Senior Manager QPPV Office
New
J
JobgetherPharmacovigilance
Based remotely in IndiaFull-TimeManager
Salary not disclosed
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Job Details
- 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.
- Required Skills
- Process improvement
Requirements
- 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 global pharmacovigilance experience beyond individual case processing, including hands-on 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.
- Ability to collaborate across functions and international teams.
- Certification in pharmacovigilance or drug safety is preferred.
- Certifications in regulatory affairs, clinical safety, quality management, or auditing are advantageous.
Responsibilities
- Oversee and coordinate timely preparation of documentation relevant to health authorities and pharmacovigilance requirements.
- Act as process owner for Pharmacovigilance Agreement (PVA) management.
- Coordinate global pharmacovigilance activities related to PVA management.
- Develop and maintain standardised templates, project-specific documentation, and operational processes.
- Support continuous improvement and consistency of QPPV office procedures and documentation practices.
- Collaborate with cross-functional stakeholders on document preparation, review, coordination, and maintenance.
- Help ensure pharmacovigilance processes are organised, documented, and aligned with regulatory and quality expectations.
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