As the first Merck subsidiary in Asia, Merck Limited (formerly E. Merck Limited) was founded in India in 1967. The company runs both its Chemicals and Pharmaceuticals businesses there. In 1981, Merck became the first member of the Merck Group to list on the stock market. Currently, the Merck Group owns 51% of Merck Limited’s share capital, with the remaining 49% traded on the Bombay Stock Exchange Ltd.
Nam of Post: Drug Safety Associate
Experience: 2 to 4 years
Qualification: Medical or scientific background
Location: Bangalore
Industry Type: Pharma / Healthcare / Clinical research
Job Description
- 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
- Computer skills to include, advance knowledge of MS Office (Word, Excel, PowerPoint, Outlook) MS Project and database applications.
- 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.
Candidate Profile
- Medical or scientific background
- Advanced level of written and spoken English
- Familiarity in English medical terminology
- Solid professional skills
- 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
Last Date : 30th May, 2023
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