Manager, Pharmacovigilance Operations

Company Description

Position Summary:
The Manager, Pharmacovigilance Operations will oversee pharmacovigilance activities and vendor management for contracted PV vendors. This role requires an experienced manager capable of collaborating with multiple stakeholders to ensure compliance and high-quality standards. The individual must manage multiple tasks and prioritize projects effectively.

Job Description

Key Responsibilities:

• Oversee PV operational and case management activities for safety data processing and reporting.
• Lead PV vendor management and performance and quality evaluation.
• Generate and monitor performance metrics for PV vendors.
• Participate in the development and maintenance of PV procedures such as SOP forms, and guidance documents
• Manage SAE/SUSAR reporting activities for investigational drugs.
• Collaborate with cross-functional teams to develop safety-related documents.
• Support SAE reconciliation activities and contribute to safety sections of regulatory documents.
• Assist in the preparation and updates of Investigator Brochures, DSURs, Protocols, etc.
• Contribute to development of PV infrastructure, new safety projects and safety systems.
• Prepare for Regulatory Authority inspections and audits.
• Contribute to development and maintenance of Safety Data Exchange Agreements and PV agreements.
• Support signal management activities and aggregate safety reports.

Qualifications

Required Qualifications:

• Bachelor's/Advanced degree in life sciences, nursing, pharmacy, or related healthcare profession.
• 5+ years of medical, scientific, and pharmacovigilance experience.
• Experience with Argus safety databases, EDC systems, and electronic document management systems.
• Knowledge of GCPs, GVPs, ICH guidelines, and international regulations.
• Proficiency in MedDRA and WHO Drug dictionaries.
• Strong interpersonal and communication skills.
• Detail-oriented with good organizational and time management skills.
• Proficient in standard computer software (Word, Excel, PowerPoint).

Additional Information

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $122,000.00 - $168,000.00. 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 Deciphera’s 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 and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a 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.  Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.