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Raleigh, United States Remote (Global) Employment

Ergomed is hiring a PV Project Director

Responsibilities

  • Lead and mentor a team of Project Managers to ensure effective project delivery.
  • Ensure all contracted pharmacovigilance activities are completed on time, within budget, and to high quality standards while meeting regulatory requirements.
  • Serve as a pharmacovigilance subject matter expert to support project teams on client engagements as needed.
  • Assist Business Unit Leads, department leadership, and senior management with client-related initiatives as required.
  • Represent both client and organizational interests through direct reporting to maintain agreed project scope.
  • Monitor and manage changes to project scope, timelines, and budgets as necessary.
  • Foster strong client relationships and consistently deliver high-quality services.
  • Participate in issue escalation processes when required.
  • Interpret client pharmacovigilance needs and ensure services fully meet those requirements.
  • Supervise planning for project setup and ongoing maintenance activities, including attendance at client meetings when needed.
  • Maintain awareness of all client deliverables and their status.
  • Engage in client deliverable tasks as appropriate.
  • Oversee all client communications related to issues and concerns.
  • Manage training programs for project teams to ensure competence and compliance.
  • Collaborate closely with internal departments and client counterparts to ensure timely, high-quality service delivery.
  • Ensure all relevant teams and personnel understand the client’s project scope and expectations.
  • Review client-specific operational documents such as safety management plans and joint guidelines as applicable.
  • Ensure timely preparation and submission of client invoices.
  • Evaluate project-specific data and reports as required.
  • Provide clients with expert advice on pharmacovigilance matters, including regulatory updates and guidance changes.
  • Ensure qualified personnel are assigned to manage and support client projects effectively.
  • Oversee Quality Management System activities related to client projects as needed.
  • Ensure adherence to client-specific quality standards and procedures.
  • Maintain compliance with global pharmacovigilance regulations, manage Quality Events, and implement corrective and preventive actions.
  • Participate in client-led audits and regulatory inspections.
About company
Ergomed
PrimeVigilance (part of Ergomed Group), is 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: Main responsibilities:* 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. * Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes. * Provide regulatory 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. * Ensure compliance with company procedures, processes, training records, systems and any other tools * 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. * 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. * Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required. * 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. * May also be required to line manager. Qualifications: * Degree in Chemistry or Life Sciences, Nursing or equivalent experience. * Strong previous experience within pharmaceutical or CRO industry or Regulatory body * Previous Project Management experience is desirable * Knowledge of Pharmacovigilance/Regulatory field * Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency. * Fluent Proficiency in English, both written and verbal. Additional languages are desirable. * Strong organization skills and detailed orientated approach to work Additional Information: Why PrimeVigilanceWe 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. We offer: * 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 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. #LI remote
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Job Details
Department Project Management
Category management
Posted 3 months ago