Drug Safety & Data Analytics Associate

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function: Product Safety

Job Sub Function: Pharmacovigilance

Job Category: Scientific/Technology

All Job Posting Locations: Toronto, Ontario, Canada

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Drug Safety & Data Analytics Associate to be in Toronto, CA.

A pre-identified candidate for consideration has been identified. However, all applications will be considered.

Purpose: The candidate will be responsible to support AE intake initiatives to ensure compliance in safety processing, reporting and follow-up activities on Janssen products. Responsible to provide metrics, reports and ensure uploads of source documents in format acceptable in the Global Database system. Responsible to triage, assign and/or conduct intake processing of domestic adverse case reports related to Janssen products. The position verifies accuracy, completeness, and validity of report information during the assessment of follow-up requirements of AE reports. Responsible to use the Canada Vigilance Adverse Reaction Online Database (CVAROD) for MAH related reconciliation activities. Applies clinical judgment when interacting with healthcare professionals and consumers to obtain and follow up on reports of possible adverse events. At this level, the position is expected to participate in activities aligned with the departmental and corporate business objectives. May participate in inspection/audit readiness activities such as the Health Canada GVP Inspection. Assists in the review and implementation of training of intake and follow-up procedural documents.

You will be responsible for:

• Conduct data analysis and modelling to identify patterns and trends in large datasets
• Manage departmental adverse event report intake, initial triage, bulk upload, assignment of cases for further processing
• Develop and implement data driven strategies to improve business operations and decision making
• Collaborate with cross functional teams to identify and prioritize data related projects
• Perform data quality checks and troubleshoot data related issues as applicable
• Extract data from primary and secondary sources and reorganize it into a format acceptable in Global safety database
• Forecasting AE volume and product volume trends on a monthly and annual basis
• Provide regular DSS metric reports to management and other internal stakeholders
• Support departmental requests with GMO for safety database related items
• Monitor intake case processing to ensure timely processing of reports in support of compliance requirements
• Determine and conduct follow-up actions as required with appropriate communication methods (e.g., fax, email, telephone, bulk).
• Support process efficiencies and continuous quality improvements
• Conduct AE reconciliation activities with internal business database(s) e.g., JCS
• Act as Liaison with Linguistics and ensure French source documents are translated and processed in a timely manner
• Manage the translation, update and conversion of all relevant local and global Follow-up and intake forms into bilingual forms.
• Prioritize workload for assigned products and liaise with other Safety and Compliance Associates to ensure timely distribution and processing
• Well versed in identification of all MAH related products and ensure distribution of intake Adverse event reports to appropriate Safety Associates groups thereby contributing to the Compliance metrics of the Department
• Evaluate adverse event reports, assess regulatory status (seriousness and expectedness/relatedness) to prioritize workload.
• Process adverse event reports from spontaneous sources, clinical trials, studies, and marketing activities (including healthcare professionals and consumers) in accordance with company standard operating procedures (SOP) and guidelines for maintaining regulatory compliance. The sources include mail, voicemail, phone, fax, and other electronic means.
• Request product complaint investigation (e.g., PQMS number) on appropriate cases according to the SOP.

Qualifications:

Education:

• University Degree in Pharmacy/Nursing/Medicine/Dentistry or the Canadian equivalent is required.

Experience:

• Experience should include at least 3-5 years in clinical practice or Pharmacovigilance experience
• Advanced level of expertise in Microsoft Excel and a High-level proficiency in Microsoft Tools (Word and PowerPoint) is a requirement
• Position requires strong analytical skills and problem-solving ability
• Project Management certification/skills/equivalent experience with superior level of attention to details is an asset
• Prior work experience with a Pharmacovigilance database

#LI-Hybrid