About this role
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 Associate Directors, ICSR. 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. Strong experience in post marketing and clinical processing and staff management required.
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 Associate Directors and oversight of all employees to ensure they 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 applicableBusiness development activities Education, qualifications and professional memberships: Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance - Intermediate.
EXPERIENCE: Extensive experience in pharmacovigilance case processing including post marketing, clinical and ideally medical devices. Demonstrated leadership experience at a senior level.
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 workingPC SKILLS: Advanced literacy (MS Office) - Advanced:
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
Quality: we hold ourselves to the standard patients deserve.
Integrity and trust: we do the right thing, especially when it is hard.
Drive and passion: we care about the outcome, because someone is waiting on it.
Agility and responsiveness: we move quickly, because patients cannot wait.
Belonging: everyone is welcome, and every voice counts.
Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.