As a Safety Aggregate Report Specialist 2, you will play a key role in ensuring compliance with global pharmacovigilance regulations by authoring, reviewing, and managing high-quality aggregate safety reports (ASRs) such as Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Periodic Benefit-Risk Evaluation Reports (PBRERs).
You will collaborate cross-functionally with clinical, regulatory, and safety teams to ensure timely submission of regulatory reports in accordance with ICH and local requirements. Bachelors or Masters degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or related field.

3 8 years of experience in pharmacovigilance or aggregate report authoring.

Strong understanding of global regulatory guidelines (ICH, EMA, FDA, MHRA, etc.).

Excellent writing, analytical, and interpretation skills for clinical and safety data.

Familiarity with MedDRA coding, Argus/ARISg, and safety databases is preferred.

Biocon is seeking an experienced and detail-oriented Drug Safety Physician to join our Global Pharmacovigilance team. The ideal candidate will be responsible for evaluating drug safety data, conducting medical review of adverse event reports, and ensuring compliance with global regulatory safety requirements. This role plays a critical part in maintaining patient safety and supporting the benefit-risk assessment of Biocons products. Perform medical review and assessment of individual case safety reports (ICSRs) from clinical trials and post-marketing sources.

Provide medical expertise in signal detection, risk management, and safety data analysis.

Author and review aggregate safety reports (PSURs, PBRERs, DSURs) in accordance with global guidelines.

Contribute to the development and maintenance of Risk Management Plans (RMPs).

Collaborate with cross-functional teams including clinical, regulatory, and quality assurance.

Participate in safety signal evaluation and risk-benefit assessments.

Ensure all pharmacovigilance activities are compliant with global regulations (FDA, EMA, CDSCO). MBBS / MD (Pharmacology, Internal Medicine, or related specialty) is required.

26 years of experience in Pharmacovigilance, Drug Safety, or Clinical Research.

In-depth understanding of ICH, GVP, and global PV regulations.

Strong analytical, decision-making, and communication skills.

Experience with safety databases (e.g., Argus, ARISg) preferred.

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 worlds 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.Visit us at www.accenture.com. What are we looking for Adaptable and flexibleAbility to perform under pressureWritten and verbal communicationMICC experience and ready to work in any shift
Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts
Qualifications:
Bachelor of Pharmacy,Master of Pharmacy.

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent thats bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.Careers.Indegene.Com Looking to jump-start your career We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegenes high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Job Overview
Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Data Management (DM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; Overview of financial management for data management activities; communications; and milestone deliverables. Perform role of Data Team Lead (DTL).

Essential Functions
Gather Study Set up requirements through discussion and communication with relevant stakeholders.
With Minimal guidance - support, overview of validation of new Device integrations.
Oversight & Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor.
Ensure that all the deliverables are of expected quality standards and meet customer expectations.
With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW).
Support Training of New joiners.
Lead internal study meetings and internal/ sponsor audits and participate in Study Kick off meetings and other sponsor meetings.
Tracks and manages the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended as required.
With Guidance manage & oversight the implementation of new technology / database revisions.
Work closely with the programming team for process innovation and automation.
Be compliant to trainings and eSOP reading.
Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
Communication with Line Manager, and other team members across functions should be collaborative.
Perform other duties as directed by Line Manager.

Qualifications
Bachelor's Degree Bachelor Pharmacy or equivalent Pref
3 -4 years direct Data Management experience, including a minimum of 1 year as a CDM project lead. Pref
English Fluency Spoken and English Advanced
Advanced computer applications like Microsoft excel, word, Inbox etc Advanced
Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process Advanced.

Medical Coding is the process of converting Verbal Descriptions into numeric or alpha numeric by using ICD 10-CM, CPT & HCPCS. As per HIPAA rules healthcare providers need efficient Medical Coders.

Qualification & Specifications :

MBBS, BDS, BHMS, BAMS, BSMS, PHARMACY B.Sc/M.Sc (Life Sciences / Biology / Bio Chemistry / Micro Biology / Nursing / Bio Technology), B.P.T, B.E BIOMEDIAL, B.Tech (Biotechnology/Bio Chemistry).

2020 -2024 passed out

Skills Required:

* Candidates should have Good Communication & Analytical Skills and should be Good at Medical Terminology (Physiology & Anatomy).

Role:

To review US medical records
Initial file review for identifying merits
Subjective review and analysis to identify instances of negligence, factors contributing to it
To review surgical procedures, pre and post-surgical care, nursing home negligence
To prepare medical submissions
To prepare the medical malpractice case.

Job description
Looking for a motivated individual to join our team as a Trainee Medical Reviewer in Bengaluru. The ideal candidate should have 0-1 years of experience.

Roles and Responsibility
Conduct thorough medical reviews of patient records and reports.
Analyze data to identify trends and patterns, providing insights for informed decision-making.
Collaborate with healthcare professionals to develop effective treatment plans.
Stay updated on the latest medical research and developments.
Maintain accurate and detailed records of review findings and recommendations.
Participate in quality improvement initiatives to enhance processes and outcomes.
Job Requirements
Strong understanding of medical terminology and concepts.
Excellent analytical and problem-solving skills.
Ability to work effectively in a fast-paced environment with multiple priorities.
Effective communication and interpersonal skills.
Strong attention to detail and organizational skills.
Ability to maintain confidentiality and handle sensitive information.
A graduate or postgraduate degree is required.

Specializes in diagnosing and treating hormonal and endocrine disorders such as diabetes, thyroid diseases, and adrenal conditions. Conducts diagnostic tests, develops treatment plans, and monitors patient progress. Works with patients to manage chronic endocrine conditions and improve overall health outcomes.

Diagnoses and treats neurological disorders such as epilepsy, Parkinsons disease, and multiple sclerosis. Performs neurological assessments, develops treatment plans, and provides ongoing care for patients with neurological conditions. Works with other specialists to manage complex cases and improve patient quality of life.

Diagnoses and treats cardiovascular conditions such as heart disease, hypertension, and arrhythmias. Performs and interprets diagnostic tests, develops treatment plans, and provides ongoing care for patients with heart conditions. Works closely with other healthcare professionals to manage and improve patient outcomes related to cardiovascular health.