Senior Safety Operations Specialist with English language Bucharest

Senior Safety Operations Specialist with English language
Bucureşti
Bucharest, Bucharest, Romania

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at

IQVIA Safety Operations team play an important part in the design, build and execution of
-
- end safety solutions for major pharmaceutical companies and their post market products around the world. We are proud to be an international, diverse team based across the world, with ‘safety hubs’ in Ireland, Poland, Austria, Portugal, Slovakia, Spain, India and USA. Each new joiner is supported by a nurturing management team, collaborative colleagues as well as a clear career ladder with plenty of opportunities to allow you to grow, adapt and shine.  

Apply knowledge and expertise including complex
- 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.

Key Responsibilities:

• 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

• Determining initial/update status of incoming events

• 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.

• 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.

• 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

• Provides effective feedback on project performance to junior members of team

 

Required Skills and Qualifications:

• 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

• Excellent knowledge of medical terminology

• Excellent written and verbal skills in English language

• In depth knowledge and understanding of applicable Safety Database and any other internal/Client applications

• In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements

• Excellent organizational skills, time management skills, attention to detail and accuracy

• Excellent working knowledge of Microsoft Office and
- based applications

• To demonstrate effective project management and leadership skills

• Effective mentoring and coaching skills

• Excellent verbal/written communication skills.

• Self-motivated, flexible, receptive to changing process demands

• Ability to identify, prioritize tasks and delegate to team members.

• Extensive use of telephone and
-
- face communication requiring accurate perception of speech.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at