Offer summary

Qualifications:

Bachelor's degree in nursing, pharmacy, or life sciences preferred., Master’s or Doctorate level degree in a health care related profession is a plus., Experience with CROs and global pharmacovigilance operations is preferred., Strong analytical skills and knowledge of FDA and EU regulations are essential..

Key responsabilities:

Oversee external vendors and ensure compliance with safety monitoring and reporting activities.

Manage Drug Safety and Pharmacovigilance operations and review safety data across the portfolio.

Provide oversight of vendor timelines, budgets, and deliverables related to safety activities.

Collaborate with cross-functional teams to develop safety management plans and ensure inspection readiness.

Job description

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 Report Forms, 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
Global pharmacovigilance 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

Additional Qualifications

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

Required profile