job title:safety specialist 2-regulatory

Aggregate Reports

• Author and review Aggregate Safety Reports (i.e. DSURs, PBRERs, PSURs, PADERs and Canadian Aggregate Reports) and any other aggregate reports as per requirement of the project.

• Review aggregate safety data from the database and generate line listings (LL) and summary tabulations (ST) and include the LL & ST in the appropriate template.

• Analyze safety and regulatory data provided by the client and prepare complete Aggregate Reports according to the client requirements.

• Perform literature screening for inclusion of significant safety articles in respective section of aggregate reports

• Compile benefit risk evaluation sections provided by medical reviewers, as applicable.

• Ensure you comply with internal and external timelines

• Address comments from internal and external/client reviewer(s)

• Finalize reports as per client requirements

• Participate in internal and external audits and inspections by clients and health authorities.

  Signal Management and Risk Management Plans

• Screening, data mining and frequency tabulation for potential signals including signal estimation using appropriate signal detection tool as per the client requirement.

• Generation of line listings and summary tabulations from Argus/client safety database.

• Drafting Signal detection, validation, assessment and benefit-risk analysis and prioritization of signals by reviewing available data.

• Ensuring compliance to appropriate signal SOPs, conventions and guidelines for all activities performed.

• Tracking of identified signals from regulatory and internal signal detection process and monitoring the status of signals: potential signals, open signals, refuted signals and validated signals.

• Developing Risk Management Plans and associated activities as per Navitas Life Sciences/client specific SOPs

Desirable Skills and Experience

• Ability to author and review Aggregate Safety Reports

• PBRER Aggregate Report experience

• Ably assist and support Individual Case Safety Report team as per the workload in respective teams

• Ably Assist and support Literature review team as per the workload in respective teams

• Assist in the scheduling of reports assigned to the team

• Good understanding of medical and Pharmacovigilance terminologies

• Good knowledge of GCP, GVP, ICH, USFDA guidelines and any other pharmacovigilance related guidelines and regulations

• Basic competence with medical and therapeutic terminology.

• Strong understanding of patient safety regulatory obligations.

• Familiar with regulatory and pharmacovigilance guideline

• Good command of written and spoken English; additional languages are favorable

• Good knowledge of usual office software (MS Office: Word, Excel, and PowerPoint)

• Soft skills (motivation, strong communication competence, structured in work, organizing skills, reliability commitment and capacity for teamwork)