About Apotex Inc.
Apotex Inc. is a leading Canadian-based global health company dedicated to producing high-quality, affordable medicines for patients worldwide. With nearly 7,200 employees operating across manufacturing, research and development (R&D), and commercial sectors, Apotex distributes its medicines to over 75 countries. The company focuses on developing and delivering generic, biosimilar, and specialty pharmaceutical products. For more details, visit www.apotex.com.
Job Title: Pharmacovigilance Scientist
Job Summary:
The Pharmacovigilance Scientist plays a pivotal role in ensuring the safety and efficacy of Apotex products. This position involves the preparation of Periodic Safety Update Reports (PSURs/PBRERs), literature monitoring, and responding to safety-related queries. The Pharmacovigilance Scientist supports global new product development (NPD) teams and Product Life Cycle Management (PLCM) while maintaining compliance with international safety regulations and ICH guidelines.
Key Responsibilities:
Primary Responsibilities:
Safety Report Preparation:
Draft periodic safety update reports (PSURs/PBRERs/PADERs) for regulatory submissions.
Conduct in-depth monitoring and analysis of safety data, including literature reviews, to maintain awareness of product safety issues.
Safety Query Management:
Provide accurate and timely responses to complex safety-related queries from internal teams such as Regulatory Affairs (RA), Quality Assurance (QA), and NPD project teams.
Compliance Adherence:
Ensure adherence to compliance programs, including Global Business Ethics, Quality policies, and safety and environmental standards.
Additional Responsibilities:
Develop and maintain Standard Operating Procedures (SOPs) and training documents.
Track compliance of internal and external global partners involved in drug safety reporting.
Maintain user-level expertise in Oracle ARGUS and MedDRA terminology.
Supporting Responsibilities:
Offer feedback on departmental process improvements and strategy discussions.
Build strong working relationships with external partners, affiliates, and cross-functional teams.
Interpret and apply pharmacovigilance regulations to ensure compliance with international guidelines.
Remain updated on evolving PV regulations and guidelines.
Job Requirements:
Education:
Physicians, Pharm.D, M.Pharm, Nursing, or related health science discipline.
Experience:
Minimum 2-3 years of core pharmacovigilance experience in the pharmaceutical industry.
Preferred 1-2 years of experience in periodic aggregate safety data reviews and risk management.
Skills & Knowledge:
Strong analytical and problem-solving skills.
Excellent oral and written communication in English.
Proficiency in MedDRA, Oracle ARGUS, and online literature searching is preferred.
Advanced knowledge of Microsoft Office (Excel, PowerPoint, Word).
Deep understanding of international regulations and ICH guidelines for safety data management in clinical trials and post-approval settings.
Why Join Apotex?
Commitment to Inclusion: Apotex values diversity and fosters an inclusive, supportive work environment.
Professional Growth: Be part of a dynamic team that contributes to global pharmacovigilance and safety initiatives.
Accommodations Available: Apotex provides accommodations for applicants with disabilities throughout the recruitment process.
Join a team driven by Collaboration, Courage, Perseverance, and Passion. Make a difference by ensuring the safety and efficacy of medicines for patients worldwide. Apply today!
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Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
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Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Ranchi |Karnataka :
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 :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
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Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |Arkansas :
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Alameda | Albion | Arcata | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redding | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | Temecula | Thousand Oaks | Vallejo | West Valley City | Whittier | Willits |Colorado :
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Cairo |South Yorkshire :
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