Senior Pharmacovigilance Associate
Location: India · Remote
Type: Full-time
About the Company:
Quanticate is the world’s leading data-focused CRO, known for working on complex clinical trials that require expertise in statistical programming, statistics, and data management. Our clients range from top global pharmaceutical companies involved in leading clinical programs to small biotech companies embarking on their clinical development journey.
We emphasize career development by providing membership to professional societies and encouraging active participation in their activities and committees. Together, we can help build a career that enhances your skills, tackles challenging problems, and contributes to the development of clinical therapies that make a difference.
Job Description:
We are seeking a Senior Pharmacovigilance Associate to assist with ongoing pharmacovigilance operations, focusing on the processing of Individual Case Safety Reports (ICSRs). The candidate will ensure adherence to SOPs, regulations, and quality standards under the direction of the Quanticate Team.
Key Responsibilities:
Case Processing: Process spontaneous, literature, and clinical cases as required, ensuring compliance with applicable regulations and Quanticate SOPs.
Triage and Quality Checks: Triage cases for completeness, accuracy, and redaction while determining expectedness against reference safety information for expedited reporting.
Case Notifications: Prepare and submit case notifications to customers, ensuring appropriate follow-up and identification of safety concerns.
Database Entry: Enter safety data onto the safety databases and tracking systems, ensuring adherence to Quanticate or client-specific database conventions.
Coding of Safety Data: Perform manual or auto-encoded coding of adverse events, medical history, and medications.
SAE Reconciliation: Reconcile Serious Adverse Events (SAEs) between Case Report Forms (CRFs) and safety databases.
Literature Searches: Assist with weekly and ad-hoc global literature searches as required, ensuring compliance with SOPs and project-specific Safety Plans.
Abstract and Article Review: Review and classify literature abstracts and articles under the supervision of the PV Scientist.
Safety Database Validation: Support database validation by performing and documenting User Acceptance Testing (UAT).
Project Documentation: Assist the Pharmacovigilance Lead by generating first drafts of project documentation, including Meeting Minutes and SAE report forms.
Requirements:
Education: Pharmacy, life sciences, or healthcare degree. Higher degree or medical qualification is desirable.
Experience: Minimum 2 years of experience in ICSR processing, safety data management, and safety data entry within the pharmaceutical industry or a CRO.
Regulatory Knowledge: Understanding of ICH GCP and other relevant regulations and guidelines.
Database Expertise: Knowledge of industry-standard safety databases such as Oracle Argus, ARISg, or AB Cube SafetyEasy.
Skills:
Strong organizational and interpersonal skills.
Excellent attention to detail.
Good oral and written communication skills.
Analytical and problem-solving abilities.
Benefits:
Competitive Salary
Flexible Working Hours
Holidays: Annual leave, casual leave, sick leave, plus bank holidays.
Medical Insurance: Coverage for self and immediate family.
Gratuity and Accidental Coverage
Professional Development: Learning and development opportunities, including mentoring, coaching, e-learning, and job shadowing.
Recruitment Guidelines:
Quanticate does not ask for payments or deposits during the recruitment process. All legitimate correspondence will come from an @quanticate.com domain. Further information on recruitment processes and tips on staying safe during your job search can be found on our website at Quanticate Careers Guidance.
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