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Engaged Employer

Apotex Research

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4.1

based on 766 Reviews

3 Apotex Research Senior Analyst Jobs

Senior Analyst, GBS-GPV

APOTEX PHARMACHEM INDIA PRIVATE LIMITED

4.1

based on 766 Reviews

1-3 years

Bangalore / Bengaluru

1 vacancy

Senior Analyst, GBS-GPV

Apotex Research

posted 1mon ago

Job Role Insights

Flexible timing

Key skills for the job

Data Entry Medical Coding Pharmacy Pharmacovigilance Clinical Data Management Compliance

+ 4 more

Job Description

About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
For more information visit: www.apotex.com .

Job Summary

Global Pharmacovigilance (PV) is an operating department within Global R&D. The Global PV department is involved in the processing & submission of adverse drug reaction reports & safety data management to support the development & commercialization of Apotex products in the markets in which we do business, in compliance with global PV regulations & relevant ICH guidelines.

Job Responsibilities

Primary responsibilities

Support PSRM activity by screening & identifying articles of interest for potential signals & aggregate reports from published literature Embase hits. Conducts review of published literature Embase hits to identify ICSRs and other events of special interest.
Perform precision-based data structured field, Quality reviews of ICSRs to ensure compliance with Apotex data entry & processing conventions including, but not limited to, narrative compilation, MedDRA coding assessments & causality assessments.
Perform review of ICSRs, to ensure ICSRs processed in compliance with applicable departmental SOPs & conventions, including but not limited to the review of FU attempts.
Challenge ICSR level data quality issues & non-compliance to conventions/SOPs with the Service Provider.
Perform submission of ICSRs to regulatory authorities, Apotex affiliates & Business partners in accordance with departmental SOPs & HRA legislation.
Timely response to queries related to ICSRs from stakeholders Maintain departmental document management, including scanning & filing of source

Supporting responsibilities

Works in a safe manner collaborating as a team member to achieve all outcomes.
Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, & Passion.
Ensure personal adherence with all compliance programs including the Global Business Ethics & Compliance Program, Global Quality policies & procedures, Safety & Environment policies, & HR policies.
All other relevant duties as assigned.

Job Requirements

Education
- PharmD, MPharm, Nursing or related Health Science discipline
Knowledge, Skills & Abilities
- Excellent English oral/written communication.
- Knowledge of MedDRA, ARGUS & literature review preferred
- Organizational & interpersonal skillsKknowledge of relevant local & international PV regulations & ICH guidelines on safety data management in clinical trials & post-approval
- Knowledge of Microsoft Office: Excel, PowerPoint, Word
Experience:
These will be duly updated as per applicable roles.
- PV experience across safety operations: at least 2-3 years pharmaceutical experience in a PV role
- Quality Review & Submissions: Preferred experience of at least 1-2 years on submission of ICSRs globally
- Literature Validation: Preferred experience of at least 1-2 years on literature validation/literature case processing

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Employment Type: Full Time, Permanent

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