Operations Specialist 2

Job Overview

Essential Functions
- 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, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan.
- Perform activities related to adjudication as applicable
- Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting.
- Liaise with manager for regulatory tracking requirements and electronic reporting.
- Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
- Ensure to meet quality, productivity and delivery standards per project requirements.
- Ensure compliance to all project related processes and activities.
- Build a positive, collaborative team environment with Safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations Manager as a backup when needed.
- Provide and impart technical and process information to Safety Management and members of operational team on project specific issues.
- Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
- Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects
- set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement.
- Establish and maintain effective team and project service operations communications i.e. provide regular feedback to operations team manager and other relevant stakeholders on project metrics, out of scope work challenges/issues and successes
- effective feedback on project performance to junior members of team.
- 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 completeness of individual training plan and maintain up to date training transcripts.
- Participate or Lead trainings across Safety process service offerings
- participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies.
- 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.
- Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes.
- To liaise with client in relation to details on day to day activities as needed.
- Contribute to achievement of departmental goals
- Perform other duties as assigned
- 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 Scientific or healthcare discipline or allied life sciences Req
- Bachelor's degree in life sciences or related field and up to 5 years of relevant experience, inclusive of up to 3 years of Pharmacovigilance experience. Req
- or equivalent combination of education, training and experience. Pref
- Excellent knowledge of medical terminology. Intermediate
- In depth knowledge and understanding of applicable global, regiona