Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Ass ... view more
Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.
Exposure in handling initial submissions publishing and transmitting quality sub ... view more
Job Description
Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US, and Canada.
Exposure in handling initial submissions publishing and transm ... view more
Experience in Aggregate reporting is a must.
Preparing end to end PSURs (including ad-hoc requests) in accordance with client requirements/conventions and Standard Operating Procedures (SOPs ... view more
RESPONSIBILITIES
Support and execute Pharmacovigilance related activities in UNICHEM Laboratories Limited.
Prepare and maintain Pharmacovigilance documentation and SOPs and train relevant stake h ... view more
Skill required: Pharmacovigilance - Medical Review
Designation: Team Lead/Consultant
Job Location: Bengaluru
Qualifications: Any Graduation
Years of Experience: 7-11 year ... view more