Senior Manager QPPV Office

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

• Abachelor’s degreein life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related discipline, or equivalent experience.

• At least4 years of experiencein pharmacovigilance, drug safety, epidemiology, risk management, scientific consulting, regulatory affairs, or a related field.

• At least2 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.