Senior PV Operations Specialist
About the position
The core mission of the Verastem Safety & Pharmacovigilance group is to ensure patient safety for all patient’s receiving Verastem manufactured products. This is done by ensuring that the safety profile of Verastem products remains accurate and up to date throughout the product life cycle of development and through the following core activities:
Relevant safety information including reports of side effects is collected and analyzed.
Possible safety signals are carefully validated and characterized.
Strategies are implemented to minimize risks and to ensure that products are used in a way that maximizes benefits and minimizes risks. Key among these is to ensure that accurate and up-to-date information on the safety profile of Verastem products is available to patients and prescribers in a timely manner. Communication with patients, providers, regulatory agencies, and other concerned bodies is essential to this effort. This includes developing and updating the investigator brochure, and protocols as well as any adjunct information for patients and health professionals. This information must be kept current throughout the life cycle of each product.
Reporting to the Vice President, PV Operations and Compliance, Senior Pharmacovigilance Operations Specialist will be responsible for the managing drug safety case management vendor, safety submission execution and compliance, and cross functional collaboration to support risk management and pharmacovigilance activities for the Global Patient Safety department.
Responsibilities
• Responsible for operational activities of ICSRs processed by PV case processing vendor.
• Oversee day-to-day ICSR operational activities, processes, training and compliance of PV case processing vendor.
• Ensure timely submission compliance of ICSRs to global regulatory authorities, business partners, CROs and other parties.
• Provide oversight of ICSR regulatory submissions to ensure compliance with global regulations.
• Ensure data reconciliation of the safety and clinical databases for Serious Adverse Events.
• Effectively utilize metrics to assess productivity, opportunities for workflow and quality improvement, and to measure effectiveness of change initiatives.
• Work with VP, PV Operations and Compliance, and other GPS colleagues to ensure PV compliance and inspection readiness.
• Support data readiness for generation and submission of aggregate reports (e.g., DSUR, PBRER, and IDMC listings).
• Collaborate with PV and other functionals to coordinate case management, aggregate reporting, and signal detection activities.
• Collaborate with the preparation of and updates to safety-related study documents (e.g., Safety Management Plans, Reconciliation activities, Database lock activities, etc.)
• Work with VP, PV Operations and Compliance, Quality Assurance team to ensure PV compliance and inspection readiness.
• Additional safety related duties assigned.
Requirements
• Minimum of bachelor’s degree in nursing, pharmacy, or other health care related profession.
• Minimum 5 years of experience in pharmacovigilance operations
• Minimum 4 years of experience in managing end-to-end ICSR case processing activities either internally or through PV vendor(s)
• Experience with Argus safety databases, EDC systems, and electronic document management systems.
• Knowledge of GCPs, GVPs, FDA, EMA, ICH guidelines, and international regulations.
• Proficiency in MedDRA and WHO Drug dictionaries.
• Ability to thrive in a fast-paced, start-up environment and manage multiple priorities.
Benefits
• In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
Apply tot his job
Apply To this Job
The core mission of the Verastem Safety & Pharmacovigilance group is to ensure patient safety for all patient’s receiving Verastem manufactured products. This is done by ensuring that the safety profile of Verastem products remains accurate and up to date throughout the product life cycle of development and through the following core activities:
Relevant safety information including reports of side effects is collected and analyzed.
Possible safety signals are carefully validated and characterized.
Strategies are implemented to minimize risks and to ensure that products are used in a way that maximizes benefits and minimizes risks. Key among these is to ensure that accurate and up-to-date information on the safety profile of Verastem products is available to patients and prescribers in a timely manner. Communication with patients, providers, regulatory agencies, and other concerned bodies is essential to this effort. This includes developing and updating the investigator brochure, and protocols as well as any adjunct information for patients and health professionals. This information must be kept current throughout the life cycle of each product.
Reporting to the Vice President, PV Operations and Compliance, Senior Pharmacovigilance Operations Specialist will be responsible for the managing drug safety case management vendor, safety submission execution and compliance, and cross functional collaboration to support risk management and pharmacovigilance activities for the Global Patient Safety department.
Responsibilities
• Responsible for operational activities of ICSRs processed by PV case processing vendor.
• Oversee day-to-day ICSR operational activities, processes, training and compliance of PV case processing vendor.
• Ensure timely submission compliance of ICSRs to global regulatory authorities, business partners, CROs and other parties.
• Provide oversight of ICSR regulatory submissions to ensure compliance with global regulations.
• Ensure data reconciliation of the safety and clinical databases for Serious Adverse Events.
• Effectively utilize metrics to assess productivity, opportunities for workflow and quality improvement, and to measure effectiveness of change initiatives.
• Work with VP, PV Operations and Compliance, and other GPS colleagues to ensure PV compliance and inspection readiness.
• Support data readiness for generation and submission of aggregate reports (e.g., DSUR, PBRER, and IDMC listings).
• Collaborate with PV and other functionals to coordinate case management, aggregate reporting, and signal detection activities.
• Collaborate with the preparation of and updates to safety-related study documents (e.g., Safety Management Plans, Reconciliation activities, Database lock activities, etc.)
• Work with VP, PV Operations and Compliance, Quality Assurance team to ensure PV compliance and inspection readiness.
• Additional safety related duties assigned.
Requirements
• Minimum of bachelor’s degree in nursing, pharmacy, or other health care related profession.
• Minimum 5 years of experience in pharmacovigilance operations
• Minimum 4 years of experience in managing end-to-end ICSR case processing activities either internally or through PV vendor(s)
• Experience with Argus safety databases, EDC systems, and electronic document management systems.
• Knowledge of GCPs, GVPs, FDA, EMA, ICH guidelines, and international regulations.
• Proficiency in MedDRA and WHO Drug dictionaries.
• Ability to thrive in a fast-paced, start-up environment and manage multiple priorities.
Benefits
• In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
Apply tot his job
Apply To this Job