Senior Pharmacovigilance Specialist - Remote
Highlights:
• Pre and post marketing PV experience
• PV Planning in clinical trials
• DSUR,PSUR/PBRER
• RMP writing
POSITION SUMMARY
The Senior Pharmacovigilance Specialist is a professional with scientific, clinical, and therapeutic area expertise responsible for case management activities, expedited/non-expedited reporting activities, periodic reporting activities, risk management, signal detection and surveillance, ad-hoc reporting, and participation in safety meetings for drugs, biologics, devices, vaccines, cosmetics, and/or animal products, according to applicable Standard Operating Procedures (SOP), project specific supporting documents, ICH Good Clinical Practice (ICH GCP), Good Pharmacovigilance Practice (GVP) and all other applicable regulations and standards.
Senior Pharmacovigilance Specialists tasks depend on the process/project/role assigned.
ESSENTIAL FUNCTIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
Essential Functions Statement(s):
• Demonstrate proficiency in the use of the safety database and associated safety system(s).
• Demonstrate proficiency with MedDRA and WHODrug coding
• Integrate scientific expertise with knowledge of safety database functions to ensure accurate and comprehensive case data entry and identification of follow-up requirements for all case types, received from multiple sources, such as spontaneous, clinical trial, post-authorization safety studies, scientific literature, etc
• Monitors the Client email Inbox, performs review, analysis, triage and filing of safety information within established timeframes
• Processes safety information in relevant computerized system (e.g. PV database): data entry, MedDRA and WHODrug coding, case narrative writing, quality control, reconciliation, as per client specific requirements
• Ensures quality, compliance and consistency of all steps of case processing activities (case management)
• Cooperates with the Medical Reviewer to collect all required information and determine AE medical assessment
• Complete medical literature search activities for pharmacovigilance purposes
• Complete social media search activities for Client products for pharmacovigilance purposes, if needed
• Contributes and/or assists in preparation (writing, compilation) of expedited and periodic safety reports (including Suspected Unexpected Serious Adverse Reactions (SUSAR), DSUR, Line listings, IND safety reports)
• Assistance/writing of aggregate safety reports (PSURs/PBRERs, ADCOs, PADERs etc.), DSURs, risk management plans and signal detection reports
• Knowledge of regulatory and compliance guidelines to ensure expedited and non-expedited submissions to the
• appropriate entities
• Knowledge of regulatory and compliance guidelines to ensure periodic report submission to the appropriate entities
• Knowledge of regulatory and compliance guidelines to ensure risk management activities are completed and reported within regulatory determined timelines to the appropriate entities
• Create and review ad-hoc reports from the safety system and associated safety tools
• Completes Quality Review of periodic reports and ad-hoc reports
• Completes Quality Review of data retrieved from the safety system and associated safety tools
• Assisting as member of the safety management team in the determination of whether new safety information requires amendment to Clinical Trials documentation
• Develops PV documentation including: SOPs, Work Instructions, Safety Management Plans under TLs or PV Quality Manager(PV QM) supervision
• Ensures that all PV documents are filed according to SOPs and project requirements
• Effectively communicates with internal and external stakeholders, participates in internal and external team meetings
• Maintains and develops professional knowledge by participating in internal/external trainings and by self-learning;
• Shares PV knowledge and expertise with PV team, other departments and Clients, actively promoting patient safety principles and awareness
• Acts as a mentor and trainer for new PV employees (shares knowledge, performs content quality check, provides support in issue solving)
• Participate in staff training and other measures to ensure Med Communications International compliance with Client quality guidelines and key performance metrics.
• Supports the role of the QPPV and interacts as required.
• Assists in collection, verification and tracking of local and global safet