ERGOMED

Principal/Senior Pharmacovigilance Project Manager

ERGOMED

full-time

Posted on:

Location Type: Remote

Location: Bulgaria

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Job Level

Senior

About the role

  • Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget, and are on time with good quality and in compliance with the applicable regulatory requirements
  • Providing support to Director of Projects and senior leadership management, as applicable, in other activities undertaken on behalf of the client and the company
  • Acting as the primary contact point for project-related matters
  • Workflow management, KPI/metric reporting
  • Manage changes to the project scope, project schedule and project costs, as applicable
  • Maintaining good client relations and ensuring a consistently high quality of work for each client
  • Understand client PV requirements and ensure service provided addresses all requirements
  • Project set-up and maintenance activities planning; Organising/chairing and attending regular client meetings
  • Having an overview of all tasks to be delivered to the client, including deadlines and interim milestones
  • Assurance of training of all team members from relevant quality documents, including project-specific documentation
  • Close cooperation with other Primevigilance and/or the client’s respective departments making sure contracted activities are delivered with high quality and within set timelines
  • Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope
  • Preparation of client specific core documents (e.g. Join operational guidelines, Safety management plan, Monthly reports, etc), as applicable
  • Preparation of invoices, project financial analysis
  • Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance
  • Managing Quality Management System activities for the client; development of standard operating procedures and operational guidelines, maintaining compliance with the PV system and providing PV training, as required

Requirements

  • Proven track record of demonstrated Pharmacovigilance activities including processing and quality review of ICSRs
  • Writing, or contributing to aggregate reports, literature screening, reconciliation, and preparation of SOPs
  • PV Project Management experience from ideally a service provider / CRO
  • Health Care Professional or Life Science Graduate
  • Be comfortable with communicating at senior levels within pharmaceutical organizations
  • Have good leadership qualities including skills in planning, mentoring, meeting facilitation, communication and problem solving
Benefits
  • 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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
PharmacovigilanceICSR processingquality reviewaggregate reports writingliterature screeningSOP preparationproject managementfinancial analysisquality management systemstandard operating procedures development
Soft skills
leadershipplanningmentoringmeeting facilitationcommunicationproblem solvingclient relationsworkflow managementKPI reportingteam training
Certifications
Health Care ProfessionalLife Science Graduate