Full-Time Senior Specialist, Pharmacovigilance

The Senior Specialist, Regulatory and PV Network is responsible for developing the strategy based on regulatory requirements and for driving regulatory and PV deliverables.

They 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.

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 coordination and management of regulatory deliverables.
• Develop strategy and manage setup 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 tasks and allocated time, monitor budgets, track hours, and identify/escalate any issues.
• Support proposal development and input to budgets, represent the department in BD meetings.
• Prepare client invoices and review/approve vendor invoices.
• Provide training, coaching, and mentoring to junior staff.
• Foster professional relationships with internal and external contacts.
• Stay abreast of regulatory changes and maintain the regulatory intelligence database.
• Participate in and support audits/inspections, provide department representation for assigned projects.
• Track LCPs' key performance indicators and prepare monthly reports.
• Provide feedback on vendor performance.
• Contribute to department/company initiatives and design/review SOPs/working practices/guidance.

Qualifications

• Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience.
• Strong experience within the 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 (written and verbal).
• Proficient in the official language of the designated country.
• Proficiency in German, French, or Italian is a plus.

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