Senior Manager Pharmacovigilance Operations (4 months)

KPS Life; United States; Remote; USD 80,000 - 130,000; Full time

Job summary

An innovative firm is seeking a Senior Manager for Pharmacovigilance Operations. This role is crucial for ensuring compliance with safety monitoring and reporting standards. You will oversee vendor deliverables, manage budgets, and ensure high-quality data processing. Collaborating with cross-functional teams, you will facilitate safety planning and monitoring. The ideal candidate will possess strong analytical and communication skills and have a background in health care or life sciences. Join a dynamic team dedicated to improving patient safety and regulatory compliance in a fast-paced environment.

Qualifications

• Experience with CROs and vendor relationship management preferred.
• Knowledge of FDA and EU legislation and ICH Efficacy guidelines.

Responsibilities

• Oversees pharmacovigilance operations and vendor deliverables.
• Participates in sponsor oversight of adverse event processing.

Skills

Analytical Skills

Problem-Solving Skills

Communication Skills

Relationship Management

Education

Bachelor's degree in nursing, pharmacy, or life sciences

Master’s or Doctorate level degree in health care

Tools

Safety database (ARISg preferred)

MedDRA coding

Job description

Senior Manager Pharmacovigilance Operations (4 months)

Remote USA

Opportunity Details

On Assignment Senior Manager Pharmacovigilance Operations (4 months)

The Senior Manager, Pharmacovigilance Operations ensures oversight of external vendors and deliverables as determined necessary for pharmacovigilance, safety monitoring, and other required activities integral to safety surveillance, safety data reviews, case processing, and safety reporting to regulatory authorities, IRBs and other external stakeholders. The role ensures that performed tasks comply with SOPs, policies, best industry standards and applicable regulations.

Responsibilities

• Participates in the daily management and execution of Drug Safety and Pharmacovigilance operations
• Participates in sponsor oversight of Adverse Event/Serious adverse event processing by outsourced vendors, including the review of Individual Case Safety Report processing (case triage, data entry, coding review, sponsor approval and narrative writing)
• Reviews safety data across the portfolio
• Provides sponsor oversight of designated safety vendor timelines and deliverables
• Manages and oversees budgets/POs/contracts for vendors
• Provides input on study, vendor, and internal portfolio budgets for designated safety and reporting activities
• Ensures delegated responsibilities to safety related vendors overseen by this function follow applicable Safety Management Plan, SOPs, and regulations.
• Provides sponsor oversight of data reconciliations involving safety data and adverse events according to planned study milestones and timelines, including facilitation of vendor meetings as needed
• Monitors Quality of vendor’s Individual Case Safety Report processing, narratives, and outputs, collaborating with Medical Monitor(s), Clinical Operations and Clinical Development teams as applicable
• Monitors, supports and/or oversees the Intake of Adverse Event Reports from all sources for Individual Case Safety Reporting, cross-trial reporting and other regulatory reporting as required
• Liaison with other clinical functions for development of study documents and plans involving execution of safety planning and monitoring of study safety and data collection; including but not limited to: Safety Management Plans, safety Case ReportForms, and Statistical Analysis Plans directly related to Data Monitoring Committee Activities.
• In collaboration with other functions, responsible for oversight of aggregate reporting deliverables that may be outsourced for external development, such as DSURs, Investigational Brochures, and other reports as required
• Provides input and assessment in the quality management efforts for Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, and implementing continuous improvement actions and good documentation practices
• Works with internal and external QA, regulatory and TMF stakeholders to maintain a state of high PV inspection readiness for clinical studies in regions and countries where sponsored trials are taking place
• Develops internal SOPs, improve internal and external processes, identify process gaps and issues and collaborate with other functions to solve PV/safety/ocular related operational issues
• Works with biostats and DM to arrange for programmed safety data for periodic safety reviews such as IDMCs, safety surveillance, etc.
• Overall cross-functional facilitation of IDMC/DMC development, management and oversight of vendors involved
• Clinical trial posting management and oversight

Qualifications

• Bachelor's degree in nursing, pharmacy, or other health care related profession or life sciences preferred
• Master’s or Doctorate level degree in health care related profession preferred, but not essential
• Experience working with CROs, vendors, and relationship management preferred
• Globalpharmacovigilance operations experience with products in development
• Safety database (ARISg preferred), MedDRA coding and data entry experience
• Knowledge of FDA and EU legislation and ICH Efficacy guidelines
• Strong analytical and problem-solving skills with superb attention to detail
• Strong verbal, written technical communication and presentation skills
• Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization
• Proven ability to work within a cross-functional, matrixed team