Accenture Hiring Pharmacovigilance Services Senior Analyst
Pharmacovigilance Services Senior Analyst Post for B Pharma candidates at Accenture. Interested candidates can check out the details below and Apply Online.
Job Title: Pharmacovigilance Services Senior Analyst
Job Id: 271541
Skill required: Pharmacovigilance – Pharmacovigilance & Drug Safety Surveillance
Job Location: Bengaluru
Educational Qualifications: Bachelor of Pharmacy
Required Experience: 5 – 8 Years
About Accenture
Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries.
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. Perform quality checks and related activities on approved ICSRs as per client specifications/ or approved score cards. Also provide training as per requirements and contribute toward deal compliance
What are they 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 2 years of experience in Pharmacovigilance required.
- Thorough knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug
- Good Communication Skills
- Analytical Ability
- Technology skills: experience with MS office, knowledge of safety database
- Automation technology as applicable for the role
- Strong English Language proficiency (Reading and Writing)
- Good English Language proficiency (Listening and Speaking)
Roles and Responsibilities
- Implement Quality Checks steps on all its processes and procedures during the execution of the Services in order to provide quality Services to Client.
- Review overall quality of the ICSR case, including the completeness of the information, accuracy of the data entered, and appropriateness of the causality assessment.
- focus on the locked cases from the previous daily, by taking random samples for Quality review. All the sampled cases should be reviewed within the agreed timelines.
- Document the detected errors and perform root cause analysis.
- communicate observations (potential errors) identified during quality check of the case to the individual involved in processing of case via email.
- To mentor and train new hires or other associates.
- Open to get trained and move across roles based on business requirement.
- Supports audits and inspections, develop corrective/preventive action plans
- Authoring of process documents
- Escalate issues or tasks outside the normal scope of work.
Possible interview questions and answers for Pharmacovigilance Services Senior Analyst Position.
- Question: What is your experience with pharmacovigilance processes and regulations?
Answer: I have been working in the field of pharmacovigilance for the past six years, specifically focusing on drug safety surveillance and adverse event reporting. I am familiar with the pharmacovigilance guidelines and regulations, including Good Pharmacovigilance Practice (GVP) and global regulatory requirements. My experience includes working on individual case safety reports (ICSRs), aggregate reports, signal detection, risk management plans, and clinical documentation.
- Question: How do you ensure quality in pharmacovigilance processes?
Answer: Quality is of utmost importance in pharmacovigilance to ensure patient safety and regulatory compliance. I implement quality checks at every step of the process, reviewing the completeness and accuracy of information in ICSRs, assessing causality appropriately, and conducting root cause analysis for any detected errors. I communicate observations and provide feedback to the team members involved in processing the cases. I also participate in audits and inspections and contribute to the development of corrective and preventive action plans.
- Question: How do you handle training and mentoring responsibilities?
Answer: As a senior analyst, I take training and mentoring responsibilities seriously. I have experience in training new hires and providing guidance to other associates. I believe in a hands-on approach, providing comprehensive training on pharmacovigilance processes, safety databases, and relevant medical terminologies. I am patient and approachable, ensuring that the trainees understand the concepts and can effectively perform their responsibilities. I also encourage continuous learning and growth within the team.
- Question: How do you stay updated with the latest developments in pharmacovigilance?
Answer: Pharmacovigilance is a rapidly evolving field, and it is essential to stay updated with the latest developments and regulatory changes. I actively engage in professional development activities, such as attending conferences, webinars, and workshops related to pharmacovigilance. I also participate in relevant forums and discussion groups to exchange knowledge and insights with industry peers. Additionally, I regularly review scientific literature, regulatory guidelines, and industry publications to stay informed about emerging trends and best practices.
- Question: How do you handle tasks outside the normal scope of work or unexpected challenges?
Answer: I believe in being adaptable and flexible in the workplace. If I encounter tasks or challenges that fall outside my normal scope of work, I approach them with a proactive mindset. I assess the requirements, seek guidance or support from colleagues or subject matter experts, and quickly learn the necessary skills to complete the task effectively. I am comfortable working in a dynamic environment and can prioritize tasks to ensure that deadlines are met without compromising quality.
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