Operations Specialist 1

hace 7 meses

Buenos Aires, Argentina IQVIA A tiempo completo

**Purpose**: The position holder will be responsible for Process adverse events with high quality customer service.

**Responsibilities**:

- 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, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan.
- 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.

**Education and Experience**:

- ** Bachelor’s Degree** in a **Life Science** is required. Degree in Pharmacy, Biochemistry, Nutrition, Biotechnology, Biology, Chemistry, Psychology, Genetics
- Experience in Lifecycle safety is desirable, but not mandatory.
- High level of Proficiency in **English C1** (oral/written/reading)

**Work modality.**
- Full Home-based position.
- Full time, regular/permanent contract.
- Based on any city in **Argentina**.

**Comp & Benefits.**
- 4 salary adjustments per year (January, April, July & October)
- OSDE 310, family group (healthcare coverage)
- 3 vacations weeks per year, from 1st year of employment
- Childcare allowance for children btw 0 to 5 yrs. old.
- Annual bonus
- Flexible schedule
- Home based allowance

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