
Pharmacovigilance
3 days ago
**Duties & Responsibilities**:
1. Establishment and Maintenance of the Clients’ Pharmacovigilance system for the products (PSMF);
2. Have an overview of medicinal product safety profiles and any emerging safety concerns, if possible;
3. Maintain awareness of Pharmacovigilance regulatory requirements and developments; 4. Identify, collect and report adverse events (ADRs, SAEs, SARs, SUSARs);
5. Ensure the conduct of pharmacovigilance activities and the submission of all pharmacovigilance-related documents (e.g. ISCRS, SUSARs, DSURs RMPs) is in accordance with the legal requirements and GVP;
6. Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals);
7. Read and acknowledge all necessary Company standard operating procedures (SOPs) and customer SOPs as required;
8. Creation and maintenance of pharmacovigilance agreements. Maintain a local register of all incoming PV related information and all correspondence in relation to Pharmacovigilance activities with agencies and customers based on signed agreements; 9. Perform other duties as assigned.
- **Qualifications and Experience**:_
1. Minimum Life Science Degree
2. Knowledge and familiarity with clinical trials
3. Excellent communication skills
**Job Types**: Full-time, Permanent, Fresher
Pay: ₹28,842.24 - ₹50,538.49 per month
**Benefits**:
- Health insurance
- Provident Fund
Schedule:
- Day shift
- Monday to Friday
Supplemental Pay:
- Performance bonus
- Yearly bonus
**Experience**:
- total work: 1 year (preferred)
Work Location: In person
-
Pe-pharmacovigilance
6 days ago
Mumbai, Maharashtra, India Cognizant Full time**Job Summary** Join our dynamic team as a Pharmacovigilance Specialist where you will leverage Generative AI to enhance drug safety processes. This hybrid role offers the opportunity to work on cutting-edge projects in Research and Development and PV Case Processing ensuring the well-being of patients worldwide. With a focus on innovation you will...
-
Pe-pharmacovigilance
1 day ago
Pune, Maharashtra, India Cognizant Full time**Job Summary** Join our dynamic team as a Pharmacovigilance Specialist where you will leverage your expertise in Generative AI to enhance drug safety processes. With a focus on innovation and precision you will contribute to the development of safer pharmaceutical products. This hybrid role offers a unique opportunity to work in a collaborative environment...
-
Pharmacovigilance Associate
2 weeks ago
Pune, Maharashtra, India Cliniweb Services Full timeA pharmacovigilance associate ensures compliance with applicable regulations or standard operating procedures; specialises in drug safety management, clinical trials and medical supervision. - Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and...
-
Pharmacovigilance Associate
1 day ago
Pune, Maharashtra, India Statistical Pharma Full time1. General Responsibilities and Regulatory Compliance: - Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File). - Monitor national pharmacovigilance legislation. - Ensure appropriate interpretation...
-
Executive - Pharmacovigilance
3 days ago
Mumbai, Maharashtra, India Piramal Pharma Solutions Full timeBusiness: Critical Care Department: Pharmacovigilance Location: Kurla, Mumbai Travel: No **Reporting Structure** Reports to Manager **Key Roles/Responsibilities** - End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to...
-
Pharmacovigilance Associate
2 weeks ago
Karve Road, Pune, Maharashtra, India Statistical Pharma Full time1. General Responsibilities and Regulatory Compliance: - Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File). - Monitor national pharmacovigilance legislation. - Ensure appropriate interpretation...
-
Pharmacovigilance Manager
2 days ago
Narkhed, Maharashtra, India Cipla Pharmaceutical Limited., Kurkumbh, Pune Full time ₹ 5,00,000 - ₹ 15,00,000 per yearCompany DescriptionCipla Pharmaceutical Limited., Kurkumbh, Pune, is a biotechnology company based in Pune, Maharashtra, India. The company is located in Flat No 10, Sanskruti Apt, Near Gokul Hotel, Dound. Cipla is dedicated to developing and manufacturing high-quality pharmaceuticals that contribute to a better quality of life for patients. Cipla is...
-
Pharmacovigilance Associate(Fresher)
1 week ago
Hadapsar, Pune, Maharashtra, India Clariwell Global Services Full timeA pharmacovigilance associate ensures compliance with applicable regulations or standard operating procedures; specialises in drug safety management, clinical trials and medical supervision. - Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and...
-
Executive Pharmacovigilance
1 day ago
Mumbai, Maharashtra, India Piramal Enterprises Full timeBusiness: Piramal Critical Care Department: Pharmacovigilance Location: Kurla, Mumbai Travel: Low **Job Overview**: The Executive Pharmacovigilance will be responsible end-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to applicable...
-
Sme-pharmacovigilance
2 weeks ago
Mumbai, Maharashtra, India Cognizant Full time**Job Summary** **Responsibilities** - Triage & intake of ICSRs in ARGUS databases within agreed timelines - Download and monitor valid ICSRs from Eudra Vigilance (EV) - or any other sources - Process literature, spontaneous, clinical trial, and solicited cases - Search for valid ICSRs in Literature search tools - Generate reports and submit to health...