Operations Specialist Mgr

Apply knowledge and expertise including complex decision-making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff. May act as functional lead on medium to large operational projects.

• May perform listed job duties in the following groups:
  Regulatory Reporting, Safety Operations, AE Intake, Medical Information, and PV Standards.
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• Perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information.
• Determine initial/update status of incoming events.
• Database entry.
• Code AE and Products, write narratives, Literature related activities, Quality review, assist with reconciliation, case closure related activities, coordinate translations, as per internal/ project timelines. Create, maintain and track 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.
• When acting as functional lead define/set up and document safety reporting procedures in line with IQVIA or customer SOPs, including working with Lifecycle Safety Systems or customer IT teams to ensure regulatory reporting rules and gateways are in place and appropriate delegation for reporting are documented.
• 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 adherence to compliance, quality, productivity and delivery standards per project requirements.
• 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.
• Provide 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.
• 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.
• 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…