PrimeVigilance is hiring a Senior Specialist, Regulatory & PV Network (Delivery). In this role, you will be responsible for developing regulatory strategy and driving key regulatory and pharmacovigilance deliverables. You will serve as a critical liaison between functions and act as the Local Contact Person for Pharmacovigilance for a designated country.
What You'll Do
- Assume leadership and functional representation for projects of medium/high complexity, ensuring effective coordination and management of regulatory deliverables.
- Develop strategy and manage set-up activities (Project Management Plan, joint operating procedures, POAs, core documents) with guidance from senior team members.
- Provide strategic input to internal and external customers, promptly identifying and addressing any risk or potential risk.
- Problem-solve and support the achievement of satisfactory resolution for performance issues or delivery failures.
- Collect, review, track, and maintain Local Contact Persons' CVs, job descriptions, training records, contact details, and monthly reports.
- Ensure correct training assignment and training compliance for the Local Contact Persons.
- Ensure all assigned team members are aware of tasks and timelines, monitor project budgets, and promptly identify and escalate any out-of-scope issues.
- Provide support for proposal development and budget input, and represent the department in business development meetings as required.
- Prepare client invoices and review/approve vendors' project invoices.
- Provide training, coaching, and mentoring to junior staff members.
- Foster professional working relationships with internal and external contacts at local and international levels.
- Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database.
- Participate in and/or support junior members in preparation for audits/inspections, providing department representation for assigned projects.
- Track Local Contact Persons' key performance indicators and prepare monthly summary reports.
- Provide feedback on vendor performance to aid in their assessment.
- Provide input to department/company initiatives and contribute to the design and review of SOPs, working practices, and guidance.
- Act as Local Contact Person for Pharmacovigilance or deputy.
PrimeVigilance is an equal opportunity employer.
