258 Drug Safety Associate jobs in India

Detailed Job Role:

• Monitor and document drug safety data, perform adverse event reporting, assist with pharmacovigilance and risk management.

KRA (Key Responsibility Areas):

• Case assessment, adverse event documentation, timely reporting, risk communication

KPI (Key Performance Indicators):

• Event processing time, report accuracy, submission regularity, follow-up efficiency

Job description:

• Job Summary:We are seeking a meticulous Drug Safety Associate to monitor, document, and manage drug safety data while supporting pharmacovigilance and risk management activities.
• The ideal candidate will ensure timely and accurate reporting of adverse events, contributing to patient safety and regulatory compliance.Key Responsibilities:
• Monitor, collect, and document adverse event data from clinical trials or post-marketing sources
• Perform case assessments and determine seriousness, causality, and expectedness of adverse events
• Prepare and submit timely safety reports to regulatory authorities
• Assist in pharmacovigilance activities, including risk management plans and safety signal detection
• Communicate safety information to relevant stakeholders and follow up on outstanding cases
• Maintain compliance with local and international regulatory requirements (GVP, ICH-GCP)

Key Performance Indicators (KPIs):

• Timeliness of case processing and report submissions
• Accuracy and completeness of adverse event documentation
• Regularity and compliance of regulatory submissions
• Efficiency of follow-ups on safety cases

Skills & Competencies:

• Strong knowledge of pharmacovigilance guidelines and regulations (GVP, ICH, FDA, EMA)
• Attention to detail and analytical skills Effective communication and documentation skills
• Ability to manage multiple cases simultaneously
• Proficiency in safety databases (eg, Argus, ARISg) and MS Office )

Date: 2 Sept 2025

Location:Bangalore, KA, IN

Job Description

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 that's 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 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 Indegene's high-speed growth. We are purpose-driven. We enable healthcare organizations to 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.

Must Have

Associate - Pharmacovigilance Officer I You will be responsible for: "Confirm validity of case by identifying minimum criteria for case creation. � Perform duplicate search to create either an initial case or a follow-up case. � Understanding the principles and concepts associated with patient safety case-handling process including regulatory requirements for reporting individual case safety reports. � Identify serious adverse events and special scenario cases which includes lack of efficacy, exposure, and pregnancy case, at risk cases, and product quality complaint only cases. � Attach the relevant source documents or any safety information/queries/follow-up information that is relevant to the case. � Facilitate follow-up based on queries from Data entry/QC/MR or based on inconsistent/missing information in the source file. Responsible for coding which includes adverse event, medical history, Lab data, Indications etc using standardized terminology from a medical coding dictionary, such as MedDRA. � Code products (Suspect/co-suspect, Concomitant) as per Client conventions and Regulatory requirements. � Draft narratives." Your impact: About you: (Desired profile) Must have: Understand the principles and concepts associated with case-handling process and overall Drug Research Process. � Cognitive abilities including verbal reasoning, attention to detail, and critical and analytical thinking. � Good knowledge on therapy area/medical terminology. � Good comprehension skills. � Good communication (verbal and written), with fluency in English and interpersonal skills. Nice to have: (Additional desired qualities) Perks: (Mention if any, otherwise ignore) EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate�s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate's merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

We are seeking a highly motivated and detail-oriented recent graduate to join our Drug Safety team as an Entry-Level Drug Safety Associate. This is an excellent opportunity to launch your career in the pharmaceutical industry and contribute to the safety surveillance of our products. You will gain practical experience in various aspects of drug safety, including adverse event processing, data entry, and safety reporting. This role is perfect for individuals with a strong interest in drug safety and a desire to learn and grow in a fast-paced environment.

Responsibilities:

• Adverse Event Case Processing:

• Receive, triage, and accurately enter adverse event reports into the drug safety database.

• Ensure timely and accurate data entry in compliance with company Standard Operating Procedures (SOPs) and regulatory guidelines.
• Assist in the follow-up of adverse event reports to obtain complete and accurate information.

• Perform quality control checks on case data to ensure accuracy and consistency.

• Data Management and Safety Reporting:

• Assist in the preparation of safety reports and data summaries.

• Maintain accurate and organized drug safety records.
• Assist in the tracking and monitoring of adverse event trends.

• Learn to identify and escalate potential safety signals.

• Regulatory Compliance:

• Develop a basic understanding of global drug safety regulations and guidelines (e.g., ICH guidelines).

• Adhere to company SOPs and regulatory requirements.

• Assist in the preparation of regulatory submissions.

• General Support:

• Assist in the maintenance of drug safety databases and systems.

• Participate in team meetings and training sessions.
• Support senior drug safety staff as needed.
• Perform other duties as assigned.

Qualifications:

• Bachelor's degree in Pharmacy, Pharmacology, Life Sciences, Nursing, or a related healthcare field.
• Strong interest in drug safety and pharmacovigilance.
• Excellent attention to detail and accuracy.
• Strong organizational and time-management skills.
• Ability to work independently and collaboratively within a team.
• Good communication and interpersonal skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Must be a recent graduate.

Preferred Qualifications (but not required):

• Basic understanding of medical terminology.
• Familiarity with drug safety databases or systems.
• Coursework related to pharmacology or drug safety.

Title: Drug Safety Associate

Bangalore, KA, IN

Job Description

Must Have

Good to have

EQUAL OPPORTUNITY

Title: Drug Safety Associate

Pune, MH, IN

Job Description

Must Have

Good to have

EQUAL OPPORTUNITY

• Process and evaluate adverse event reports from all sources, ensuring accuracy and completeness.
• Ensure compliance with global regulatory requirements for pharmacovigilance reporting.
• Conduct thorough medical review of adverse event cases and assess seriousness and causality.
• Prepare and submit aggregate safety reports (e.g., DSURs, PBRERs) to regulatory authorities.
• Identify potential safety signals and contribute to signal detection activities.
• Collaborate with internal departments (Medical Affairs, Regulatory Affairs, Clinical Operations) on safety-related matters.
• Contribute to the development and implementation of risk management plans (RMPs).
• Maintain and update drug safety databases, ensuring data integrity.
• Train and mentor junior drug safety associates.
• Participate in audits and inspections related to pharmacovigilance activities.

• Bachelor's or Master's degree in Pharmacy, Nursing, Medicine, or a related healthcare field.
• Minimum of 7 years of experience in pharmacovigilance or drug safety.
• In-depth knowledge of global regulatory requirements (e.g., FDA, EMA, CIOMS) for adverse event reporting.
• Proven experience in case processing, medical assessment of adverse events, and aggregate reporting.
• Proficiency with pharmacovigilance databases (e.g., Argus Safety, ArisG) and electronic reporting tools.
• Strong analytical, critical thinking, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work independently and manage multiple priorities effectively.

Title: Junior Drug safety associate

Bangalore, KA, IN

Job Description

Must Have

Good to have

EQUAL OPPORTUNITY

Hiring for Clinical Safety Physician in Mumbai, Bangalore & Noida

Any MBBS/MD with min 5 yrs of relevant Exp in Drug Safety, ICSR, Aggregate reporting, Clinical Study

Salary up to 25 LPA

Call Suhani , Rukhsar , Shruti