Pharmacovigilance Operations Specialist 3 Job in Clinipace

Job Overview:

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)

Supervisory Responsibilities:

No supervisory responsibilities

Job Requirements:

• Education:
  • 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.

• Experience:

• 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

• Skills/Competencies:

• 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.

• Capabilities:

• 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.

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