Drug Safety Associate
2 weeks ago
Responsibilities:
- Receive and process adverse event reports from various sources, including healthcare professionals, consumers, and clinical trials.
- Conduct initial assessment of reported adverse events to determine seriousness, expectedness, and causality.
- Enter adverse event data into safety databases accurately and in a timely manner, ensuring compliance with regulatory requirements and internal procedures.
- Perform case processing activities, including narrative writing, coding, and follow-up with reporters for missing or incomplete information.
- Conduct literature searches to identify relevant safety information and contribute to signal detection activities.
- Assist in the preparation and submission of expedited and periodic safety reports to regulatory authorities.
- Participate in safety surveillance activities, including trend analysis and periodic safety reviews.
- Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, and other stakeholders to ensure timely and appropriate risk management strategies.
**Job Types**: Full-time, Fresher
**Salary**: ₹24,000.00 - ₹27,000.00 per month
**Benefits**:
- Health insurance
- Provident Fund
- Work from home
Schedule:
- Day shift
- Monday to Friday
**Experience**:
- total work: 1 year (preferred)
Work Location: Remote
**Speak with the employer**
+91 8237213453
-
Safety Writer
4 weeks ago
Remote, India Kateric Full time(India) **About Us** Kateric is a strategic partner for biopharmaceutical companies that consistently delivers superior quality regulatory documents through excellence, experience, and intelligent execution. Kateric’s resources are located across multiple time zones in the United States, as well as in India, the EU and Canada, and also have experience...
-
Principal Safety
5 days ago
Remote, India Syneos Health Clinical Full time**Description** **Principal Safety & Pharmacovigilance Specialist** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide...
-
Site Safety Officer
4 weeks ago
Remote, India UHP Technologies Pvt Ltd Full time**Experience: 3-5 years** The role of a Site Safety Officer is crucial in ensuring the well-being of workers and the compliance of the workplace with safety regulations.. **Salary - RS 22000/- to RS 25000/- per month** Person should know risk analysis, PPE inspection, JSA, TBT, method statemet, incident investigation and statutory laws about EHS. He must...
-
PV Information Specialist GPIO
3 weeks ago
REMOTE, India Parexel Full timeThe Pharmacovigilance Information Specialist (PVIS) for GPIO (Global Pharmacovigilance Information Office) will research, review, and maintain information related to expedited and periodic safety reporting requirements for both clinical trial studies and post market projects. The PVIS works to ensure company and client compliance with relevant national and...
-
Senior Medical Writer
2 weeks ago
REMOTE, India Parexel Full timeJob Purpose: Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United...
-
Junior Pharmacovigilance Associate
7 days ago
Remote, India Morningside Healthcare India Private Ltd Full timeWe are looking to recruit a Junior Pharmacovigilance Associate reporting to the Pharmacovigilance Manager **What will you be doing?** As the Junior Pharmacovigilance Associate, you will be responsible for a variety of different tasks including: - Play an active role within the Pharmacovigilance Team, accountable for monitoring and managing all aspects of...
-
Clinical Research Associate
4 weeks ago
Remote, India Rexo Solutions Full timeOur ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of...
-
Regulatory Medical Writer
4 weeks ago
Remote, India Kateric Full time(India) Looking for experienced regulatory writers **As we are expanding our team, we are thrilled to announce that we are looking for experienced Indian regulatory writers to join our dynamic, collaborative team to engage with biopharmaceutical clients and prepare clinical and safety regulatory documents. This is a full-time, remote, salaried...
-
Associate, QA
4 weeks ago
Remote, India Syneos Health Clinical Full time**Description** **Quality Assurance Associate** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...
-
Assoc Dir, Biostatistics
4 weeks ago
Remote, India Syneos Health Clinical Full time**Description** **Associate Director, Biostatistics** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to...
-
Medical Data Reviewer
2 weeks ago
Remote, India ICON Full timeICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What you will be doing**: Serve as a Clinical Data reviewer and identify any errors in data by...
-
Store Supervisor
5 days ago
Remote, India SM Career Builder Full time**Responsibilities**: - Supervise daily store operations to achieve sales goals and maximize profitability. - Train and develop sales associates to provide superior customer service and product knowledge. - Ensure compliance with company policies and procedures, including inventory management, cash handling, and safety protocols. - Implement effective...
-
Medical Writer 2
4 weeks ago
Remote, India IQVIA Full timeJob Overview Acts as Lead Medical Writer on more advanced writing projects (e.g. complex clinical study reports, protocols, more challenging indications, or customers). Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. May provide feedback to peers when...
-
118
4 weeks ago
Remote, India ProductLife Group Full time**Responsibilities**: - To contribute to the production of client administrative documents and reports to be included in regulatory submissions - Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements - LCM, Systems Management and Administration - Document and track regulatory submissions and regulatory...
-
Lighting Solutions Associate
5 days ago
Remote, India Ideolux Full time**About Ideolux** Ideolux is a leading LED Lighting company that designs, engineers, and produces high-quality LED lighting solutions. Our project-grade products, systems, and services comply with international quality and safety requirements. With a mission to streamline the supply chain and elevate quality standards, we continuously innovate using...
-
Healthcare Executive
7 days ago
Remote, India Pfizer Full timeWe are looking for experienced _ _ - women frontline sales professionals_ for taking on the biggest opportunity in Vaccines business of Pfizer India, and thus making a big patient impact. This individual will be responsible for driving sales results in Hospitals for Vaccines business and build long term client relations with KOLs. Location: Different...
-
Principal Stat Programmer
4 weeks ago
Remote, India Syneos Health Clinical Full time**Description** **Principal Statistical Programmer** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...
-
Periodic Reporting Expert
4 weeks ago
Remote, India IQVIA Full timeAccountable for PSR processes deployment. - Coordinate PSR preparation activities. Liaise with internal stakeholders and Shared INN PSR management - Provides Global PSR format training to new and contributors, provides mentorship for new PREs; - SME in inspections, internal and partner audits to communicate PSR processes and expectations as defined in...
-
Quality Control Auditor
4 weeks ago
Remote, India Indecomm Technology Services Full time**Job Brief**: Are you meticulous and detail-oriented professional with a passion for maintaining the highest standards? Indecomm invites you to be part of our team as a Quality Control Auditor, where you’ll play a pivotal role in ensuring loan production adheres to industry regulations and investor requirements. As a QC Auditor, you will conduct...
-
Project Coordinator
4 weeks ago
Remote, India Sphera Solutions Full timeSphera is a leading global provider of enterprise software and services that enables companies to manage and optimize their environmental, health, safety and sustainability. Our mission is to create a safer, more sustainable and productive world. Sphera is a portfolio company of Blackstone, a U.S.based alternative asset investment company that focuses on...