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Mamc-o Drug Safety Associate

4 months ago

Bengaluru, India Merck KGaA Darmstadt Germany Full time

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Performs timely data processing in the GPS database for received source documents of cases collected during GPS monitoring of drugs and compounds of the Merck Group: This includes triage, data entry, coding and narrative writing of individual case safety reports, in accordance to ARISg safety data processing and medical evaluation guidelines as well as SOP
- Ensures integrity and consistency of data against source document by performing QC and appropriate correction of all processed cases in appropriate timelines as per SOP.
- Performs Sample QC of cases within Activity due dates as per Safety data processing guidelines and SOP.
- Provides feedback on potential improvement on data entry and safety database system changes as well as additional training needs
- Provides trainings of global case processing processes upon request
- Ensures completion of all mandatory HR4YOU trainings well within due dates.
- Support training the new joiners (Train and support on case processing and Sample QC process, provide feedback on cases processed).
- Supports audits and inspection process.

Communication is mainly focused to all departments within Global Patient Safety
- Processes, manages and discusses all types of GPS safety cases
- Provides feedback on potential safety data processing guidelines and safety database changes.
- Provides support to GPS System Group in case of database system changes as appropriate.
- Exchanges case documentation with partners (CROs, GCO, MASC (Medical Affairs Study Coordination), LPSOs, local data entry sites, license partners) and tracks these exchanges

**Case Triage**
- Ensures execution of intake and triage activity as per defined quality documents and safety data processing guidelines.

Case Processing
- Makes sure that all received case reports are processed within the agreed workflow timelines as per safety data processing guidelines and SOP timelines.
- Attaches source documents in the safety database system.
- Writes narrative case summary as per conventions.
- Codes patient's reactions, diseases, drugs and indications with available dictionaries (MedDRA, WHO Drug Dictionary, company drug dictionaries) as per conventions.

**Quality Control**
- Makes sure that all processed cases are checked (QC'ed) against source data in quality and within the agreed workflow timeline and that all required corrections are performed as necessary.

**Case Management**
- Makes sure that any activity described above is appropriately documented.
- Ensures that case documentation is sent to appropriate business partner.

**Sample QC**
- Make sure all the cases received in Sample QC workflow are reviewed within the activity due dates against safety data processing guidelines and SOP.
- Document all the feedbacks appropriately.
- Review the feedback from waivers and train the team on same.

**Training and Mentoring**
- Participate in training the new joiners on case processing related activities.
- Provide appropriate and timely feedback for cases reviewed and educate the new joiners on common findings.

**What we offer**: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life

Job Requisition ID: 259450

Location: Bangalore

Career Level: C - Professional (1-3 years)

Working time model: full-time

**North America Disclosure**

+91-XXXXXXXXXX from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

**Notice on Fraudulent Job Offers**
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