Accenture is a global professional services company with leading capabilities in digital, cloud and security. MPharm MSc QA job details are given below for you. Please refer the the same and apply now.
Skill required: Pharmacovigilance – Pharmacovigilance & Drug Safety Surveillance
Designation: Senior Quality Governance Scientist
Job Location: Bengaluru
Job summary :
You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings – Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. You will be part of a dynamic Pharmacovigilance team with array of capabilities ranging from detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem following Good Pharmacovigilance Practice (GVP) per client SOPs and applicable global regulatory requirements (Individual Case Safety Reports) to working on various aspects of Aggregate reports such as planning, authoring, reviewingÂ and publishing of PBRER, PSUR, DSUR, PADER, Addendum to clinical overview (AdCO), Risk Management Plan (RMP), Signal detection and validation reports (SDVR), Cosmetovigilance Safety Reports (CoSR). The Pharmacovigilance team is also responsible for authoring and reviewing clinical documents such Protocols and amendment, Investigator Brochure, Clinical Study Reports (CSR), Synoptic/Abbreviated CSR, Safety Narratives, Clinical Overview/abbreviated Clinical Overview. In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements.
Skills required for MPharm MSc QA job :
• Pharmacovigilance & Drug Safety Surveillance
• Quality Assurance (QA)
• Quality Management
• Ability to perform under pressure
• Ability to work well in a team
• Detail orientation
• Problem-solving skills
• Written and verbal communication
• Life Sciences
• In this role you are required to do analysis and solving of moderately complex problems
• May create new solutions, leveraging and, where needed, adapting existing methods and procedures
• The person would require an understanding of the strategic direction set by senior management as it relates to team goals
• Primary upward interaction is with the direct supervisor
• May interact with peers and/or management levels at a client and/or within Accenture
• Guidance would be provided when determining methods and procedures on new assignments
• Decisions made by you will often impact the team in which they reside
• Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture
• Please note that this role may require you to work in rotational shifts
Qualifications: Master of Pharmacy/MSc/P G Diploma In Clinical Research
Years of Experience: 7 to 11 years
You can go through the following interview questions and answers provided below. Apply for the MPharm MSc QA job before the last date. You can prepare well by practicing the following question and answers. All the best for your interview!!!
Question: Can you explain your experience in Pharmacovigilance and Drug Safety Surveillance, particularly with respect to Good Pharmacovigilance Practice (GVP) and global regulatory requirements?
Answer: Certainly. Over the past 7 to 11 years, I have been actively involved in Pharmacovigilance and Drug Safety Surveillance activities. I possess a comprehensive understanding of Good Pharmacovigilance Practice (GVP) guidelines and have consistently adhered to applicable global regulatory requirements. My experience includes the detection, assessment, understanding, and prevention of adverse effects related to medicines and vaccines, as well as the preparation and submission of Individual Case Safety Reports (ICSRs) in compliance with client SOPs and relevant regulations.
Question: How do you ensure the quality and accuracy of pharmacovigilance activities you perform, and how do you handle the pressure of managing complex problems?
Answer: As a Senior Quality Governance Scientist, I place significant emphasis on detail orientation and quality assurance in all aspects of pharmacovigilance work. I thoroughly review and verify data entry, MedDRA coding, case processing, and other related activities to ensure accuracy. To manage complex problems, I adopt a systematic and analytical approach, breaking down the issues into manageable components. I prioritize tasks and collaborate with team members to leverage existing methods and procedures, ensuring effective problem-solving under pressure.
Question: How do you maintain effective communication and collaboration within the pharmacovigilance team and with external stakeholders?
Answer: Communication and teamwork are crucial aspects of successful pharmacovigilance operations. I actively engage with team members, providing regular updates, sharing insights, and seeking input to foster a collaborative environment. Additionally, I maintain open lines of communication with clients and external stakeholders, ensuring that strategic directions and goals are well-understood and aligned. Effective communication helps facilitate smooth operations and ensures that all team members are on the same page.
Question: Can you describe your experience in authoring and reviewing clinical documents, such as Clinical Study Reports (CSR) and Safety Narratives?
Answer: I have considerable experience in authoring and reviewing various clinical documents, including Clinical Study Reports (CSR), Safety Narratives, Protocols, and Investigator Brochures. I have contributed to the planning, authoring, and review process of these documents, ensuring compliance with regulatory guidelines and standards. The ability to present complex medical information in a clear and concise manner is essential in this role, and I have honed this skill over the years.
Question: How do you stay updated with the latest developments and changes in the field of pharmacovigilance and drug safety?
Answer: I understand the importance of staying abreast of the latest advancements in pharmacovigilance and drug safety. To do so, I regularly attend industry conferences, webinars, and workshops. I am a member of professional organizations related to pharmacovigilance and drug safety, where I engage in discussions and knowledge-sharing with peers. Additionally, I follow relevant publications, regulatory updates, and guidelines to ensure compliance with the evolving landscape of pharmacovigilance practices.