Pharmacovigilance Specialist Vacancy @ Teva – Apply Online
Dont forget to check out possible interview questions for this job below
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Job Title: Pharmacovigilance Specialist II
Location: Bangalore, India, 560064
Eligbility Criteria & Experience:
- Minimum Bachelor’s degree in Pharmacy or another related field.
- Knowledge and understanding of relevant GxP requirements applicable for position
- Knowledge of pharmacovigilance principles and international regulatory requirements related to drug and patient safety.
- Basic knowledge on TEVA product portfolio, their therapeutic areas expertise, mechanism of actions and its product/patient safety index.
- Fluent in English.
The Pharmacovigilance Assistant/ Pharmacovigilance Specialist II, Global PSO will interface with internal and external stakeholders to ensure the collection of individual case safety reports (ICSRs), communicates with local pharmacovigilance officers, business partners, global Data Management Units, to ensure compliance with standard operating procedures, pharmacovigilance agreements and global requirements.
How you’ll spend your day
- Administrative Support for PV India unit to ensure smooth functioning; this includes co-ordination with various departments (facilities, Security, IT and HR)
- Knowledge of purchase order creation and processing
- Basic understanding of pharmacovigilance individual case processing activities.
- Monitoring Safety Data Management Unit India mailbox
- Processing initial information of safety adverse events reports into global PV database:
- Daily cases assignment to the case owners for case processing into global database
- Tracking, filing and archiving incoming safety information
- Respond to reconciliation queries to identify and resolve discrepancies and ensure all reconciliation activities are completed within the procedural timeframes
- Organize and schedule team calls and meetings; assist with meeting minutes
Possible Interview Questions:
- Can you explain your understanding of pharmacovigilance and its importance in the pharmaceutical industry?
- Answer: Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a crucial role in ensuring the safety of patients using pharmaceutical products. Monitoring and analyzing adverse event reports, conducting risk assessments, and implementing risk minimization strategies are some of the key responsibilities of pharmacovigilance professionals.
- How do you stay updated with the relevant GxP requirements and international regulatory guidelines in pharmacovigilance?
- Answer: As a pharmacovigilance specialist, I actively participate in training programs, attend conferences, and engage in continuous learning to stay up-to-date with the evolving GxP requirements and international regulatory guidelines. I also regularly review scientific literature, publications, and guidelines from regulatory authorities to ensure compliance and best practices in pharmacovigilance.
- Can you describe your experience in handling individual case safety reports (ICSRs) and collaborating with various stakeholders?
- Answer: In my previous role, I had the opportunity to handle ICSRs and collaborate with multiple stakeholders, including local pharmacovigilance officers, business partners, and global Data Management Units. I ensured compliance with standard operating procedures, pharmacovigilance agreements, and global requirements throughout the case processing lifecycle. Effective communication, attention to detail, and adherence to timelines were key aspects of my role.
- How would you handle discrepancies or reconciliation queries in the processing of adverse event reports?
- Answer: When encountering discrepancies or reconciliation queries, I would thoroughly review the available information and compare it with relevant data sources. I would communicate with the stakeholders involved, seek clarification if needed, and work towards resolving the discrepancies within the procedural timeframes. Attention to detail, effective communication skills, and a systematic approach are crucial in ensuring accurate and reliable data reconciliation.
- Can you share an example of a challenging situation you faced in pharmacovigilance and how you resolved it?
- Answer: In my previous role, we encountered a sudden increase in adverse event reports for a specific product. To effectively manage the situation, I collaborated with the team to streamline the case processing workflow, prioritize urgent cases, and ensure timely reporting to regulatory authorities. Additionally, I conducted a root cause analysis to identify potential reasons behind the increase and implemented proactive measures to mitigate any future issues. This experience enhanced my problem-solving skills and reinforced the importance of adaptability and teamwork in pharmacovigilance.
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