Senior Manager QPPV Office

Job description

**This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Manager QPPV Office based remotely in India.** We are seeking an experienced pharmacovigilance professional to support the oversight and coordination of Qualified Person Responsible for Pharmacovigilance (QPPV) office activities. In this role, you will help ensure the timely preparation of authority-relevant documentation and maintain effective processes for Pharmacovigilance Agreements (PVAs). You will contribute to the development of standardised templates, project-specific documents, and robust operational procedures that support regulatory compliance and quality. Working at the intersection of drug safety, regulatory affairs, and process governance, you will collaborate with relevant stakeholders to maintain consistency and efficiency across global pharmacovigilance activities. This opportunity is suited to a detail-oriented professional with strong coordination skills, sound regulatory knowledge, and a commitment to patient safety. Your work will help strengthen pharmacovigilance oversight and support the safe use of medicines across international markets. ### Accountabilities - Oversee and coordinate the timely preparation of documentation relevant to health authorities and pharmacovigilance requirements. - Act as the process owner for Pharmacovigilance Agreement (PVA) management, supporting consistent and effective agreement-related processes. - Coordinate global pharmacovigilance activities related to PVA management, ensuring appropriate oversight and alignment with applicable requirements. - Conceptualise, develop, and maintain standardised templates, project-specific documentation, and operational processes. - Support the continuous improvement and consistency of QPPV office procedures and documentation practices. - Collaborate with cross-functional stakeholders to facilitate the preparation, review, coordination, and maintenance of relevant documents. - Help ensure that pharmacovigilance processes are organised, well documented, and aligned with applicable regulatory and quality expectations. ## Requirements - A **bachelor’s degree** in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related discipline, or equivalent experience. - At least **4 years of experience** in pharmacovigilance, drug safety, epidemiology, risk management, scientific consulting, regulatory affairs, or a related field. - At least **2 years of experience in global pharmacovigilance**, specifically beyond individual case processing, including hands-on experience with Pharmacovigilance Agreement (PVA) management. - Demonstrated understanding of global pharmacovigilance processes and documentation requirements. - Experience coordinating regulatory or authority-relevant documents and developing templates, procedures, and project-specific documentation. - Strong organisational skills and attention to detail, with the ability to coordinate multiple activities and meet deadlines. - Effective communication and stakeholder-management skills, including the ability to collaborate across functions and international teams. - A proactive approach to process ownership, documentation quality, and continuous improvement. - Certification in pharmacovigilance or drug safety is preferred. - Certifications in regulatory affairs, clinical safety, quality management, or auditing are also advantageous. ## Benefits - **Employment type:** Full-time. - **Work arrangement:** Remote opportunity in India. - **Location flexibility:** The original listing also identifies locations in Bulgaria, Portugal, and Spain; eligibility for remote work from India should be confirmed during the recruitment process. - **Compensation:** Salary details were not specified in the job description. - **Additional benefits:** Healthcare coverage, paid leave, retirement benefits, and other perks were not detailed. Benefits may vary by country and local employment practices, so the available package should be confirmed during the hiring process.