Ephicacy, a global leader in healthcare analytics, is inviting applications for the position of Senior Specialist, Clinical Literature Monitoring. This role is perfect for individuals passionate about biomedical literature and its critical role in regulatory, clinical research, and pharmacovigilance processes.
Company Introduction
Ephicacy was founded in 2005 in New Jersey, USA, and expanded to Bangalore, India, in 2009. The company specializes in data analytics services for the life sciences industry. With a global team of experts in biostatistics, clinical programming, and data management, Ephicacy delivers innovative solutions to pharmaceuticals, biotechnology, and healthcare organizations worldwide.
Key Responsibilities in the Job
As a Senior Specialist, Clinical Literature Monitoring, your primary duties include:
- Literature Screening and Adverse Event Reporting:
- Monitor the accuracy and timeliness of biomedical literature screening.
- Ensure compliance with adverse event reporting requirements.
- Coordination and Training:
- Train internal teams and external screeners on screening, indexing, and abstracting.
- Assist in training end-users and fulfilling literature-related requests.
- Regulatory and Compliance Management:
- Liaise with regulatory groups to meet global literature requirements.
- Ensure adherence to copyright compliance and maintain up-to-date regulatory policies.
- Database Management:
- Collaborate with IT to optimize the Company Product Literature Database.
- Maintain data integrity, security, and compliance standards.
- System Development and Collaboration:
- Contribute to the development and integration of literature-related systems.
- Engage with internal and external teams for system upgrades and process optimization.
Qualifications
- Education: Degree in life sciences, information science, pharmacy, or related scientific fields.
- Experience: Minimum 5 years in biomedical literature and pharmacovigilance activities.
Required Skills
- Proficiency in biomedical literature and pharmacovigilance.
- Knowledge of pharmaceutical regulations, both US and ex-US.
- Strong writing skills and attention to detail.
- Time management and familiarity with information storage systems.
Preferred Skills
- Experience with audits, inspections, and SDLC (System Development Life Cycle).
- Familiarity with AI, NLP, and Machine Learning technologies.
- Proficiency in foreign languages and semantic technologies.
