Senior Specialist, Pharmacovigilance Quality and Compliance
Senior Specialist, Pharmacovigilance Quality and Compliance
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Salary Not Disclosed
1 Vacancy
Job Description
The Senior Specialist Pharmacovigilance (PV) Quality and Compliance encompasses a key role in providing direction to the PV department and promote the spirit of proactive continuous quality improvement in adverse event case management for all Deciphera Pharmaceuticals Clinical Trials Extended Access Programs and post marketing (where applicable).
This position will report to the Senior Manager Pharmacovigilance (PV) Quality and Compliance and be remote or near the Waltham MA office.
Key Responsibilities:
- Support the preparation and readiness of the pharmacovigilance (PV) system for internal audits and external regulatory inspections.
- Assist in conducting investigations into PV quality issues and ensure proper documentation of root cause analyses and CAPA implementation.
- Collaborate with QA and PV teams to support audit/inspection activities including coordination of inspection readiness materials and logistics.
- Maintain key PV quality system documentation such as SOPs work instructions (WIs) and training records ensuring updates are performed in a timely manner.
- Contribute to the creation and review of the Pharmacovigilance System Master File (PSMF) and associated documentation to ensure compliance with global regulatory requirements.
- Coordinate the review and management of PV agreements (PVAs) and track team compliance with obligations outlined in the agreements.
- Support the execution of PV training activities including maintenance of training records training matrices and compliance tracking for mandatory PV training.
- Collaborate with internal stakeholders to support effective document control record retention and access to PV-related quality documents.
- Assist in managing vendor and business partner oversight by supporting audit follow-ups tracking CAPA implementation and ensuring appropriate documentation.
- Provide operational support to the EU QPPV office and contribute to the maintenance of quality-related deliverables.
- Help monitor and maintain safety operations communication channels (e.g. distribution lists and mailboxes) to ensure timely response and triage.
- Contributes to strategic initiatives across PV as required.
Qualifications :
What Youll Bring:
- Bachelors degree in nursing pharmacy or a healthcare/life sciences-related field.
- Minimum of 3 years of experience in Pharmacovigilance (PV) operations and/or quality roles within the pharmaceutical biotech or healthcare industry.
- Experience supporting or participating in regulatory inspection and audit readiness activities including involvement in addressing audit and inspection findings.
- Working knowledge of U.S. and global PV regulations guidelines and compliance (e.g. U.S. CFR EU GVP ICH).
- Experience working with contract service providers in PV functions such as case processing aggregate reporting and quality management.
- Familiarity with regulatory inspections and audits including MHRA and/or EMA PV inspections.
- Hands-on experience with safety databases (e.g. Argus) for case management and regulatory reporting.
- Strong interpersonal and communication skills with the ability to work independently and collaboratively in cross-functional teams.
Preferred Qualifications:
- Experience supporting the development delivery and effectiveness monitoring of PV compliance training programs.
- Exposure to vendor oversight including performance monitoring and quality assurance of outsourced PV services.
- Familiarity with standard operating procedure (SOP) development and continuous process improvement within PV operations or quality functions.
- Experience contributing to PV system or safety database upgrades/migrations.
- Experience working in a global or matrixed team environment.
Additional Information :
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $112000 - $154000. Actual compensation packages will depend on various factors including but not limited to depth of experience education skillset overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Decipheras competitive total rewards strategy that also includes annual performance bonus a long-term incentive plan full range of benefits and other incentive compensation plans (if applicable)
Benefits:
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical dental vision insurance 401(k) retirement plan with company match and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
