSR Management Unit
Reviewing and addressing any requests from Quality department regarding ICSR Management Unit
Reviewing and updating PrimeVigilance operating procedures and guidelines, as applicable
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
We expect:
Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
6-7 years of work experience in pharmacovigilance within which 2-3 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)
Additional Information
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.
#J-18808-Ljbffr
Worksite address
raleigh, NC, 27601, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.