Are you passionate about patient safety and regulatory compliance?
Novotech, a leading global Clinical Research Organization (CRO), is hiring a Pharmacovigilance Associate in Bangalore, India. This is your opportunity to be part of a global team driving innovation in drug safety, clinical research, and medical monitoring.
At Novotech, youโll play a key role in processing adverse event reports, ensuring compliance with global pharmacovigilance standards, and contributing to the advancement of safe and effective therapies.
Key Responsibilities
As a Drug Safety Associate, your daily tasks will include:
- Processing and validating adverse event cases in accordance with SOPs and global regulatory standards.
- Preparing Safety Management Plans, configuring safety databases, and supporting project kick-offs.
- Drafting narratives and conducting literature searches for safety data.
- Managing unblinding procedures and monitoring safety mailboxes.
- Coordinating with medical monitors, clients, and study teams for accurate case data.
- Supporting audits and inspections, and contributing to CAPA (Corrective and Preventive Actions).
- Submitting safety reports to global regulatory agencies and maintaining submission records.
- Training and mentoring junior PV associates.
Required Qualifications
To qualify for the Pharmacovigilance Associate position at Novotech, candidates should have:
- A healthcare or life sciences degree โ B.Pharm, M.Pharm, Nursing, or Biomedical Sciences.
- 2โ4 years of experience in pharmacovigilance, case processing, or clinical safety roles.
- Working knowledge of medical terminology, MedDRA coding, and safety databases.
- Familiarity with SOPs and GxP guidelines.
- Excellent written and verbal English communication skills.
- Strong organizational, time management, and multi-tasking abilities.
Why Join Novotech?
Novotech offers a dynamic work environment that values diversity, inclusion, and growth.
Employee Benefits:
- Flexible working hours and hybrid options.
- Paid parental leave for both parents.
- Professional development and training programs.
- Wellness initiatives for work-life balance.
- Inclusive culture welcoming all genders, LGBTIQ+, and individuals with disabilities.
About Novotech
Novotech is a globally recognized full-service Contract Research Organization (CRO) headquartered in Sydney, Australia, with 34 offices across Asia-Pacific, North America, and Europe. With over 3,000 employees and 5,000+ site partnerships, Novotech provides end-to-end clinical development, regulatory, and data management services to leading biopharma and biotech companies.
How to Apply
