Pharmacovigilance Specialist Argus

hace 5 meses

Ciudad de México Novasyte A tiempo completo

Your responsibilities will include:

- Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
- Database entry and 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.
- 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 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
- 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
- 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.
- To liaise with client in relation to details on day to day activities as needed.
- 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:
Minimal requirements
- Bachelor’s Degree in Life Science or related field.
- At least 3 yrs experience in pharmacovigilance or related area.
- Advanced experience with Oracle Argus Safety.
- Knowledge of medical terminology
- Fluent language capabilities, including English.

**Skills**:

- Ability to work independently to problem-solve collaboratively and to raise issues appropriately as needed.
- Good interpersonal communication and organizational skills to establish and maintain effective working relationships with co-workers, managers and sponsors.
- Effective mentoring and coaching skills.
- Ability to multi-task, meet strict deadlines, manage competing priorities.
- plan work load based on available capacity and ability to change prioritization based on workload fluctuations also ensuring the quality of deliverables according to the agreed terms.

What you can expect:

- Consistent career growth.
- Leaders that support flexible work schedules.
- Programs and trainings to help you build your pharmacovigilance knowledge.
- Dynamic work environment that exposes you to new experiences.
- Attractive benefits package.

Work conditions
- Home based role.
- Grade 140 (Sr. Role)

LI-Remote #LI-RUBENALEJOS

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

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