Pharmacovigilance Specialist SSr/Sr

Job Overview

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.

Essential Functions

• To Prioritize and complete the assigned trainings on time.

• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.

• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events (AE)/endpoint information

• determining initial/update status of incoming events

• database entry

• coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.

• Ensure to meet quality standards per project requirements.

• Ensure to meet productivity and delivery standards per project requirements.

• To ensure compliance to all project related processes and activities.

• Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.

• Creating, maintaining, and tracking cases as applicable to the project plan.

• Identify quality problems, if any, and bring them to the attention of a senior team member.

• To demonstrate problem solving capabilities.

• Liaise with different functional team members, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.

• May liaise with client in relation to details on day to day case processing activities.

• To mentor new teams members, if assigned by the Manager.

• Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.

• Perform other duties as assigned.

• Lead/ Support department Initiatives

• 100% compliance towards all people practices and processes

• In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications.

Qualifications

• Bachelor's degree in Life Sciences (or related field) and up to 3 years of relevant experience in clinical research field, inclusive of up to 1-2 years working in Pharmacovigilance. Required.  

• Excellent command of English (oral/written).

• Good working knowledge of Microsoft Office and web-based applications.

• Good knowledge of medical terminology.

• Working knowledge of applicable Safety Database and any other internal/Client applications.

• Knowledge of applicable global, regional, local clinical research regulatory requirements.

Working conditions

-Full time – permanent contract

-Modality: Home based

-Should be based on Mexico, any city.

To apply, please kindly send us your most updated CV in English language.

#LI-MARIAARECHAGA