Novotech Hiring Pharmacovigilance Associate

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.

Post : Pharmacovigilance Associate

About the role
The PV specialist is responsible for conducting the PV related work according to ICH-GCP, SOPs, project specific procedures, and applicable regulatory requirements. This role will be based in our Bangalore office and we you MUST have DSUR/writing and preparation experience to be considered for this role.

Responsibilities
• Support to set up the related system and safety database such as ARGUS, ARISg and CRSCube.
• Support to set up and update the related SOPs and ensure the regulatory compliance.
• Support the PV related work in the clinical projects including but not limited to case processing, /adverse event reporting/review of annual safety report, expedite/periodic reporting of safety information to regulatory authorities/investigators/IRBs/sponsors, and the preparation of safety management plan.
• Support to perform post-marketing PV service tasks including but not limited to case handling, literature searching and reviewing, expedited / periodic reporting of safety information to regulatory authorities/sponsors in compliance with regulatory timelines.
• Support to prepare periodic aggregate reports (PSUR/PBRER/DSUR) and Risk Management Plan.
• Conduct the quality control of pharmacovigilance activities to ensure the data accuracy and completion.

Candidate Profile
• Bachelor of pharmacy/nursing/medicine/biology or a related major. A master/PhD degree is preferred.
• You MUST have experience in DSUR Writing/Preparation
• 2+ years Clinical /PV relevant experience is preferred for PV Associate/Specialist; and 4 years or above PV relevant experience is preferred for senior PV Associate/Specialist.
• Knowledge of clinical medicine is a must. Have strong clinical expertise and capabilities of information collection and integrations.
• Familiar with GCP and ability to quickly learn and expert local regulations, ICH related regulations and essential knowledge about therapeutic areas, pharmacovigilance, and clinical trial.
• Proficient in the use of computer software such as MS office applications.
• Understand MedDRA coding.
• Clear verbal and written communication style.

Additional Information
Experience : 2+ years
Qualification : Bachelor of pharmacy/nursing/medicine/biology
Location : India
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 15th May 2026