Manager, Drug Safety & Surveillance - Janssen Inc. - Toronto, ON-7650130919
Description
About Janssen Inc.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases and women’s health. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.ca for more information.
Position Overview
The Manager, DSS is responsible for leading, coaching and oversight of a team of Drug Safety team members. They will collaborate with Global Medical Safety (GMS), business partners & third parties to clarify procedures, provide input and ensure compliance with Global Medical Safety. They will monitors compliance to Health Canada and GMS, and works with Senior Management and the Drug Safety Manager, Quality and Compliance to identify areas for improvement and communicate this information to the Drug Safety team. They will lead projects aligned with the departmental objectives including technology projects and innovation teams and contributes to business results by driving timelines and deliverables related to the DSS function. In addition, they will perform safety assessments and follow up tasks as required.
Key responsibilities:
Provides oversight to compliance activities including but not limited to : adverse event intake, initial triage, prioritization of reports based on seriousness, case file tracking, case entry as required and submission of cases to Health Canada and affiliates in compliance with regulations, company SOPs and Pharmacovigilance agreements
Manages assigned team members in their daily activities. Supervises and instructs direct reports regarding PV activities to ensure timely and accurate completion of assigned tasks.
Helps the DSS Manager Quality and Compliance to create and track corrective and preventative actions (CAPA) related to non-compliance
Performs periodic case quality check reviews of direct reports and communicates results to management and the drug safety team
Monitors workload and identifies resource needs/allocations to ensure the appropriate functioning of the Drug Safety and Surveillance Department.
Trains internal personnel on PV requirements
Provide ad hoc support for safety related queries as required
Departmental document management in collaboration with management team
Supports internal and external compliance audits in collaboration with departmental management
People Leader responsibility-recruitment/development, ongoing coaching
Lead and/or support local and global projects which are aligned to the DSS one page plan
Qualifications
University degree in Pharmacy or Nursing; Medical degree or the equivalent
Healthcare professional background including but not limited to, pharmacist, nurse, medical doctor, and dentist
Experience should include at least 8-10 years in pharmaceutical industry or clinical practice and/or a minimum of 6 years of drug safety related experience.
Previous supervisory or management experience is required
Demonstrated ability to manage and develop people/teams
Extensive knowledge and experience with safety processing, regulatory compliance, clinical study and spontaneous safety reporting
Excellent understanding of process, training in process excellence an asset
Strong knowledge of pharmacovigilance databases & good knowledge of medical terminology
Superior attention to detail, time management and problem solving skills
Excellent communication and writing skills
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.
J2W:LI NA
Primary Location:North America-Canada-Ontario-Toronto
Organization: Janssen Inc. (7710)
Job Function: Drug & Product Safety Operations
Description
About Janssen Inc.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases and women’s health. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.ca for more information.
Position Overview
The Manager, DSS is responsible for leading, coaching and oversight of a team of Drug Safety team members. They will collaborate with Global Medical Safety (GMS), business partners & third parties to clarify procedures, provide input and ensure compliance with Global Medical Safety. They will monitors compliance to Health Canada and GMS, and works with Senior Management and the Drug Safety Manager, Quality and Compliance to identify areas for improvement and communicate this information to the Drug Safety team. They will lead projects aligned with the departmental objectives including technology projects and innovation teams and contributes to business results by driving timelines and deliverables related to the DSS function. In addition, they will perform safety assessments and follow up tasks as required.
Key responsibilities:
Provides oversight to compliance activities including but not limited to : adverse event intake, initial triage, prioritization of reports based on seriousness, case file tracking, case entry as required and submission of cases to Health Canada and affiliates in compliance with regulations, company SOPs and Pharmacovigilance agreements
Manages assigned team members in their daily activities. Supervises and instructs direct reports regarding PV activities to ensure timely and accurate completion of assigned tasks.
Helps the DSS Manager Quality and Compliance to create and track corrective and preventative actions (CAPA) related to non-compliance
Performs periodic case quality check reviews of direct reports and communicates results to management and the drug safety team
Monitors workload and identifies resource needs/allocations to ensure the appropriate functioning of the Drug Safety and Surveillance Department.
Trains internal personnel on PV requirements
Provide ad hoc support for safety related queries as required
Departmental document management in collaboration with management team
Supports internal and external compliance audits in collaboration with departmental management
People Leader responsibility-recruitment/development, ongoing coaching
Lead and/or support local and global projects which are aligned to the DSS one page plan
Qualifications
University degree in Pharmacy or Nursing; Medical degree or the equivalent
Healthcare professional background including but not limited to, pharmacist, nurse, medical doctor, and dentist
Experience should include at least 8-10 years in pharmaceutical industry or clinical practice and/or a minimum of 6 years of drug safety related experience.
Previous supervisory or management experience is required
Demonstrated ability to manage and develop people/teams
Extensive knowledge and experience with safety processing, regulatory compliance, clinical study and spontaneous safety reporting
Excellent understanding of process, training in process excellence an asset
Strong knowledge of pharmacovigilance databases & good knowledge of medical terminology
Superior attention to detail, time management and problem solving skills
Excellent communication and writing skills
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.
J2W:LI NA
Primary Location:North America-Canada-Ontario-Toronto
Organization: Janssen Inc. (7710)
Job Function: Drug & Product Safety Operations