Senior Manager, Pharmacovigilance Operations - Remote

Overview

The Senior Manager, Pharmacovigilance Operations encompasses a key leadership role in providing direction to the Pharmacovigilance department for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance for all Deciphera Pharmaceuticals Clinical Trials and post marketing (where applicable).

In Short

• Responsible for performing critical safety vendor oversight to ensure all pharmacovigilance activities are performed in an efficient, consistent and compliant manner.
• Accountable for coordination of day-to-day operational ICSR activities in collaboration with designated management personnel at the vendor site(s).
• Provide oversight and review of vendor case processing and submission activities by external vendor.
• Responsible for facilitation of training, including training GVP Modules and key relevant US & EMA safety-related Guidance documents.
• Lead Deciphera Pharmaceuticals PV Operations in ensuring all safety reports received from all clinical trials are processed in a consistent and compliant manner.
• Oversee maintenance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events.
• Provide direct technical/data management support to ensure information entered and retrieved from the safety database is consistent, accurate and complete.
• Support the oversight and management of global business partner safety data exchange agreements.
• Develop and maintain Medical Safety and Pharmacovigilance related documents.
• Work cross functionally with Regulatory Affairs and Quality Assurance functions.

Requirements

• Bachelors/Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession.
• 6+ years of direct pharmacovigilance work experience in the pharmaceutical industry.
• Experience with Argus Safety database is a must.
• Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements.
• ICSR submission experience is highly preferred.
• Knowledge of MedDRA and WHO Drug dictionaries.
• Experience with overseeing and managing vendors.
• Strong proficiency in verbal and written communication.
• Ability to work independently and manage work priorities.
• Proficient in standard computer software (Word, Excel, PowerPoint).

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.