Senior Specialist, Pharmacovigilance Quality and Compliance

Remote Jobs; Brasil; Híbrido; USD 112.000 - 154.000; Tempo integral

Resumo da oferta

A global pharmaceutical company is looking for a Senior Specialist in Pharmacovigilance Quality and Compliance to support regulatory compliance and inspection readiness. This role offers the flexibility of hybrid or fully remote work. Ideal candidates will have a Bachelor's degree and at least 3 years of experience in pharmacovigilance. Competitive salary ranging from $112,000 to $154,000 based on experience.

Serviços

Competitive salary

Annual performance bonus

Comprehensive medical, dental, and vision coverage

401(k) retirement plan with company match

Generous parental leave

Opportunities for ongoing professional development

Qualificações

• Minimum 3+ years in PV operations or quality roles.
• Strong knowledge of U.S. and international PV regulations.
• Hands-on experience with safety databases.

Responsabilidades

• Support inspection and audit readiness.
• Investigate PV quality issues and monitor CAPAs.
• Maintain and update PV quality system documents.
• Contribute to the Pharmacovigilance System Master File.
• Assist in training coordination and compliance monitoring.

Conhecimentos

Pharmacovigilance operations

Regulatory compliance

Communication skills

Root cause analysis

Formação académica

Bachelor's degree in nursing, pharmacy, or healthcare field

Ferramentas

Safety databases (e.g., Argus)

Descrição da oferta de emprego

This position is posted by Jobgether on behalf of Deciphera Pharmaceuticals. We are currently looking for a Senior Specialist, Pharmacovigilance Quality and Compliance in Massachusetts (USA).

This opportunity is ideal for an experienced pharmacovigilance professional looking to advance quality and compliance standards within a highly regulated environment. You'll play a pivotal role in supporting inspection readiness, managing quality documentation, and ensuring regulatory compliance across global PV systems. The position offers a hybrid or fully remote setup, allowing for flexibility while remaining engaged in high-impact initiatives across clinical and post-marketing safety operations.

Accountabilities:

• Support inspection and audit readiness by coordinating materials, logistics, and documentation for internal and external reviews.
• Investigate PV quality issues, perform root cause analysis, and monitor CAPA implementation.
• Maintain and update PV quality system documents, including SOPs, WIs, and training records.
• Contribute to the development and maintenance of the Pharmacovigilance System Master File (PSMF).
• Manage PV agreements and track compliance with contractual obligations.
• Assist in training coordination, compliance monitoring, and maintenance of safety communication channels.
• Support vendor oversight, EU QPPV operations, and ensure accurate document control.
• Participate in cross-functional initiatives and strategic PV compliance projects.

Requirements

• Bachelor's degree in nursing, pharmacy, or a healthcare/life sciences-related field.
• Minimum 3+ years of experience in PV operations or quality roles within biotech, pharma, or healthcare.
• Strong knowledge of U.S. and international PV regulations (e.g., EU GVP, ICH, FDA).
• Experience with inspection and audit readiness, including addressing findings and implementing CAPAs.
• Hands-on experience with safety databases (e.g., Argus) and working with PV vendors.
• Excellent communication skills and the ability to collaborate across global, matrixed teams.
• Preferred: experience in PV training, SOP development, vendor oversight, and safety system migrations.

Benefits

• Competitive base salary ranging from $112,000 to $154,000, based on experience and location.
• Annual performance bonus and long-term incentive opportunities.
• Comprehensive medical, dental, and vision insurance coverage.
• 401(k) retirement plan with company match.
• Generous parental leave and family planning benefits.
• Opportunities for ongoing professional development in a collaborative and mission-driven environment.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.
It compares your profile to the job's core requirements and past success factors to determine your match score.
Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias - focusing solely on your fit for the role.
Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.

Thank you for your interest!

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