Accenture BSc Life Sciences With 0-1 Year Exp Can Apply For Pharmacovigilance Job

Accenture BSc Life Sciences With 0-1 Year Exp Can Apply For Pharmacovigilance Job

Accenture BSc Life Sciences With 0-1 Year Exp Can Apply For Pharmacovigilance Job. Accenture BSc life sciences job opening. Freshers life sciences job openings. BSc jobs. Accenture careers. Interested and eligible applicants can check out all of the details on the same below

Pharmacovigilance Services New Associate-Pharmacovigilance

Designation: Junior Drug Safety Associate

Job Location: Bengaluru

JOB NO. 278152

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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.

Job Description

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. 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.

What are we looking for?

• Life Sciences
• Adaptable and flexible
• Ability to perform under pressure
• Agility for quick learning
• Commitment to quality
• Written and verbal communication
• Clinical Data Management

Roles and Responsibilities

• In this role you are required to Analyse the medical records and dataentry, solve routine problems, largely through precedent and referral to general guidelines
• Your primary interaction is within your own team and your direct supervisor
• In this role you will be given detailed instructions to prioritize the cases ontime with expected quality.
• The decisions that you make impact your own work and are closely supervised
• You will be an individual contributor as a part of a team with a predetermined, narrow scope of work
• Please note that this role may require you to work in rotational shifts

Skill required: Pharmacovigilance – Pharmacovigilance & Drug Safety Surveillance

Qualifications: BSc

Years of Experience: 0 to 1 years.

APPLY ONLINE

Possible Interview Questions:

1. Can you explain what pharmacovigilance is and its importance in the life sciences industry? Answer: Pharmacovigilance is the process of detecting, assessing, understanding, and preventing adverse effects or any other medicine/vaccine-related problems. It plays a crucial role in ensuring patient safety and helps in monitoring the safety profile of pharmaceutical products throughout their lifecycle.
2. How do you ensure compliance with Good Pharmacovigilance Practice (GVP) and global regulatory requirements when handling Individual Case Safety Reports (ICSRs)? Answer: Compliance with GVP and global regulatory requirements is ensured by following client-specific Standard Operating Procedures (SOPs) and relevant guidelines. This includes proper case processing, data entry, MedDRA coding, and timely submission of ICSRs in the safety database.
3. What experience do you have in working with Aggregate reports, and can you explain the process of planning, authoring, reviewing, and publishing PBRER, PSUR, DSUR, PADER, and other related reports? Answer: I have experience in working with Aggregate reports, which involve analyzing safety data from multiple sources and synthesizing the information into comprehensive reports. The process includes planning the report, authoring it by collating relevant data, reviewing it for accuracy, and finally publishing it for regulatory submission.
4. How do you handle clinical documents such as Protocols, Investigator Brochure, and Clinical Study Reports (CSRs) in the pharmacovigilance process? Answer: Handling clinical documents requires attention to detail and adherence to guidelines. I am involved in authoring and reviewing Protocols, Investigator Brochures, CSRs, Safety Narratives, and other related documents, ensuring they meet the required standards and are accurate.
5. Describe a situation where you had to work under pressure to meet deadlines in a pharmacovigilance project, and how did you handle it? Answer: In a previous pharmacovigilance project, we had a tight deadline for submitting safety reports. To manage the pressure, I prioritized tasks, communicated effectively with team members to ensure smooth collaboration, and worked diligently to meet the deadline without compromising on quality.

Note: The answers provided above are indicative and should be tailored to the candidate’s actual experience and knowledge.

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