Apcer Lifesciences Recruitment notification Details 2021
APCER Life Sciences provides comprehensive drug safety /pharmacovigilance, medical information, medical writing, regulatory services, quality assurance and risk management programs to pharmaceutical and biotech companies globally.
Post tittle – Aggregate Report Strategic Officer
Location – Ahmedabad, Delhi
A graduate/post graduate degree in Pharmaceutical sciences/Life Sciences
Roles and Responsibilities
Manage daily workload in conjunction with Line Manager for coordination of Aggregate reports and any other tasks relevant to the Pharmacovigilance Department
Schedule Kick off meetings, communicate and coordinate with all the cross-functional stakeholders for collation of source data.
Manage quality control and review of aggregate reports (PBRER/DSUR/PADER) for the purpose of periodic submission as per regulations and SOPs.
Prepare minutes of meetings, presentations and tracking of all the activities pertaining to aggregate report.
To contact with other team in APCER and customers/clients in order to achieve required outcomes and meet timelines.
Generation and review of SOPs and work instructions (WIs) and execution of company SOPs.
Management of Compliance with the Company SOPs and regulatory requirements
PSUR, Periodic Safety Update Report, Pader, PBRER, Periodic Benefit Risk Evaluation Report, Periodic Adverse Drug Experience Report, Aggregate Report, PSR, Periodic Safety Report, ACO, DSUR