Medical Information and Pharmacovigilance Lead

IQVIA RDS Slovakia, s. r. o.

Place of work
Vajnorská, Bratislava
Contract type
plný úväzok
Start date
ASAP
Wage (gross)
2 300 EUR/month

Information about the position

Job description, responsibilities and duties

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.
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.
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.
100% compliance towards all people practices and processes

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)

Language skills

English - Advanced (C1) alebo Dutch - Advanced (C1) alebo French - Advanced (C1) alebo German - Advanced (C1) alebo Italian - Advanced (C1) alebo Spanish - Advanced (C1)

Personality requirements and skills

Life sciences and/or health knowledge with analytical skills.
Excellent knowledge of medical terminology.
Excellent written and verbal skills in English and another native language: French or Spanish or Italian or German or Dutch.
Excellent attention to detail and accuracy maintaining consistently high-quality standards.
Excellent organizational skills and time management skills.
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.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage competing priorities.

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Brief description of the company

At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA.

Number of employees

1000 and more employees

Company address

IQVIA RDS Slovakia, s. r. o.
Vajnorská 100/B
831 04 Bratislava - mestská časť Nové Mesto
https://www.iqvia.com/

Contact

Kontaktná osoba: Erika Kostkova
E-mail: poslať životopis
ID: 3985390  Dátum zverejnenia: 12.10.2020  Základná zložka mzdy (brutto): 2 300 EUR/month