Senior Analyst, Drug Information – Risk Management

Apotex Inc.

. Provide verbal and written responses to medical inquiries from healthcare professionals, sales representatives, and internal customers regarding Apotex products .

Posted 9/23/2026full-timeMumbai • IndiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Pharmacovigilance, including the ability to evaluate and respond to medical inquiries, ensure compliance with regulatory standards, and maintain product databases. Proficient in creating and reviewing medical information documents while collaborating effectively within cross-functional teams.

Highest-signal resume keywords

Pharmacovigilance ExperienceMedical Information Document CreationRegulatory Compliance KnowledgeMicrosoft Office ProficiencyArisg Safety Database Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceMedical Inquiry ResponseRisk Management PlansMedical Information ResearchAdverse Event Reporting

Soft Skills

Excellent Oral CommunicationExcellent Written CommunicationTeam Collaboration

Tools & Technologies

Microsoft ExcelMicrosoft PowerPointMicrosoft WordMicrosoft OutlookEmbaseMLM DatabaseMedDRAArgus

Certifications & Qualifications

Bachelor of PharmacyB.Sc. in Health/ScienceMaster of PharmacyBachelor of Dental Surgery

Industry Keywords

ComplianceQuality AssuranceSafety RegulationsHealthcare ProfessionalsInternal Customers

About the role

Key responsibilities & impact

Provide verbal and written responses to medical inquiries from healthcare professionals, sales representatives, and internal customers regarding Apotex products
Evaluate, analyze, and respond to medical inquiries accurately, objectively, and promptly
Coordinate global preparation and updating of Risk Management and Risk Evaluation Mitigation Plans
Contribute medical sections using relevant regional templates
Research and interpret medical information using technical and scientific skills
Create and peer review medical information documents, including response documents, recall Q&As, and bulletins
Participate in departmental and cross-functional business teams and support team initiatives and projects
Ensure compliance with SOPs for adverse event and quality complaint reporting
Maintain awareness of current therapeutics and medical information regulations
Provide on-call coverage according to schedule
Assist with report preparation
Update and maintain product databases and files
Perform special projects and after-hours coverage of the DISPedia unit as assigned
Collaborate as a team member to achieve business outcomes
Adhere to organizational values and global compliance, quality, safety, environmental, and HR policies

Requirements

What you’ll need

Bachelor of Pharmacy, B.Sc. or Diploma in Health/Science related discipline, Master of Pharmacy, or Bachelor of Dental Surgery
Excellent oral/written communication skills
Knowledge of Microsoft Office software: Excel, PowerPoint, Word, Outlook, etc.
Knowledge of Arisg Safety Database, MedDRA and Argus
Knowledge of Embase and MLM database
Knowledge of online literature searching and review
1–3 years of experience in Pharmacovigilance
Ability to comply with adverse event and quality complaint reporting SOPs
Ability to work in accordance with regulatory, compliance, safety, ethics, quality, environment, and HR policies
Ability to provide on-call and after-hours coverage as scheduled

Benefits

Comp & perks

Accommodation for applicants with disabilities as part of the recruitment process
Welcoming and accessible work environment
Supportive and respectful workplace