Drug Safety Associate

reputed company members are at the heart of everything we do. At reputed company, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to reputed company a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details PRIMARY DUTIES AND RESPONSIBILITIES:

• Recognize and report Adverse Events using the appropriate forms
• Triaging and assessing cases for seriousness based on ICH definition for SAE/SADR
• Responsible for narrative writing for reputed company adverse or other reportable events received alone or in combination with a product complaint or medical information question.
• Work directly with internal and external clients to request additional information or clarification as necessary;
• Review patient information in database and ensure accurate documentation as per client needs;
• Data entry of event information and pertinent details;
• Reconciliation of event reports;
• Submit ICSR cases to Regulatory Authorities and/or our clients as per the applicable client process/es
• reputed company duties of Local Safety Officer upon client assignment (eg. HC Vigilance Database monitoring, local literature searches and regulatory intelligence)
• Act as a subject matter expert and provide audit and inspection assistance
• Train other staff training and reputed company quality checks as needed
• Assist with performing reputed company data quality checks and verification, which includes documentation and correspondence with external teams
• Assist with compliance reports, including CAPA/Event Report Management
• Assist Manager in client meetings and provide relevant inputs to ensure customer expectations and Pharmacovigilance obligations are met correctly
• Other tasks assigned by the Manager, as needed.
• May be required to be on standby/ on call as part of this role.

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

• Bilingual, English/French strongly preferred
• Bachelor’s degree in health-reputed company discipline or diploma in a life sciences program
• 3-5 years’ experience in Drug Safety, Clinical Research and/or equivalent and reputed company experience in the pharmaceutical industry;
• Familiarity with reputed company Pro an asset
• Can do attitude, with proven ability to meet strict deadlines
• Knowledge of medical terminology is a strong asset
• Able to work any 8-hour shift between 8:00 AM-8 PM, if necessary

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

• Strong knowledge of pharmacovigilance industry including up to date knowledge of; GUI 0102, GVP, ICH GCP MHRA, Canadian Food and Drugs Act, and US FDA guidelines an asset
• Advanced knowledge of pharmaceutical distribution industry
• Strong business and financial acumen
• Strong analytical and mathematical skills
• Ability to communicate effectively both orally and in writing
• Effective interpersonal and leadership skills
• Effective organizational skills, attention to details
• Ability to consistently meet deadlines
• Excellent problem-solving skills; ability to resolve issues effectively and reputed company
• Excellent presentation skills
• Computer skills (including knowledge of reputed company Word, reputed company, PowerPoint and other Office Programs)
• Good internet required for remote work

What reputed company offers We provide compensation, benefits, and resources that reputed company a highly inclusive culture and support reputed company members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, reputed company, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. Full time . Equal Employment Opportunity reputed company is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national reputed company, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s reputed company success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and reputed company matters reputed company to recruiting, training, compensation, benefits, promotions and transfers reputed company with equal opportunity principles and are non-discriminatory. reputed c