Drug Safety Associate

3 days ago

Bengaluru, India Merck KGaA Darmstadt Germany Full time

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimageable with us.

**Education**:

- Medical or scientific background
- Advanced level of written and spoken English
- Familiarity in English medical terminology
- Solid professional skills

**Work Experience**:

- 2 to 4 years related experience in a medical or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge which should include 1 - 2 years in Drug Safety.
- Good problem solving skills

**Breadth of Technical / Functional Skills**:

- Performs timely data processing in the GPS database for received source documents of cases collected during GPS monitoring of drugs and compounds of the Company Group: This includes triage, data entry, coding and narrative writing of individual case safety reports, in accordance to the safety database and 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.

**Specific Skills**:

- Knowledge of FDA and EMA regulations, ICH guidelines including GVP Module VII, Good Clinical Practices, and the drug development process and MedDRA
- Strong organizational skills.
- Good interpersonal skills and the ability to work within a team in collaborative and supportive role.
- Excellent written and verbal communication skills.

**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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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