Pharmacovigilance Specialist - Jobs in Steinbach, MB

Job Description

Bausch + Lomb Corporation, (NYSE/TSX: BLCO), is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.The company is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses, and other eye surgery products.Our highest priority is the well-being of the people we serve. By listening to our customers and patients, by constantly honing our innovation edge, by executing with integrity and excellence, we strive to earn the trust of our partners and stakeholders.Over the last 167 years, Bausch + Lomb has become a global hallmark for innovation and quality. Our talented and motivated colleagues work relentlessly to invent new materials, engineer new technologies, and ultimately bring new innovations to help people see better to live better.Purpose of Job:Responsible for the establishment and maintenance of the Canadian PV system, coordinating the day-to-day management of the PV system (medicinal products, natural health products, food supplements, cosmetics) and ensuring local compliance with applicable Regulations and Corporate policies (local and global)Provide coordination and support for internal Pharmacovigilance activities within Bausch & Lomb, CanadaEstablish and maintain PV system, in accordance to any new legislationEnsure adverse events processing and reporting systems are in place and up-to-date for all Bausch + Lomb products on the Canadian marketEnsure inspection readinessContributing to Aggregate Reports Team needs related to:Acquire data necessary for Aggregate reports preparationEnsure preparation of all relevant documents for Canadian submission if neededContribute to Global Periodic Report schedule according to authorizations/licenses in CanadaImplement, in conjunction with SDEA Team, local safety agreements with partnersEnsure the Canadian list of products in the CPD is maintained up to dateEnsure submission of Aggregate reports in collaboration with Regulatory AffairsLiaise with Global and local functions for pharmacovigilance activities, as definedContribute to GPRM PSMF updates, as requestedParticipate in Global Aggregate Report Team activitiesParticipate in Submissions and reconciliation activitiesKey Responsibilities:Accountable for all of the activities and deliverables for PV in CanadaMaintain the whole internal and external correspondence coming within his/her duties and activities and ensures relevant archiving of PV documentation if neededCreate and implement local pharmacovigilance SOPs according to local regulations and in line with Global requirements SOPs.Responsible for informing (in collaboration with GPRM team) Canadian Medical and Regulatory team about any safety issues in CanadaEnsure appropriate PV agreements for all Bausch + Lomb, Canada Inc. partnerships in collaboration with SDEA TeamSupport labelling safety update activitiesEnsure local literature review and monitoring of the CanadaVigilance website is in placeEnsure compliance with Health Canadas reporting timelines, as well as for safetyinformation exchanges with partnersManage or assist in management of PV audits and inspections from external regulatory agencies, partners or corporate auditors.Collaborate with other functions like marketing, regulatory to refine the RMP strategiesEnsure seamlessly integration of new acquisitions and divestmentsManage local PV functions conducting PV activities for CanadaManage vendor(s) conducting PV activities for CanadaEnsure safety variations and 72 hours notifications are trackedProvide appropriate and relevant input into projectsParticipate in preparing responses to safety related requests from Health AuthorityEstablish local metrics and other monitoring systems to measure and verify local complianceInform GPRM of changes in local regulation pertaining to Pharmacovigilance.Responsible for preparation of selected Aggregate reports

• Prepare Aggregate reports according to the applicable legal requirements
• Acquire data necessary for Aggregate reports preparation - Prepare or review Summary Tabulations and Line listings - Organize scientific literature review for Aggregate reports - Present all available relevant safety data - Review Aggregate reports prepared by Vendor(s) - Prepare cover letters and all relevant documents for submission if needed - Keep Global Periodic Report schedule up to date - Participate in aggregate reports planning and submission tracking - Archive all source data and relevant files in the defined way - Answer to competent authorities requests - Participate to follow-up of new Regulatory requirements related to aggregate reports - Review Aggregate Reports sections of Safety Data Exchange Agreements

As part of submission and reconciliation activities

• Generate, Review and Transmit CIOMS I form, 3500A FDA MedWatch Form and/or XML file and complete on-time paper and/or electronic (E2B) submission to all Global Agencies, Local Pharmacovigilance Offices and company Partners.-Follow-up with Local Responsible Person for Pharmacovigilance and Partners to ensure on-time submission and confirm receipt of exchange.-Document submission information in global safety database.-Assist in monitoring the Submission and Reconciliation group mailboxes.-Review reconciliation reports with Local Affiliates, Partner Companies, Call Centers and other internal departments and resolve any discrepancies.-Collaborates with business partners to assist with reconciliation issues.-Interact with other internal Departments within the organization to resolve any issues regarding reconciliation.-Assist with corrective action plan for GPRM and complete required forms.-Maintains current knowledge of the assigned products and current regulations governing the processing and reporting of safety data, Standard Operating Procedures and Work Instructions.-Maintain continuous knowledge expertise of local and global requirement for safety reporting.

Qualification:University degree with Pharmaceutical/Medical/Scientific backgroundA minimum of 5 years of relevant work experience in PharmacovigilanceProven oral and written communication skillsLanguages: excellent English skillsTechnical knowledge of job-related systemsUnderstanding of International Pharmacovigilance regulations, GVP, GMP and ISO requirementsComputing skills: user requiring advanced Literacy (Microsoft Officeapplications, Adobe Acrobat, Safety database)The masculine is used in this publication without prejudice for the sake of conciseness.Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. Accommodations for job applicants with disabilities are available on request.Quick Apply

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