
Safety Analyst
1 week ago
We are seeking a skilled professional to fill this role.
About the Job:- This is a challenging and rewarding position for someone with strong analytical skills and knowledge of pharmacovigilance.
- The ideal candidate will have a strong background in pharmacovigilance, excellent analytical skills, and the ability to work well under pressure.
- Ensure timely data entry of vigilance cases into relevant databases, adhering to established conventions.
- Conduct quality control checks on vigilance cases and associated safety reports to maintain high standards.
- Perform thorough medical reviews of vigilance cases, following regulatory requirements and conventions.
- Communicate effectively with clients and partners regarding vigilance case follow-ups via phone or mail.
- Pre-analyze complex cases prior to data entry to ensure accurate representation.
- Identify submission requirements for safety cases, guaranteeing compliance with regulations.
- Assist in the preparation of ICSR/MLM filters, ensuring seamless integration with existing processes.
- Review and analyze ICSRs received from competent authorities, maintaining up-to-date knowledge of industry trends.
- Perform reconciliations across various data sources, including partner information, medical details, and quality complaints.
- Collaborate with the team to implement new projects, driving operational efficiency.
- Serve as the primary point of contact for key projects, providing support and guidance to stakeholders.
- Perform medical reviews of post-marketing cases as assigned, utilizing expertise in pharmacovigilance principles.
- Lead operations for assigned post-marketing clients, ensuring seamless project execution.
- Develop and maintain technical agreements, safety management plans, and client templates, aligning with industry best practices.
- Create and update SOPs, WPDs, trainings, and other documents related to pharmacovigilance activities.
- Pharmacist or Life Sciences degree with over 3 years of experience in pharmacovigilance.
- Proven track record of working under deadlines and meeting client expectations.
- Excellent client communication skills, with a minimum of 3 years of experience in QC case analysis.
- Strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
- In-depth knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.
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