Merck Pharmacovigilance jobs in Bangalore; Drug Safety Associate
- Merck Pharmacovigilance jobs in Bangalore
- Job Description
- Education
- Work Experience
- Technical / Functional Skills
- Specific Skills
- What We Offer
- FAQs
- 1. What are the primary responsibilities of a Drug Safety Associate?
Merck Pharmacovigilance jobs in Bangalore
As a Drug Safety Associate, you have the opportunity to explore, break barriers, and discover more with us. We are a global team of passionate innovators who use science and technology to enrich people’s lives in Healthcare, Life Science, and Electronics. We dream big, and we care for our rich mix of people, customers, patients, and the planet. If you are a curious mind that sees yourself imagining the unimaginable, then you are the right fit for us. In this article, we will provide you with all the information you need to know about this exciting job opportunity.
Job Requisition ID: 263597
Location: Bangalore
Career Level: C – Professional (1-3 years)
Working time model: full-time
Job Description
The primary responsibilities of a Drug Safety Associate include performing timely data processing, ensuring data integrity and consistency, providing feedback on potential improvements, providing training on global case processing processes, supporting audits and inspection processes, and completing all mandatory HR4YOU training well within due dates.
Education
To qualify for this position, you need to have a medical or scientific background, an advanced level of written and spoken English, familiarity with English medical terminology, and solid professional skills.
Work Experience
A Drug Safety Associate should have 2 to 4 years of related experience in medical or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge, which should include 1 – 2 years in Drug Safety. In addition, good problem-solving skills are essential.
Technical / Functional Skills
The following are the technical and functional skills required for this position:
- 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, by the safety database and safety data processing and medical evaluation guidelines as well as SOP.
- Ensures integrity and consistency of data against source documents by performing QC and appropriate correction of all processed cases with inappropriate 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 in data entry and safety database system changes as well as additional training needs.
- Provides training on global case processing processes upon request.
- Ensures completion of all mandatory HR4YOU training well within due dates.
- Supports training the new joiners (Train and support on case processing and Sample QC process, provide feedback on cases processed).
- Supports audits and inspection processes.
Specific Skills
A Drug Safety Associate should have the following 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 include, advanced 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 a collaborative and supportive role.
- Excellent written and verbal communication skills.
What We Offer
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 their 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
FAQs
1. What are the primary responsibilities of a Drug Safety Associate?
The primary responsibilities of a Drug Safety Associate include performing timely data processing, ensuring data integrity and consistency, providing feedback on potential improvements, providing training on global case processing processes, supporting audits and inspection processes, and completing all mandatory HR4YOU training well within due dates.
