Pharmacovigilance Operations Specialist 1
The Pharmacovigilance Operations Specialist 1 (POS-1) primary responsibility is SAE case management. This includes but is not limited to: initial case disposition, confirmation of case disposition with Medical Monitor (MM) / Safety Physician Pharmacovigilance (SPPV), receipt of adverse event data, data entry, source document data extraction, draft narrative development, follow-up management 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:
Receipt of incoming case information via project specific mailbox/fax daily OR via an auto generated SAE notification email from TEMPO and/or designated EDC system per project requirements.
Tracking and triage of case information for processing
Prioritize incoming AE/SAE/ER information for further processing and confirm receipt, as required.
Identify potential 7-Day and 15-Day Alerts
Prepares disposition email to notify client of case assessment details (confirmation of serious criteria, expectedness 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.
Conduct active follow-up for clarification and missing case details
Handling of safety information according to given processes and procedures, by Clinipace and/or client SOPs, WPs, 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.
Unblind 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/ SPV
Performs/coordinates expedited reporting according to project requirements
Possesses general working knowledge of local and international PV regulatory framework
Provides oversight/support to less experienced PV Pharmacovigilance team members (PV Associates and Junior PV Specialist) 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)
Fully proficient in the use of Argus Safety
May provide assistance in preparing requests for information (RFI)
Participates in regulatory audits and inspections in cooperation with QA, as needed.
Other tasks as required
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 Junior PVS Specialist.
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.
Basic knowledge of international PV relevant rules and regulations (for clinical trial, post-marketing surveillance and/or medical devices)
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