Senior Safety Specialist

Senior Safety Specialist

Durham, United States of America | Full time | Home-based | R1542305

Job Overview: Apply knowledge and expertise including complex decision making activities to review, assess and process Safety data and information across service lines. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff.

Essential Functions:

• Experience with both clinical trials and post-marketing pharmacovigilance projects
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• To perform Pharmacovigilance activities per project requirement in both clinical trials and post marketing. 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.
• Liaise with manager for regulatory tracking requirements and electronic reporting.
• 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.
• 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.
• To liaise with client in relation to details on day to day activities as needed.
• Perform other duties as assigned
• 100% compliance towards all people practices and processes

Qualifications:

• Bachelor's degree in life sciences or related field and up to 6 years of relevant experience, inclusive of up to 3 years of Pharmacovigilance experience or equivalent combination of education, training and experience.
• Excellent knowledge of medical terminology.
• In depth knowledge and understanding of applicable Safety Databases.
• In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements.
• Excellent working knowledge of Microsoft Office and web-based applications.
• Effective project management and leadership skills.
• Effective mentoring and coaching skills.
• Ability to prioritize multiple tasks, meet strict deadlines, manage competing priorities.
• Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients.
• Ability to work as a Team Player, contribute and work towards achieving Team goals.
• Demonstrate Sound judgment and decision making skills.
• Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams' priorities.
• Ensure quality of deliverables according to the agreed terms.
• Skill to plan work load based on available capacity and ability to change prioritization based on workload fluctuations.
• Skill to negotiate and work on finding a central ground that is satisfactory to all concerned stake holders.
• Experience supporting and preparing for audits.
• Regular sitting for extended periods of time.