Ergomed
pharmacovigilance
SeniorSpecialist,Regulatory&PVNetwork
“Senior Specialist, Regulatory & PV Network at Ergomed. Skills: Regulatory Affairs, Pharmacovigilance, Regulatory Strategy, PV Network Management. developing the strategy based on regulatory requirements. driving regulatory and PV deliverables based on an established PV and regulatory plan”
What You'll Achieve.
driving the team to meet the agreed targets; comply with the agreed procedures, trackers and templates; achievement of satisfactory resolution of performance issues or delivery failures; timely dissemination of pertinent changes
Industry & Context.
Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures; promptly identify and address any risk/potential risk by implementing preventive measures
Act as Local Contact Person for Pharmacovigilance for the designated country
What They're Looking For.
Must Have
Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience, experience within pharmaceutical or CRO industry or Regulatory body, Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency, PV training and/or working experience and other educational or professional background as required locally, Fluent in English, both written and verbal, Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance
Nice to Have
Proficiency in German, French, or Italian is a plus but not mandatory
What You'll Do.
developing the strategy based on regulatory requirements
driving regulatory and PV deliverables based on an established PV and regulatory plan
serving as a liaison between regulatory and other functional areas including external partners
authorities and/or consultants in the planning
and preparing of regulatory deliverables following project
corporate and industry regulatory strategies
acting 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
track and maintain LCPs' CVs
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
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
How You'll Work.
Team & Collaboration
serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants; Foster professional working relationships with internal and external contacts at the local and international levels; collaborate with colleagues based all over the world
Communication Scope
Fluent in English, both written and verbal; proficient in the official language of the country in which they are based
Process & Methodology
Project Management Plan, coordination and management of regulatory deliverables, monitor project budgets, hours spent vs budgeted
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