Pharmacy Drug Safety Job – Accenture – Apply Online
Accenture hiring, B Pharmacy job opening 2023, M Pharmacy job opening 2023, Pharmacovigilance job opening 2023, Pharma job opening 2023, Pharmacy job opening 2023, Intrested and eligible candidates may check out all the details on the same below:
Skill required: Pharmacovigilance – Pharmacovigilance & Drug Safety Surveillance
Job Title: Bus Process Delivery Associate
Job Location: Bengaluru
Qualifications: BSc/Bachelor of Pharmacy/Master of Pharmacy
Years of Experience: 1 to 3 years
What would you do?
- 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, reviewing 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. Responsible for the evaluation and processing of Adverse Events in the Global Safety Database within agreed timeframes and to a high standard of accuracy, in compliance with standard operating procedures and global regulatory requirements.
What are we looking for?
• Ability to work well in a team
• Adaptable and flexible
• Agility for quick learning
• Commitment to quality
• Detail orientation Educational and Experience Requirements:
• Minimum of Bachelor’s degree in Health Sciences; Bachelor’s Degree in Life Science with relevant Pharmacovigilance experience
• A minimum of 1 years’ experience in pharmaceutical or clinical research preferred.
• Knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug
• Good medical writing skills
• Good Communication Skills
• Analytical Ability
• Strong English Language proficiency
Roles and Responsibilities
Responsibilities/Authorities
• Prioritise case processing activities for ICSRs in accordance with project guidelines, Regulatory due date and TAT SLAs and KPIs.
• Processing and evaluation of Individual Case Safety Reports
• Consistent data entry and processing from source documents, adhering to timelines and quality.
• Confirm accurate and consistent coding of medical history, drugs and adverse event terms.
• Assess adverse event reports for seriousness, causality and expectedness as per applicable labeling, consulting the Medical Reviewer whenever needed.
• Alert the Medical Reviewer of potential safety issues and assist the Medical Reviewer in monitoring the safety profile of product as appropriate.
• Determine if any additional information is needed for clarification, or if any follow-up is necessary, and take all relevant steps to obtain any additional/missing information as stated in the relevant Project SOP.
• Archive all communications/clarifications related to the Case in the Global Safety Database.
• Initiate and handle case deletions/ nullification as appropriate.
• To participate in audits or inspections.
• Open to get trained and moved across roles based on business requirement.
• Training and mentoring to new associates.
• Authoring of process documents.
Apply Online
Possible Interview Questions:
Can you provide an overview of your experience and knowledge in pharmacovigilance and drug safety surveillance?
Answer: Certainly! I have a Bachelor’s degree in Pharmacy and I have been working in the field of pharmacovigilance for the past two years. I am well-versed in the processes and practices involved in the detection, assessment, understanding, and prevention of adverse effects related to medicines. I have experience in working with Individual Case Safety Reports, as well as handling aggregate reports such as PBRER, PSUR, DSUR, and PADER. Additionally, I have knowledge of medical terminologies, including MedDRA and WHO-Drug.
How do you prioritize case processing activities for Individual Case Safety Reports (ICSRs) while adhering to project guidelines and timelines?
Answer: Prioritization is key when it comes to case processing activities for ICSRs. I evaluate the urgency and regulatory due dates of the cases, ensuring compliance with project guidelines, TAT SLAs, and KPIs. I assess the seriousness, causality, and expectedness of adverse events as per applicable labeling. If there are any safety concerns, I promptly escalate them to the Medical Reviewer. Additionally, I maintain accurate and consistent data entry from source documents to ensure timely and high-quality processing.
How do you ensure the accuracy and consistency of coding medical history, drugs, and adverse event terms in pharmacovigilance?
Answer: Accuracy and consistency are essential in coding medical history, drugs, and adverse event terms. I pay close attention to detail and follow standardized coding dictionaries such as MedDRA and WHO-Drug. I verify the information from source documents and ensure precise and consistent coding to enable proper analysis and reporting. If there are any ambiguities or uncertainties, I consult with relevant resources and seek clarification to ensure accurate coding.
Can you describe your experience in collaborating with medical reviewers and contributing to the monitoring of product safety profiles?
Answer: Collaboration with medical reviewers is vital in pharmacovigilance. I have worked closely with medical reviewers to assess the seriousness, causality, and expectedness of adverse events. I have effectively communicated potential safety issues and provided necessary information to support the monitoring of product safety profiles. This collaboration ensures a comprehensive evaluation of adverse events and helps in making informed decisions regarding product safety.
How do you maintain compliance with standard operating procedures (SOPs) and global regulatory requirements in pharmacovigilance?
Answer: Compliance with SOPs and global regulatory requirements is crucial in pharmacovigilance. I ensure that my work aligns with established SOPs, adhering to the specific guidelines and protocols. I stay updated with the latest regulatory requirements and guidelines, such as those set by regulatory authorities. Regular training and continuous learning help me stay informed and maintain compliance. I am diligent in documenting all relevant information and communications in the Global Safety Database to ensure traceability and compliance during audits or inspections.
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