About Apotex Inc.
Apotex Inc. is a Canadian-based global health company producing high-quality, affordable medicines for patients worldwide. Employing nearly 7,200 individuals across manufacturing, R&D, and commercial sectors, Apotex delivers its medicines to over 75 countries. The company focuses on the development and distribution of generic, biosimilar, and specialty pharmaceuticals. For more details, visit www.apotex.com.
Job Title: Pharmacovigilance Specialist
Job Summary:
The Pharmacovigilance (PV) Specialist plays a crucial role in the Global Pharmacovigilance (PV) team within Global R&D. This role ensures the accurate processing, submission, and management of safety data, including adverse drug reaction reports. The PV Specialist supports Apotex's regulatory and commercial operations globally, ensuring compliance with international PV regulations and ICH guidelines.
Key Responsibilities:
Primary Responsibilities:
Literature Review & Signal Detection:
Screen and identify articles from published literature (e.g., Embase) for potential safety signals and aggregate reports.
Review literature hits to identify individual case safety reports (ICSRs) and events of special interest.
Case Quality Review:
Perform structured quality reviews of ICSRs to ensure compliance with departmental conventions.
Assess narrative quality, MedDRA coding, and causality evaluations.
Oversee follow-up attempts and address data quality issues with service providers.
Regulatory Submissions:
Submit ICSRs to regulatory authorities, affiliates, and business partners in accordance with internal SOPs and health authority legislation.
Respond promptly to stakeholder queries related to ICSRs.
Documentation Management:
Maintain and manage departmental documents, including scanning and filing source materials.
Supporting Responsibilities:
Collaborate as a team member to achieve outcomes in a safe, ethical, and compliant manner.
Uphold Apotex's organizational values: Collaboration, Courage, Perseverance, and Passion.
Ensure adherence to all compliance programs, including Global Business Ethics, Quality policies, Safety and Environment standards, and HR policies.
Perform other duties as assigned.
Job Requirements:
Education:
PharmD, MPharm, Nursing, or related health science discipline.
Experience:
Pharmacovigilance Experience: Minimum of 2-3 years in safety operations within the pharmaceutical industry.
Quality Review & Submissions: 1-2 years of experience in ICSR submissions globally.
Literature Validation: 1-2 years of experience in literature validation or case processing preferred.
Skills & Knowledge:
Strong English oral and written communication skills.
Familiarity with MedDRA, ARGUS, and literature review processes.
Proficiency in Microsoft Office (Excel, PowerPoint, Word).
Solid understanding of international PV regulations and ICH safety guidelines.
Strong organizational and interpersonal skills.
Why Join Apotex?
Inclusive Workplace: Committed to a supportive and accessible environment where all employees are valued.
Accommodations: Offers accommodations for applicants with disabilities throughout the recruitment process.
Professional Development: Gain expertise in pharmacovigilance and contribute to global safety initiatives.
Be a part of a team driven by Collaboration, Courage, Perseverance, and Passion, ensuring safe and effective medication use worldwide. Apply today to join Apotex's mission to improve global health.a
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Rangpo |Tamil Nadu :
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Birmingham |Alaska :
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