Position: Pharmacovigilance Associate
Location: Bangalore, India
Job Category: Drug Safety
Purpose of the Role:
The Pharmacovigilance Associate is responsible for managing and monitoring the safety aspects of clinical studies and post-marketing surveillance. This includes tasks such as monitoring the safety mailbox, preparing safety management plans, setting up safety databases, processing and submitting ICSRs (SAE/SUSAR/AEs) in compliance with ICH-GCP, SOPs, and regulatory requirements.
Major Responsibilities:
Key tasks for the Pharmacovigilance Associate role include:
Safety Management: Prepare safety management plans and configuration documents, and assist in project kick-off meetings.
Case Processing: Process and draft safety narratives, monitor safety mailboxes, and file study documents.
Unblinding Procedures: Manage unblinding processes where required.
Literature Searches: Conduct searches for adverse event reports and monitor post-approval commitments.
Study Reconciliation: Participate in clinical study reconciliation activities.
Liaison and Collaboration: Communicate with medical monitors, drug safety physicians, clients, and study teams for case processing clarifications.
Regulatory Submissions: Ensure timely submission of safety reports to regulatory agencies and track submissions for compliance.
Training and Mentorship: Provide on-the-job training and mentoring for junior staff.
Qualifications & Experience:
Education:
Registered nurse, pharmacist, or a health/biomedical degree (or other related scientific qualification) is required.
Postgraduate qualifications or certification in clinical trials are an advantage.
Knowledge, Skills, and Abilities:
Clinical Trials & Pharmacovigilance: Strong knowledge of clinical trials and pharmacovigilance requirements, including international drug safety and regulatory reporting obligations.
Medical Terminology: Familiarity with coding medical terminologies and the ability to summarize medical information.
Regulatory Compliance: Understanding of ICH-GCP and related procedural guidelines.
Experience: 2 to 4 years in pharmaceutical/CRO experience with a focus on safety-related areas in clinical trials.
Technology Proficiency: Ability to use specific databases and manage safety data.
Language Skills: Fluent in both written and oral English.
Interpersonal Skills: Good communication skills, with the ability to work with professionals at all levels.
Time Management: Strong multi-tasking and organizational skills.
About Novotech:
Novotech is a global, full-service Clinical Contract Research Organization (CRO) with over 3,700 clinical projects completed, including Phase I to IV trials. We have a strong presence across Asia-Pacific, North America, and Europe, offering expertise in drug development and clinical trials. With over 3,000 employees and 5,000+ site partnerships, we have the resources and infrastructure to scale clinical programs globally.
Employee Benefits:
At Novotech, we foster an inclusive and flexible work environment. We offer:
Flexible working options
Paid parental leave for both parents
Wellness programs
Development programs
We are an equal opportunity employer and support individuals from diverse backgrounds, including those who identify as LGBTIQ+, those with disabilities, or those with caregiving responsibilities.
Application Details:
Deadline: 28th February 2025
Location: Ground Floor, Unit 1, Block E, Helios Business Park, Bangalore, 560103, India.
Contact:
For further information or to apply, please click on Apply Now and follow the online application process.
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