Case Processing Leader

**Case Processing Leader (PH)**

At Bayer, we work hard to make this company a better place for our employees - and the world a better place for everyone. “Health for all, hunger for none.” That's our vision at Bayer.

Bayer is a global company with core competencies in the areas of life sciences, health care and agriculture. As an innovation company, we set trends in research-intensive areas. Bayer's products and services are designed to benefit people and improve their life quality.

**Position Case Processing Leader**

**YOUR MISSION WILL BE TO**:
The Pharmacovigilance (PV) Case Processing Leader leads a group of data entry and medical evaluation staff at a data entry site for a Therapeutic Area (TA).

He/she manages the entry site TA team to achieve agreed productivity levels and continuously drives process improvements to drive quality and efficiency. He/she contributes to the resource planning and has to manage the workload balancing within the site of the assigned therapeutic area to achieve these goals.

He/she is responsible for ensuring that the PV data entry and evaluator staff provide efficient, timely case processing of high quality, in compliance with an evolving regulatory and scientific environment.
- Manage and lead a group of case processing staff members at entry site, and work collaboratively with remote teams worldwide.
- Supervise case processing and evaluation of all types of Adverse Event reports from spontaneous as well as clinical trial and other organized data collection sources to ensure compliance with health authority requirements regarding ICSR handling.
- Liaise with Global Case Processing TA Head and the TA's Case Processing Leaders in planning for long term and managing the acute resource needs for the TA, as well as workload balancing across the TAs.
- Supervise the group's liaison with CROs as applicable.
- Liaise with the Case Processing Standards Leader and Global Case Processing TA Head in developing and adapting standards for ICSR processing and evaluation, providing input into global Quality Documents and GPV-specific process documents and ensuring his/her group's adherence to global case processing and evaluation standards.
- Maintain and optimize processes for high quality, accurate and timely ICSR processing and evaluation within the respective therapeutic area.
- Incumbent provides input in defining training needs for consistent and high quality case processing and evaluation and ensures that appropriate training is received by his/ her reports.
- Ensures the correct medical coding of AE/SAE and drug terms. This requires in depth knowledge of the present coding systems (MedDRA and WHO-DD) with respect to structure and medical content.
- Analyze and provide regular feedback on QC - findings to individual staff members and define the evolving training needs for TA personnel.
- Provide guidance on complex medical and case processing issues which have been escalated by TA members. This includes specific aggregate analyses and summary description of previous similar reports when required and identification of critical case reports that require immediate attention of the global Risk Management (RM) TA.
- Provide medical/clinical advice for non-medic group members
- Liaise with the PV Risk Management TA members to support the definition of product specific needs for AE/SAE case evaluation (within the confines of global AE case consistency and standards).
- Participate in global AE/SAE reporting compliance analysis and assists in the definition of processes to improve case processing and evaluation. Ensure appropriate corrective and preventive actions (CAPA) including corresponding documentation.
- Deputize for Global SCP TA Head as necessary
- Perform case medical quality control in accordance with company internal standards (rotational assignment)

**ARE YOU READY FOR THE POSITION?**
- MD degree with a combined relevant experience of 6 years, including a minimum of 2 years pharmacovigilance
- Proven capabilities in differential diagnosis; extensive knowledge of drug safety processes, along with proficient understanding of local and global regulations, PV policies and procedures such as ICH principles and PV requirements in major countries.
- Must have good understanding of AE and drug coding conventions (MedDRA, WHO-DD) and should be able to collect, interpret and analyze data from internal and external databases (e.g. Argus, Incidence & Prevalence Database, FDA AERs etc.)
- Proactive behavior and ability to keep timelines and work under time pressure
- Excellent oral and written communication skills are essential.
- Fluency in English is essential (verbally and in writing).
- Fluency in Portuguese are desired
- Proven leadership skills preferred, with demonstrable abilities for organization and supervision including ability to flexibly and quickly realign resources when necessary in order to meet reporting timelines, attract and develop team members
- Advanced int