Pharmacovigilance Jobs: Novotech is Hiring a Drug Safety Associate – Apply Now For Novotech Career
If you are actively looking for Pharmacovigilance Jobs, here is an opportunity. Novotech Career is seeking a Pharmacovigilance Associate (Drug Safety Associate) in India. This role offers an excellent opportunity to contribute to global safety operations by managing adverse event case processing, ensuring regulatory compliance, and collaborating with international clinical study teams. If you have 2–4 years of experience in pharmacovigilance or safety-related areas, this position offers a dynamic, growth-oriented environment within a world-class CRO.
Job Details:
- Job Title: Pharmacovigilance Associate (Drug Safety Associate)
- Location: India
About the Company:
Novotech is a global full-service Clinical Contract Research Organization (CRO) headquartered in Sydney, Australia, with 34 offices across Asia-Pacific, North America, and Europe. Employing over 3,000 professionals, Novotech has more than 5,000 site partnerships, offering scalable regional and global solutions for advancing clinical programs.
The company provides end-to-end clinical development services, including feasibility studies, ethics and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, and report writing compliant with ICH standards.
Novotech holds ISO 27001 (Information Security Management) and ISO 9001 (Quality Management) certifications, reflecting its commitment to world-class standards of quality, security, and regulatory compliance.
Education:
- Registered nurse, pharmacist, or degree holder in health, biomedical, or related scientific fields.
- 2 to 4 years of experience in the pharmaceutical or CRO industry, focusing on safety-related areas in clinical trials.
Responsibilities for a Drug Safety Associate:
- Prepare safety management plans and safety database configuration documents for each project.
- Create slides for project kick-off meetings.
- Conduct case processing activities, draft safety narratives, monitor the safety mailbox, and file study documents in the TMF.
- Manage unblinding procedures and conduct literature searches to monitor adverse event reports and post-approval commitments.
- Participate in clinical study reconciliation activities as requested by the client.
- Liaise with medical monitors, drug safety physicians, clients, and study teams to clarify case information.
- Participate in inspection and audit-related activities and assist in implementing corrective and preventive actions.
- Submit reports to regulatory agencies in compliance with applicable regulations and track submissions.
- Provide on-the-job training and mentorship to junior staff.
Experience:
- Experience in medical coding, case processing, and safety report submission preferred.
- Strong knowledge of medical terminology and ability to summarize medical data.
- Proficiency in database systems and computer applications.
- Ability to follow SOPs, guidelines, and procedural documentation.
- Excellent communication skills in written and spoken English.
- Strong interpersonal skills, time management, and multitasking ability.
