Apotex Inc Recruitment August 2020. Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations.
Important Vacancy details:
- Post Name: AAssociate/Sr. Associate – Global Pharmacovigilance
- Education : Postgraduation or Masters or MPharm degree
- Experienced:o2 to 5 years
- Location: Mumbai, MH
- Salary :NA
- Openings :NA
Job Description: We have requirement for the post of AAssociate/Sr. Associate – Global Pharmacovigilance in Apotex Inc !
- 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.
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online