APOTEX Associate/Sr.
Associate - Global Pharmacovigilance
Apotex is a
proudly Canadian, global pharmaceutical company that produces high-quality, affordable
medicines (both generic and innovative pharmaceuticals) for patients around the
world. We are the 7th largest generic pharmaceutical company globally with more
than 12,000 employees and estimated sales of approximately $3 billion. Our
fully integrated operation is comprised of four lines of business: Global
Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and
ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex
can produce up to 24 billion dosages per year. We produce 300 medicines in
4,000 dosages and formats that are exported to 115 countries. Apotex will spend
$2 billion over the next 10 years on research and development.
Job Summary
Performs
global Pharmacovigilance processes of the unit: Medical assessment and quality
review of Individual case safety reports (ICSR), including submission to
regulatory authorities as needed; Compliance monitoring and tracking;
Reconciliation; Literature review, and occasional case processing as needed.
Contributes to drafting and review of aggregate reports and Risk Management
plans on products developed and manufactured by Apotex, in compliance with
global drug safety regulations and ICH Guidelines. Interacts with health
professionals and consumers and affiliate offices during investigation of all
case reports. When required, participates in global new product development
(NPD) project teams and supports Product Life Cycle Management (PLCM)
activities relating to Risk Management programs as required.
Job Responsibilities
Perform
medical review of ICSRs and generate follow-up questions as appropriate.
Conduct
literature assessment for ADRs and medical review of articles.
Conduct
causality assessments for safety cases reports.
MedDRA coding
assessment
Perform expectedness
and listedness assessment and ICSR reportability.
Conduct
quality review of ICSRs.
Contribute to
submissions of ICSRs when required.
Assist in the
preparation, review and evaluation of signals, aggregate reports and risk
management plans
Contribute in
generating responses to regulatory authority requests on product safety related
issues for marketed products or product in development.
Respond to
queries from clients (including internal and external to Apotex Inc.) in a
timely manner.
Perform monthly
or quarterly reconciliations of reports as required.
Assist in the
maintenance of unit SODs, Safety Data Exchange agreements with business
partners and internal work instructions.
Maintain
departmental document management, including scanning and filing of source
documents.
Contribute to
maintenance and compliance oversight of PV processes, external service
providers and business partners. May contribute to preparation and training of
internal and external customers on adverse events reporting
Escalates to
Project Leader, calls and requests for Health Care Professional consultation
involving safety issues.
Contribute to
process improvement initiatives in consultation with management.
Works as a
member of a team to achieve all outcomes.
Performs all
work in support of our Corporate Values of Collaboration, Courage,
Perseverance, Passion; Demonstrates strong and visible support of our values.
Performs all
work in accordance with all established regulatory and compliance and safety
requirements.
All other
duties as assigned.
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