Apotex Hiring Associate/Sr. Associate - Global
Pharmacovigilance Postgraduation or Masters or M Pharm Apply Now
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 (internal
and external) 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.
Job Requirments
Postgraduation or Masters or MPharm degree
2 to 5years relevant experience in the
field
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