Sitero Senior Drug Safety Associate Opportunity, Apply Online
Sitero Senior Drug Safety Associate Opportunity, Apply Online. Sitero Mysore Senior Drug Safety Associate job opening. Interested and eligible applicants can check out all of the details on the same below
Hey, are you a french speaking individual from a life sciences background and interested in this Senior Drug Safety Associate – MICC at Sitero? Then check out all of the possible interview questions and the answers below
Senior Drug Safety Associate – Medical Information Call Centre (French Speaking)
Drug Safety Services · Mysore, Karnataka
Senior Drug Safety Associate – Medical Information Call Centre (MICC)
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
Job Title: Senior Drug Safety Associate – MICC
Location: Mysore – Hybird
Function: Drug Safety Services
DESCRIPTION:
Senior Drug Safety Associate MICC is a safety professional responsible for assessing the safety of pharmaceutical drugs undergoing clinical trials or once they are in the market. Using standard guidelines, they determine whether the medication causes any adverse reactions in patients and report their findings back to regulatory bodies and health authorities.
The individual will be an integral part of a group of safety professionals within Sitero and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Experience in managing calls from patients across US, Canada and Europe
- Competency with medical and therapeutic terminology
- Able to perform calls for follow up queries, discuss about product information as needed
- Understand the requirements of callers and provide precise information
- Manage product specific inquiries/medical inquires , product complaints, AE/SAE calls as needed
- Perform case processing and medical coding of ICSR’s as needed
- Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines
- Contributes to safety and pharmacovigilance training programs.
- Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community.
- Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
- Training and mentoring of Pharmacovigilance Associates on MICC as needed
EDUCATION AND EXPERIENCE REQUIRED:
- Minimum 2+ years of experience in drug safety as a part of the Medical Information Call Centre Team (MICC)
- Fluent in the FRENCH language
- Degree in Life Science/Pharma or Equivalents
PREFERRED SKILLS:
- 2-4 year of experience in drug safety, MICC
- Proficient in English and French
- Awareness of Safety database, Scientific coding browser: MedDRA, WHO etc
- In depth Knowledge and understanding of Drug Safety/Pharmacovigilance regulations with respect to pharmaceutical drugs and other related products
- Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment).
- Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders.
- Excellent verbal, written and presentation skills.
- Innovative, collaborative, initiative-taker.
COMPENSATION & BENEFITS:
Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.
EMPLOYMENT TYPE:
Full Time, Permanent
COMMITMENTS:
- Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.
- Willing to work in shifts as and when needed.
DISCLAIMER:
Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
Hey, are you a french speaking individual from a life sciences background and interested in this Senior Drug Safety Associate – MICC at Sitero? Then check out all of the possible interview questions and the answers below
- Can you describe your experience working in a Medical Information Call Centre (MICC)?
Answer: Yes, I have over 2 years of experience working in a MICC, managing calls from patients across US, Canada, and Europe. I am competent with medical and therapeutic terminology, and I can perform calls for follow-up queries and discuss product information as needed.
- How do you stay updated with drug safety and pharmacovigilance regulations and practices?
Answer: I maintain my medical knowledge as required by the role and keep up-to-date with the latest drug safety and pharmacovigilance regulations, practices, and risk-management practices. I attend training programs, read relevant publications, and collaborate with my colleagues to share knowledge.
- Can you explain the process of end-to-end case processing of Individual case safety reports (ICSRs)?
Answer: The process of end-to-end case processing of ICSRs involves receiving a case report, triaging, medical assessment, data entry, medical coding, quality control, and finally, reporting to regulatory agencies within the specified timelines.
- How do you manage product-specific inquiries, medical inquiries, product complaints, and AE/SAE calls from patients?
Answer: I understand the requirements of callers and provide precise information, manage product-specific inquiries, medical inquiries, product complaints, and AE/SAE calls as needed. I perform case processing and medical coding of ICSRs as needed and collaborate with the Regulatory Affairs team to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies.
- How do you mentor and train Pharmacovigilance Associates on MICC?
Answer: I train and mentor Pharmacovigilance Associates on MICC by sharing my knowledge and experience in drug safety, pharmacovigilance regulations, and practices. I provide feedback on their work, support them in their roles, and encourage their professional development.
Note: These are sample questions and answers. The interview questions and answers may vary based on the interviewer’s preference and job requirements.
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