Manager, Pharmacovigilance Operations

The Consultant Manager, Pharmacovigilance (PV) operations collaborates very closely with the PV team and the cross functional teams to manage clinical trials and post-marketing case management and vendor oversight activities for contracted PV vendor(s).

The position requires an experienced and confident manager who can collaborate with multiple stakeholders internally and with the vendor(s) to ensure compliance and high-quality standards. The individual in this position must be able to manage multiple tasks at once and prioritize completing requests or projects.

This position will report to the Senior Manager/Manager, Pharmacovigilance.

• Key Responsibilities: Provide oversight of the PV operational and case management activities for safety reporting including the collection, processing, and reporting/submission of safety information for all products (investigational and commercial) including the review and monitoring of case quality and compliance through various monitoring reports and other oversight activities
• Escalate issues to management as needed
• Lead PV vendor management oversight activities including day-to-day oversight, review, and evaluation of the vendor performance and quality
• Generate performance and compliance metrics for the PV vendor and monitor for trends or possible improvements
• Lead and provide safety operations support on assigned studies
• Contribute to development and maintenance of Safety Data Exchange Agreements (SDEAs) and PV agreements with partners, vendors, and other third parties
• Support SAE reconciliation activities on assigned clinical studies
• Collaborate with study team members to develop documents related to safety case processing and reporting such as Safety Management Plan, Safety Reporting Forms and completion guidelines, reconciliation plan, data handling conventions
• Collaborate with internal teams to prepare for Regulatory Authority inspections and in relevant internal/external audits as subject matter expert on Pharmacovigilance operations
• Contribute to safety requests from Regulatory Authorities
• Participate in the development and maintenance of PV System policies, SOP forms, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices
• Review new or updated PV regulations for modifications to internal procedures or changes to the agreements with vendors or partners
• Collaborate with Medical Affairs, Commercial, or Marketing to develop processes, forms, and/or training to support Patient Support Programs, Market Research, and Investigator Initiated Studies
• Other responsibilities as assigned
• Required Qualifications: Bachelors/Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (MD, RN, PharmD, NP, PhD, MPH, etc.)
• Minimum of 5-7 years of direct pharmacovigilance experience
• Experience with safety databases (ARGUS, ARISg, or other safety database applications), electronic data capture (EDC) systems, and electronic document management systems.
• Knowledge of GCPs, ICH guidelines and FDA, EMA, and other international regulations and guidelines
• Working knowledge of MedDRA and WHO Drug dictionaries
• Experience with onboarding, overseeing and managing safety vendors
• ICSR submission experience is highly preferred
• Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment
• Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
• Proficient in standard computer software (Word, Excel and Power point presentations)
• Previous experience and formal training with safety database programs including configuration and validation activities is desired