Deciphera Pharmaceuticals

Senior Specialist, Pharmacovigilance Quality and Compliance

WALTHAM, MAPosted 30+ days ago

Job summary

  • Job post source

    This job is directly from Deciphera Pharmaceuticals

  • Job overview

    The Senior Specialist, Pharmacovigilance Quality and Compliance at Deciphera Pharmaceuticals leads quality improvement in adverse event case management for clinical trials and post-marketing safety.

  • Responsibilities and impact

    The role involves supporting audit readiness, conducting investigations into quality issues, maintaining PV quality documentation, managing PV agreements, supporting training activities, vendor oversight, and contributing to strategic PV initiatives.

  • Compensation and benefits

    The position offers a competitive salary, annual bonus, comprehensive medical, dental, vision insurance, 401(k) with company match, generous parental leave, and family planning benefits.

  • Experience and skills

    Requires a bachelor's degree in nursing, pharmacy, or related field with 3+ years in PV operations or quality roles, knowledge of global PV regulations, experience with regulatory inspections, safety databases like Argus, and strong communication skills; preferred qualifications include training program development, vendor oversight, SOP development, and experience in global teams.

  • Career development

    The company offers outstanding culture and opportunities for personal and professional growth.

  • Work environment and culture

    Deciphera values diversity, equal employment opportunity, and fosters a supportive and inclusive work environment.

  • Company information

    Deciphera Pharmaceuticals is focused on improving cancer patient lives through innovative pharmaceutical development.

  • Job location and travel

    Remote or near the Waltham, MA office with potential for flexible work arrangements.

  • Application process

    Applicants are encouraged to apply online and complete an optional confidential diversity survey as part of the application process.

  • Unique job features

    The role includes leadership in PV quality and compliance with involvement in strategic initiatives and regulatory readiness, distinguishing it within pharmaceutical safety operations.

Company overview

Deciphera Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, and commercializing innovative medicines to improve the lives of cancer patients. They generate revenue primarily through the sale of their FDA-approved drug, QINLOCK, which treats gastrointestinal stromal tumors (GIST). Founded in 2003, Deciphera has a rich history of leveraging its proprietary kinase switch control inhibitor platform to create targeted therapies. The company is headquartered in Waltham, Massachusetts, and continues to advance its robust pipeline of drug candidates through clinical trials.

How to land this job

  • Tailor your resume to highlight your experience in pharmacovigilance quality and compliance, emphasizing your role in audit readiness, regulatory inspections, and quality system documentation management.

  • Focus on showcasing your knowledge of global PV regulations and your hands-on experience with safety databases like Argus, as well as your ability to collaborate cross-functionally and support vendor oversight.

  • Apply through multiple platforms including Deciphera Pharmaceuticals’ corporate careers page and LinkedIn to maximize your application visibility and reach.

  • Connect with current employees in the Pharmacovigilance or Quality Assurance divisions at Deciphera on LinkedIn; use ice breakers like commenting on recent company initiatives in PV compliance or asking about their experience with audit preparations to start conversations.

  • Optimize your resume for ATS by incorporating keywords from the job description such as 'pharmacovigilance,' 'audit readiness,' 'quality system documentation,' 'CAPA,' 'regulatory inspections,' and 'vendor oversight' to ensure it passes automated screenings.

  • Leverage Jennie Johnson’s Power Apply feature to automate tailored applications, identify multiple application channels, and find relevant LinkedIn contacts, allowing you to focus your energy on networking and interview preparation.

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