1. Pharmacovigilance Associate
Location: Trivandrum, India
Work Mode: Office-based or Remote
Req ID: 7953
Job Overview:
The Pharmacovigilance Associate (PVA) plays a pivotal role in ensuring the safety and compliance of pharmaceutical products. The primary responsibility includes processing, reporting, and filing Serious Adverse Events (SAEs) and Adverse Events (AEs). This role requires meticulous attention to detail, adherence to regulatory standards, and effective collaboration with cross-functional teams.
Key Responsibilities:
- Process SAE/AE source data from eCRF systems.
- Review and redact protected information in source documents.
- Enter SAE/AE details into safety databases, ensuring accuracy and compliance.
- Upload notifications, source documentation, and acknowledgments to designated systems such as eTMF.
- Assist in creating CIOMS/MedWatch forms and pdf bundles for designated studies.
- Track and report project progress, ensuring all deliverables are on time.
- Support safety reporting and follow up on outstanding queries.
Job Requirements:
- Education: Degree in Healthcare or Life Sciences is advantageous.
- Experience: Prior experience in computer applications or administrative tasks preferred.
- Skills:
- Strong written and verbal communication in English.
- Proficiency in Microsoft Office.
- Basic knowledge of pharmacovigilance, ICH GCP guidelines, and regulatory requirements.
- Attention to detail and organizational skills.
2. Medical Data Associate (Contract Role)
Location: India (Remote)
Work Mode: Home-based
Contract Duration: 6 months
Req ID: 7983
Job Overview:
The Medical Data Associate supports the Medical team in reviewing and managing medical data. This role involves handling queries, preparing reports, and assisting with data cleaning and presentations. It’s an ideal opportunity for professionals with a background in medical data management.
Key Responsibilities:
- Conduct medical data reviews and manage queries in EDC systems.
- Generate query reports and follow up on pending items.
- Track project statuses and deliverables efficiently.
- Prepare medical reports, summaries, and presentations.
- Document interactions and communications, ensuring compliance with guidelines.
- Assist in filing essential documents into the Trial Master File.
Additional Responsibilities:
- Participate in Quality Control and data reconciliation activities.
- Train new team members in query tools and processes.
Job Requirements:
- Education: A degree in Life Sciences, Nursing, or a related field. Equivalent experience (3-4 years) is also acceptable.
- Experience:
- Familiarity with medical terminology is a plus.
- Prior experience with EDC systems (e.g., Medidata RAVE) is highly desirable.
- Skills:
- Proficient in Microsoft Office Suite.
- Basic understanding of ICH GCP guidelines and regulatory requirements.
- Strong time management and teamwork skills.
