Associate Director. ICSR

Location: Raleigh, NC, us, Remote

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

• 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.