Pharmacovigilance Associate at BioScript Solutions managing collection, processing, and reporting of adverse events. Ensuring compliance with safety regulations and providing support in pharmacovigilance activities.
Responsibilities
Managing the collection, processing, and reporting of adverse events (AEs) and reconciliation reports
Accountable for recognizing, triaging, and reporting as per the program or manufacturer requirements
Maintaining high compliance standards regarding reporting timelines, quality of reporting, and responding to inquiries from stakeholders
Help conduct Pharmacovigilance compliance activities
Assisting in the initiation of investigations for late AE reports.
Requirements
BSc and/or BA related to Health Science; 1-3 years of experience in Pharmacovigilance/Medical Information/Adverse Event Reporting/Safety Case Processing experience and/or Regulatory or QA is an asset;
Good understanding of safety regulations;
Experience in medical and/or pharmaceutical field(s), including exposure to medical terminology and/or scientific writing is an asset;
Exceptional organizational skills and strong attention to detail;
Proven analytical and proven solving skills;
Preference for an individual with CAPA investigation experience;
Versed in Change Control Management is an asset;
Proficient in conducting Program Compliance;
Above average verbal and written communication skills;
Demonstrated prioritization skills and ability to multi-task to meet tight deadlines;
Bilingual, English/French is an asset;
Comfortable working with computers and technology, specifically the Microsoft Office suite of products.
Benefits
Epic Work-Life Balance: Flexible remote work options because we value your time and well-being.
Growth Opportunities: Committed to fostering a culture of growth, where every team, member is encouraged to pursue new skills, expand their knowledge, and advance their careers.
Vibrant Culture: Over 1,500 team members across Canada and year over year we manage to maintain an overall above industry engagement score by using a monthly pulse survey.
Attractive Compensation: Competitive salary, incentive program, and comprehensive benefits package.
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