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Senior Analyst, GBS-GPV
1-3 years
Bangalore / Bengaluru
1 vacancy
Senior Analyst, GBS-GPV
Apotex Research
posted 2mon ago
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Flexible timing
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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 .
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.
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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What people at Apotex Research are saying
Rating based on 14 Senior Analyst
reviews
Anonymous · Other
in Mumbai
Likes
Canadian based global health care company, great place to work, culture is so good, provides hybrid work model
- Salary - Good+5 more
Dislikes
Promotion/appraisal is biased
Senior Analyst salary at Apotex Research
reported by
85
employees
with 1-6
years exp.
₹3
L/yr - ₹8.3
L/yr
36%
less
than the average Senior Analyst Salary in India
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What Apotex Research employees are saying about work life
based on 772 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Apotex Research Benefits
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