Senior Specialist, Regulatory

3 days ago

Prague, Hlavní město Praha, Czech Republic Ergomed Full time €60,000 - €80,000 per year

The Senior Specialist, Regulatory and PV Network is responsible for developing the strategy based on regulatory requirements and for driving regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies.

The Senior Specialist will also act as Local Contact Person for Pharmacovigilance for the designated country.

Job Responsibilities

  • Act as Local Contact Person for Pharmacovigilance for the designated country
  • Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates
  • With the help of a senior member of the team, develop strategy and manage set up activities (Project Management Plan, joint operating procedures, POAs and core documents)
  • Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures
  • Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
  • Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports
  • Ensure correct training assignment to and training compliance by the LCPs
  • Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS
  • Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
  • Prepare client's invoices and review/approve vendors' project invoices
  • Provide training, coaching and mentoring to junior members of staff
  • Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
  • Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
  • Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required
  • Track LCPs' key performance indicators and prepare monthly summary reports
  • Provide feedback on performance of vendors to aid their assessment
  • Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.

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