PV Associate (Woodbridge)

PV Associate Department: Pharmacovigilance Company: Auro Pharma Inc. Industry: Generic Pharmaceutical Type: Permanent About Auro Pharma Inc. Auro Pharma Inc. is the Canadian subsidiary of Aurobindo Pharma, a vertically integrated global pharmaceutical company with operations in over 165 countries and more than 40,000 employees worldwide. We specialize in the manufacturing of drug intermediates, APIs, finished formulations, and R&D. Auro Pharma Inc. offers a diverse portfolio of oral and injectable prescription products across key therapeutic areas including Anti-Infective, Anti-Retroviral, Cardiovascular, CNS, and Pain Management. Our distribution network spans all major channels across Canada. Position Summary The Associate of Pharmacovigilance will be responsible for triaging adverse event information, performing and supporting pharmacovigilance activities, and assisting the Head of Pharmacovigilance to ensure that processes remain compliant with current Good Pharmacovigilance Practices and the Food and Drug Act. Responsibilities Record, process and report Individual Case Safety Reports (ICSRs) in a timely manner as per Health Canada requirements. Process Individual Case Safety Reports (ICSRs), foreign cases, and extract data from the Argus safety database. Assist and provide necessary data to Aurobindo Global Pharmacovigilance Department (GPVD) for annual summary reports, Periodic Safety Update Reports (PSURs) and product quality reviews. Provide daily, monthly and consolidated case log status for the preparation of Monthly Compliance Reports (MCR) for domestic, foreign and serious unlisted cases, and perform reconciliation as required. Prepare and organize documentation required for audits and Health Canada inspections. Participate in audits and Health Canada inspections, preparing and organizing required documentation for inspectors. Train all staff members on pharmacovigilance activities. Record and report Adverse Drug Reactions (ADRs) received from Health Care Professionals and consumers to GPVD for assessment and submission to Health Canada, when applicable. Respond to medical information requests from Health Care Professionals and consumers, maintain a database of requests, responses, and sources. Act as liaison between GPVD and Canadian regulatory authorities. Perform local literature searches for adverse reactions involving products commercialized by Auro Pharma in Canada. Monitor the Health Canada database for adverse reactions involving Auro Pharma products in Canada as part of the Canada Vigilance Adverse Reaction Online Database Search. Qualifications B.Sc. degree in Chemistry, Biology, Pharmacy, Life Sciences or a similar discipline with a strong scientific background. Minimum of 3-5 years of pharmacovigilance experience in a pharmaceutical or drug manufacturing setting. Extensive current knowledge and experience with cGMP & GVP regulations. Excellent written and oral communication skills. Benefits Company events Dental care On-site parking Paid time off Vision care RRSP match Schedule Monday to Friday Work Location In person Pay From $55,000.00 per year Equal Opportunity Statement Auro Pharma Inc. is an equal chance employer committed to fostering a diverse and inclusive workplace. Reasonable accommodation is available upon request throughout the recruitment and selection process. #J-18808-Ljbffr Auro Pharma