Pharmacovigilance

**Key Responsibilities**: **1. Strategic Growth Development**: Identify, evaluate, and pursue new business opportunities in the pharmacovigilance domain, including AI-powered solutions. Develop and implement strategies to expand the company’s market presence and client portfolio. **2. Client Engagement**: Build and maintain long-term relationships with...

Job Summary **Designation**: GM - Pharmacovigilance (ICSR) **No. of Position**: 1 **Experience Range**: 12 to 15 years **Reporting to**: VP - Pharmacovigilance **Qualification**: A graduate degree/post graduate degree in pharmaceutical sciences/Life Sciences/Medical Science pref MBBS/MD. **Job Location**: Ahmedabad **Offered CTC**:...

Responsible for the evaluation & quality check of Individual Case Safety Reports (ICSR), and writing aggregated safety reports within agreed timeframes and to a high standard of accuracy, in compliance with DS&E business rules, standard operating procedures and global regulatory requirements. 1. Assess seriousness, causality and labeling of serious adverse...

At the forefront of pharmaceutical excellence, we pride ourselves on delivering comprehensive clinical research services to the industry. Our specialty lies in supporting pharmaceutical, biotechnology, medical device, and nutraceutical companies throughout every stage of the drug/product development lifecycle.Key Responsibilities:• Maintain and organize a...

**Designation - Signal Detection and Management** - 1. Assist the Signal Management Lead to develop the new signal detection process and changes to the signal tracking tool. - 2. Assess currently utilized quality documents and develop/modify business processes as needed. - 3. Develop training materials and provide training. - 4. Develop and implement a...

Job Title: Regulatory Affairs Specialist - PharmacovigilanceAbout the RoleThis is an exciting opportunity to join our team as a Regulatory Affairs Specialist - Pharmacovigilance, where you will be responsible for ensuring compliance with regulatory requirements and coordinating submissions to relevant authorities.Key ResponsibilitiesPSUR and ACO Scheduling:...

**Job Details**: - **Open Positions**: 2 - **Designation**: Pharmacovigilance Associate (Fresher) - **Location**: Novumgen Corporate Office, Vadodara - **Salary**: ₹15,000 per month **Key Responsibilities**: - Literature Monitoring - Track/review literature hits, maintain weekly matrix, reconcile data - Literature Screening - Screen/evaluate articles,...

Role & responsibilitiesLead, mentor, and manage the Pharmacovigilance QA team to ensure effective execution of QA activities.Develop, implement, and maintain QA processes, procedures, and tools aligned with regulatory guidelines (e.g., ICH, FDA, EMA).Monitor and ensure compliance of pharmacovigilance activities with applicable regulations and internal...

• Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR forsubmission to local and other Health Authorities.Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities

Role & responsibilitiesContributing to maintain or improve quality performance and compliance of operational PV activitiesEnsuring Deviation and CAPA Management, Change Control, Document Control, and other Quality Management System activitiesDeveloping, managing, and executing quality management processes to ensure quality standards are maintained and...