Director of ICSR- Pharmacovigilance (North America)

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. 

POSITION SUMMARY: Manages ICSR Management Unit for assigned staff and ensures all unit-relevant activities are delivered within agreed extent. Contributes to achieving company´s goals and objectives. Performs project budget reviews, and provides support to, and management of, the ICSR leads. Other responsibilities include independent analysis of workload, productivity and utilization of resources and their appropriate redistribution to ensure performance of the highest quality as well as coordination with other departments for all activities related to the ICSR Management Unit. Must have strong case processing and staff management experience.

Role and Responsibilities

• 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

Education, qualifications and professional memberships: Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance - Intermediate.

EXPERIENCE: Minimum 7-9+ years of work experience in pharmacovigilance within which 5-7+ years of work experience in line manager role - Advanced.

SPECIAL SKILLS (Advanced): 

• 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

LANGUAGE SKILLS: English – fluent (spoken, written) -  Full Professional;

PC SKILLS: Advanced literacy (MS Office) - Advanced:

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. 

Our Offer

• Competitive salary
• Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
• Multicultural environment, English as a company language
• Strong emphasis on personal and professional growth
• Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
• Friendly working environment with several social events per year

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.