Apotex Pharmacovigilance Associate Vacancy – Apply Online

Apotex Pharmacovigilance Associate Vacancy – Apply Online

Apotex Associate/Sr. Associate – Global Pharmacovigilance Job. Apotex Pharma Job associate Apotex invites postgraduates Pharma candidates for the post of Associate/Sr. Associate – Global Pharmacovigilance. Interested and eligible candidates may apply for this post via online mode. For further details check our website Rasayanika.com.

Job Title: Associate/Sr. Associate – Global Pharmacovigilance

Job Requirments

• Postgraduation or Masters or MPharm degree
• 2 to 5years relevant experience in the field

Job Responsibilities

• Perform medical review of ICSRs and generate follow-up questions as appropriate.
• Conduct a literature assessment for ADRs and medical review of articles.
• Conduct causality assessments for safety cases reports.
• MedDRA coding assessment
• Perform expectedness and listed news 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 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, in compliance with global drug safety regulations and ICH Guidelines. Interacts with health professionals and consumers and affiliate offices during the 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.

Apply Online

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