Manager, Pharmacovigilance Operations
Manager, Pharmacovigilance Operations
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Salary Not Disclosed
1 Vacancy
Job Description
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.
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 :
- Bachelors/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 $122000.00 - $168000.00. 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 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 :
No
Employment Type :
Full-time
Employment Type
Full-time
