Full-Time Senior Specialist Pharmacovigilance

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.

Responsibilities:

• Act as Local Contact Person for Pharmacovigilance for the designated country
• Assume leadership and functional representation for projects ensuring effective coordination and management of regulatory deliverables, driving the team to meet targets and comply with procedures, trackers, and templates
• Develop strategy and manage set up activities (Project Management Plan, joint operating procedures, POAs, and core documents) with the help of a senior team member
• Provide strategic input to internal and external customers, identify and address risks/potential risks
• Problem solve and support 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 and training compliance by LCPs
• Ensure team members are aware of project tasks and allocated time; monitor project budgets, hours spent vs. budgeted, and identify/escalate any issues
• Provide support to proposal development and input to budgets; provide department representation to BD meetings
• Prepare client invoices and review/approve vendors' project invoices
• Provide training, coaching, and mentoring to junior staff
• Foster professional working relationships to ensure smooth service delivery
• Stay abreast of changing regulatory requirements and maintain regulatory intelligence database, disseminating pertinent changes
• Participate in/support junior members in preparation for audits/inspections and provide department representation for assigned projects
• Track LCPs' key performance indicators and prepare monthly summary reports
• Provide feedback on vendor performance
• Provide input to department/company initiatives and contribute to the design/review of SOPs/working practices/guidance

Qualifications:

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent experience
• Minimum 3 years within pharmaceutical or CRO industry or Regulatory body
• Good knowledge of ICH GCP and/or GVP and national regulations
• PV training and/or working experience
• Fluent in English, both written and verbal
• Proficient in the official language of the country
• Proficiency in German, French, or Italian is a plus

What is the last date for applying to the job?

Which countries are accepted for this remote job?