Career at Linical

≪Position Description≫
The Pharmacovigilance Officer-l provides process-related support to senior Pharmacovigilance staff for drug safety management (clinical trial and post-market) and medical coding activities.
The PVO-I maintains current knowledge of relevant regulations, ICH-GCP, and Standard Operating Procedures (SOPs) to ensure compliance with applicable safety reporting requirements.

▶Duties and Responsibilities
Receives and processes adverse event reports from a clinical trial and/or post market product/device under the supervision of senior pharmacovigilance staff.

Duties may include, but are not limited to the following:
・ Processes AE/SAE reports as per project specific Safety Plan.
・  Entry of safety data into adverse event database(s) and project tracking systems
・  Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting.
・  Draft safety narratives and lndividual Case Summary Reports
・  Code serious adverse events and medical history accurately using MedDRA; and code medications with WHODRUG.
・  For post marketed products determine expectedness/listedness against appropriate label/product package lnsert.
・  ldentify clinically significant information missing from initial reports and follow-up to ensure collection.
・  Ensure the case receives appropriate medical review.
・  Prepare follow-up correspondence consulting the medical staff accordingly.
・ Completes QC review of AE/SAE reports and safety database case entry for other PV team members.
・  Process queries using standard query form and maintain timelines of open queries when necessary.
・  Communicates with study Lead PVO or PV Managers as first point of escalation when an issue arises with site or client.
・ For projects where the client maintains the safety database the PVO will complete and maintain project AE/SAE tracker and Query Tracker as applicable.
・  Provides backup support for other PVOs as needed and/or assigned.
・  Maintains a strong understanding of Linical's safety database conventions or client specific database conventions, as appropriate.

・  Attends internal team meetings to ensure safety related issues/updates are communicated to the team.
・ Possess knowledge of procedural documents, e,g., SOPs and GCP, data entry guidelines.
・  Assist senior pharmacovigilance staff in preparing Medical Monitoring Plan and
Pharmacovigilance safety plans.
・  Maintain and file all study and SAE related documents into the Pharmacovigilance study files in SharePoint as appropriate.
・  Other duties as assigned.

▶Required Skills and Abilities

・  Strong organizational and writing skills; proficient in Microsoft Word, Excel, PowerPoint, Adobe pdf, email, and internet.
・  Solid understanding of medical terminology
・  Understanding of regulatory safety reporting guidelines and/or regulations

▶Education and Experience
・ Associate degree MA, LPN, RN + 1-3 years of safety experience
・  BS/BA+ t-2yrs safety experience
・  MS/MA+ 1-2yrs relevant experience** (X-2 yrs safety experience)
・  PharmD + 1-2 yrs relevant experience (1 yr safety experience) certification
・  Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing Life Sciences, and Chemistry.
・  Actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.

**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Monitor, Regulatory Affairs, or Quality Assurance.

▶Physical requirements
・ Can stand or walk for long periods of time carrying briefcases and/or suitcase in an environment that may include uneven/varied surfaces, ramps, stairs, moving sidewalks, escalators, and elevators.
・ Can tolerate prolonged periods of sitting at a desk and working on a computer.
・ Ability to tolerate air travel.