The Specialist, Regulatory and PV Network (Delivery) is responsible for providing the strategy based on regulatory requirements and for completing 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 Specialist will also act as Local Contact Person for Pharmacovigilance for the designated country.
Job Responsibilities
Role and Responsibilities
- Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
- Provide intelligence on requirements and contribute to the development of the strategy and set up activities (Project Management Plan, joint operating procedures, POAs and core documents). Support identification of issues and corrective actions.
- 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.
- Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables.
- Provide Clients expertise and guidance at national level.
- Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS.
- Prepare client’s invoices and review/ approve vendors’ project invoices.
- Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.
- 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 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.
- Communicate suggestions for changes to departmental/company processes/procedures.
- May act as Local Contact Person for Pharmacovigilance or deputy