Belgrade, Serbia
40 days ago
Associate Director of ICSR (Europe)

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

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.

Role and Responsibilities:

Managing the assigned ICSR Management Unit effectivelyEnsuring adequate resources within the ICSR project teams to achieve the maximum level of productivity and utilisationSetting productivity targets for ongoing projects and reviewing proposed target updates as requiredBased 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 departmentsManaging ICSR Leads/Line Managers to ensure all employees are adequately utilised and productive and reallocating employees to other ICSR Leads/teams as necessaryNotifying 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 confirmationsProposing the necessary changes within the project team processes to ICSR leadershipFinding solutions and introducing best practices to increase productivity and utilization within the ICSR Management UnitTraining and mentoring of ICSR Line Managers and senior staff.Preparing various analyses and reportsReviewing budgets and resource allocations for all new projects and new scope of work for existing projects and supporting Directors of Projects, as applicableSupporting the Business/Commercial team during development of contracts and proposals, as applicableSupporting the Operations and Project Analytics team, as applicableAssisting HR in employee recruitment, performance evaluation, promotion, retention and termination activitiesReviewing and approving all Critical CAPAs from the ICSR Management UnitReviewing and addressing any requests from Quality department regarding ICSR Management UnitReviewing and updating PrimeVigilance operating procedures and guidelines, as applicableSupporting 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

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

EXPERIENCE: 6-7 years of work experience in pharmacovigilance within which 2-3 years of work experience in line manager role - Advanced.

SPECIAL SKILLS (Advanced): 

Excellent communication (written and verbal) skillsExcellent organization skills, including attention to details and multitaskingExcellent management skills, including delegation skills, time and issue managementTechnical skillsTeam working

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

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

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. 

Our Offer

Competitive salaryDynamic team of colleagues in a fast-growing company – possibility for your quick career growthMulticultural environment, English as a company languageStrong emphasis on personal and professional growthExtensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroadFriendly 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. 

 

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