Job Description

Company Description

PrimeVigilance, an company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders and leaders have an unrivalled reputation in the sector with a network of expert associates across the world.



POSITION SUMMARY

• Manages and mentors Team Leaders for assigned projects
• Leads the team responsible for ICSR management for a selected project or group of projects as ICSR team lead
• Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process
• Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management
• Contributes to achieving companys goals and objectives
• Works independently

KEY RESPONSIBILITIES

• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
• Performing ICSR follow up
• AE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
• Reconciliation (clinical, partners)
• Personal data protection
• Product Quality Complaint handling and interaction with Quality Assurance
• Medical Information interaction
• MedDRA and WHO coding
• Database Outputs and Reports (including data for monthly reporting to clients)
• Workflow & resource management
• Line Management tasks (periodic appraisals, performing vacation approval, ensuring adequate cover is in place to meet operational requirements for existing and new contracts)
• Mentoring and training of new and more junior employees within the department
• Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
• More senior colleague may perform tasks assigned as per SOP to more junior position
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe

Case Processing Manager responsibilities:

• Leads the team responsible for ICSR management for a selected project or group of projects as Case Processing Manager:
• Following are Case Processing Manager responsibilities (including, but not limited to):
• Leadership and expert advice in the area of ICSR management
• Line management of the assigned team and subordinated colleagues
• Training and development of skills
• Ongoing and periodic appraisal
• Equal distribution of workload
• Coordination of activities with Team Leads and other Case Processing Managers, where applicable
• Project team members allocation based on times spent on ICSR management activities for the given projects, resource management and ICSR workflow management
• Supervise, train and develop colleagues in the team, as well as provide training to other PrimeVigilance's employees and clients
• Support in authoring/development of quality documents in the area of ICSR Management Unit
• Monitoring and analysing activities entered in ActiTIME by employees within assigned project teams
• Monitoring the regular entry of data in ActiTIME and, if necessary, requesting entry of incomplete data
• Monitoring team utilisation for ongoing projects and proposing productivity target updates to ICSR Operational Lead based on ActiTIME data analysis
• With regard to the analysis of data from ActiTIME for assigned project teams and in coordination with other Case Processing Managers, propose temporary or permanent allocation of resources to ICSR Operational Lead, all with the aim of maintaining a high level of productivity and utilization
• Supporting other Case Processing Mangers, ICSR Operational Leads and ICSR Functional Head for requests related to assigned project and team
• Providing team assignments for new projects or increased scope of work for existing projects, when requested by Directors of Projects or ICSR Operational Leads
• Reviewing and approving of all Minor CAPAs from assigned project teams
• Reviewing and addressing any requests from Quality department regarding assigned project teams

Qualifications

Education

Educated to degree standard or appropriate work experience

Experience

Extensive Pharmacovigilance experience including leading a team.

Special Skills

• Excellent communication (written and verbal) skills
• Organization skills, including attention to details and multitasking
• Delegation skills
• Planning and time management
• Technical skills
• Team working

Additional Information

Why Should You Apply?

• You want be involved in a wide range of interesting projects and studies
• You'd like your achievements and hard work to be recognized
• You want to work for a growing company where there are opportunities for advancement
• You'd like to work in a company that has a great reputation with its clients and employees.
• Making a difference to people's lives matters to you