Pharmacovigilance Operations Specialist 3
The Pharmacovigilance Operations Specialist 3 (POS-3) primary responsibility is SAE case management and regional safety project management. This includes but is not limited to: initial case disposition, confirmation of case disposition with the Medical Monitor (MM) / Safety Physician Pharmacovigilance (SPPV), data entry, source document data extraction, draft narrative development, follow-up management, quality control checking, and reporting according to regulatory requirements. All activities will be in accordance with Clinipace and/or client SOPs, ICH Guidelines and local regulatory requirements.
Job Duties and Responsibilities:
Review of global triage spreadsheet to identify incoming case information via Global SAE Inbox daily, including information received by fax/email or via an auto generated SAE notification email from the designated EDC system per project requirements.
Tracking and triage of case information for processing.
Prioritizes incoming AE/SAE information for further processing and confirm receipt, as required.
Identifies potential 7-Day and 15-Day Alerts.
Prepares disposition email to notify client of case assessment details (confirmation of serious criteria, preliminary expectedness assessment and causal association) as required.
Assumes case ownership responsibility for non-serious, spontaneous and/or serious clinical trial domestic and foreign cases, as applicable.
Consults with multiple stakeholders (e.g. the sponsor / medical monitor / pharmacovigilance physician) to decide on action and/or additional steps to provide complete narratives to the sponsor.
Conducts active follow-up for clarification of discrepant or missing case details.
Handling of safety information according to given processes and procedures, by Clinipace and/or client SOPs, Working Procedures and Guidelines.
Enters initial and follow up information in the Clinipace safety database or client’s database, according to project requirements, as required.
Reviews and/or performs coding for all required medical/drug terms according to given coding dictionaries and applicable coding guidelines.
Develops case narratives, per project specific template.
Performs quality control (QC) checks for safety database entry and narratives
Unblinds treatment codes in studies, if applicable.
Creates safety line listings as required.
Provides final narrative and/or CIOMS I form/MedWatch form to the client after review by the MM/ SPPV.
Performs/coordinates expedited reporting according to project requirements.
Acts as regional lead for PV projects, including coordinating workflow, preparing study metrics and responding to client requests
Possesses general working knowledge of local and international PV regulatory framework.
Supervises less experienced PV Pharmacovigilance team members in the performance of tasks.
Additional tasks and responsibilities depending on the level of experience:
Data retrieval from safety databases or EDC system
Supports the work of Pharmacovigilance by generating ad hoc adverse event reports (data retrieval) according to input or by request of Safety Physician
Generates validated ad hoc reports as well as periodic reports from safety database as requested
Expert for coding (MedDRA and other coding dictionaries)
Expert for Argus Safety, including serving as intermediary between Users and IT
Maintenance activities for the User Manual of the Argus Safety Database
Participates in regulatory audits and inspections in cooperation with QA, as needed
Participates and present in client, team, or investigator meetings (as applicable)
Clinical Event Committee (CEC) – support, triage cases for ad judicable events, prepare packets for committee review, as requested.
Assistance in preparing PSURs, DSURs, RMPs, signal management documents, and others, as applicable (e.g., review of periodic listings for detection of potential safety signals, quality control of documents)
No supervisory responsibilities
Degree in life science or nursing/pharmacy qualification or other advanced or equivalent appropriate healthcare or pharmaceutical industry experience or education, e.g. laboratory experience.
Medical Documentalist, Medical Documentation Assistant, Nurse with extensive clinical experience or life science degree (e.g. natural scientist with a degree in biology, pharmaceutical medicine of similar specialty) preferred.
At least to 2-3 years’ experience in the tasks and responsibilities performed by a Pharmacovigilance Operations Specialist 2 or equivalent role
Advanced proficiency in use of safety database and/or EDC system (per client directive).
Advanced knowledge of medical terminology.
Deep understanding of drug development and safety data processing and working processes.
Advanced knowledge of international PV relevant rules and regulations (for clinical trial, post-marketing surveillance and medical devices)
Experience in Project Management
Other tasks as required
General knowledge of drug therapy, disease states, clinical research.
Applies working knowledge of pharmacovigilance processes and requirements to complex situations.
Good medical knowledge, ability to analyze, draw conclusions, and formulate recommendations related to potential safety issues.
Excellent computer knowledge. Use of MS Office applications to a competent standard for Word, Excel, and PowerPoint.
Good working knowledge of regulatory reporting requirements and international regulations (as required for assigned projects).
Willingness to provide guidance and training to less experienced staff.
Willingness for continuous on the job training and qualifications measures.
Basic understanding of financial aspects of projects.
Practices professionalism and integrity in all actions – demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done.
Works through conflict and drives productive resolution.
Ability to prepare draft working procedures, templates and/or training material.
Ability to review and provide input for SOPs, working procedures, guidelines.
Ability to review and give input to draft Safety Management Plan (SMP)
Ability to provide quality control (QC) of scheduled expedited reports within safety database and/or designated EDC system, as applicable.
Ability to process or retrieve safety information, initiate searches and/ or generate reports from the safety database or designated EDC system, as applicable.
Ability to maintain and protect client, patient and corporate confidentiality.
Ability to work in an environment of rapidly changing priorities and manage multiple client projects.
Ability to review medical data from clinical trials and post-marketing experiences, as applicable.
Ability to organize and manage work to meet strict timelines.
Ability to provide exceptional customer service and professional interactions with a varied customer base, as necessary.
Ability to work independently with high reliability and a high sense of responsibility.
Ability to work as a member of a team and possession of confident communication skills both written and verbal.
Ability to communicate in English (both written and verbal).
Ability to work with careful attention to details.
Up to 5 % travel, as needed, for project team meetings, client presentations and other professional meetings/conferences
Location: Anywhere in India
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