Requisition ID 14659BR
Title Associate Director, Safety Intelligence & Quality/Phamacovigilance
Job Category Regulatory Affairs
Job Description PURPOSE:
• The Associate Director of Safety Intelligence and Quality will assist with the functional activities related to the maintenance of the safety profile of the company’s products, in close collaboration with HQ. Responsibilities will encompass the evaluation, reporting and surveillance of clinical and post-marketing safety information with US drug and device safety reporting, in compliance with the local regulations, ICH and internal procedures. Similarly, activities providing both medical and technical information to stakeholders and providing Product Safety representation at assigned product meeting requiring safety input will be part of the associate director’s responsibilities, as wells the medical assessment review and validation of incoming adverse events, to ensure correct medical interpretation and consistency in the quality of cases.
RELATIONSHIPS
Reports to the Director of Safety Intelligence and Quality, with cross-functional working relationships within Medical, Regulatory and Marketing. Interacts with counterparts in Global Safety. Works in collaboration with the case processing operation and clinical safety and training operations.
ESSENTIAL FUNCTIONS:
Primary Functions:
•Participates in PRB meetings for all assigned Novo Nordisk products
•Provides Product Safety input to assigned product’s Local Labeling Committee
•Provides Product Safety overview of Patient Support Programs, Market Research, Observational Studies and Registries
•Provides Product Safety overview for safety requirements in relation to social media
•Performs monthly medical reviews of post-marketing, non-serious adverse events in collaboration with Global Safety
•Reviews and disseminates information from the affiliate mailbox, as necessary
•Performs QC overview of single cases
•Handles QC activities, as it pertains to tracking of non-conformities (NCs) and Time Limit Exceeding (TLEs) reports
•Tracks, maintains and develops local safety SOPs and assist with the maintenance of the Product Safety GlobeShare, in collaboration with Safety Data Analysts members
•Reviews clinical trial protocols, as necessary
•Provides Product Safety reviews and safety input for aggregate reports, e.g. PSURs, DSUR, PADER, IND Annual etc., as necessary
•Handles local PSUR and DSUR activities for assigned products, in collaboration with Case Processing managers and Director of Training and Clinical Support.
•Performs QC of GXP activities, in collaboration with Case Processing managers.
•Liaise with local Product Safety staff, as well as with medical, clinical and regulatory on all relevant safety matters.
•Serves as a primary contact, facilitator and communicator of information to other departments within Novo Nordisk US and Global Safety and provides assistance to colleagues in other departments as appropriate for safety activities.
•Complies with all Federal regulations and company SOPs regarding complaint handling and regulatory reporting for adverse experiences, marketed product and clinical investigations.
•Maintains high state of knowledge of AE regulations, guideline and standards related to AE surveillance and regulatory reporting.
Secondary Functions
•Use his/her knowledge of industry regulations and practices regarding product safety to follow the North American Regulatory regulations and SOPs and practices on Adverse Event processing and reporting.
•Reviews individual safety reports for medical content and assess regulatory status for expedited reporting as well as possible signal detection
•May oversee narrative writing, medical evaluation of cases and reconciliation of databases, etc.
•Provides medical input in the safety review of investigational and post-marketing cases
•Work with Safety Operations in HQ, drug information and technical product information to evaluate safety data.
•Lecture/train on safety issues at meetings, sales staff training sessions, medical science liaison training sessions, SOP conferences, as needed.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
An M.D. or D.O. , with up-to-date knowledge of clinical and therapeutic principles, as well as a minimum of 3 years relevant (e.g., drug safety, medical affairs, clinical data management or pharmacovigilance) experience is required.
Computer literacy required.
MedDRA coding experience required.
Excellent Communication Skills – written and verbal English are of significant importance to success in this position.
Department CMR - MEDICAL ASSESSMENT
Position Location US - Princeton, NJ
City PRINCETON
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Title Associate Director, Safety Intelligence & Quality/Phamacovigilance
Job Category Regulatory Affairs
Job Description PURPOSE:
• The Associate Director of Safety Intelligence and Quality will assist with the functional activities related to the maintenance of the safety profile of the company’s products, in close collaboration with HQ. Responsibilities will encompass the evaluation, reporting and surveillance of clinical and post-marketing safety information with US drug and device safety reporting, in compliance with the local regulations, ICH and internal procedures. Similarly, activities providing both medical and technical information to stakeholders and providing Product Safety representation at assigned product meeting requiring safety input will be part of the associate director’s responsibilities, as wells the medical assessment review and validation of incoming adverse events, to ensure correct medical interpretation and consistency in the quality of cases.
RELATIONSHIPS
Reports to the Director of Safety Intelligence and Quality, with cross-functional working relationships within Medical, Regulatory and Marketing. Interacts with counterparts in Global Safety. Works in collaboration with the case processing operation and clinical safety and training operations.
ESSENTIAL FUNCTIONS:
Primary Functions:
•Participates in PRB meetings for all assigned Novo Nordisk products
•Provides Product Safety input to assigned product’s Local Labeling Committee
•Provides Product Safety overview of Patient Support Programs, Market Research, Observational Studies and Registries
•Provides Product Safety overview for safety requirements in relation to social media
•Performs monthly medical reviews of post-marketing, non-serious adverse events in collaboration with Global Safety
•Reviews and disseminates information from the affiliate mailbox, as necessary
•Performs QC overview of single cases
•Handles QC activities, as it pertains to tracking of non-conformities (NCs) and Time Limit Exceeding (TLEs) reports
•Tracks, maintains and develops local safety SOPs and assist with the maintenance of the Product Safety GlobeShare, in collaboration with Safety Data Analysts members
•Reviews clinical trial protocols, as necessary
•Provides Product Safety reviews and safety input for aggregate reports, e.g. PSURs, DSUR, PADER, IND Annual etc., as necessary
•Handles local PSUR and DSUR activities for assigned products, in collaboration with Case Processing managers and Director of Training and Clinical Support.
•Performs QC of GXP activities, in collaboration with Case Processing managers.
•Liaise with local Product Safety staff, as well as with medical, clinical and regulatory on all relevant safety matters.
•Serves as a primary contact, facilitator and communicator of information to other departments within Novo Nordisk US and Global Safety and provides assistance to colleagues in other departments as appropriate for safety activities.
•Complies with all Federal regulations and company SOPs regarding complaint handling and regulatory reporting for adverse experiences, marketed product and clinical investigations.
•Maintains high state of knowledge of AE regulations, guideline and standards related to AE surveillance and regulatory reporting.
Secondary Functions
•Use his/her knowledge of industry regulations and practices regarding product safety to follow the North American Regulatory regulations and SOPs and practices on Adverse Event processing and reporting.
•Reviews individual safety reports for medical content and assess regulatory status for expedited reporting as well as possible signal detection
•May oversee narrative writing, medical evaluation of cases and reconciliation of databases, etc.
•Provides medical input in the safety review of investigational and post-marketing cases
•Work with Safety Operations in HQ, drug information and technical product information to evaluate safety data.
•Lecture/train on safety issues at meetings, sales staff training sessions, medical science liaison training sessions, SOP conferences, as needed.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
An M.D. or D.O. , with up-to-date knowledge of clinical and therapeutic principles, as well as a minimum of 3 years relevant (e.g., drug safety, medical affairs, clinical data management or pharmacovigilance) experience is required.
Computer literacy required.
MedDRA coding experience required.
Excellent Communication Skills – written and verbal English are of significant importance to success in this position.
Department CMR - MEDICAL ASSESSMENT
Position Location US - Princeton, NJ
City PRINCETON
State/Provinces US - NJ
Degree Required Doctorate Degree Required