Career opportunity for Safety Associate II at inVentiv Health "A"

Job Description:


- Process adverse event reports received from sites/reporters.
- Perform QC review of completed individual and periodic safety reports.
- Complete data entry including writing of adverse event narrative and provide preliminary assessment of event seriousness and expectedness/listedness as per applicable Reference Safety Information.
- Generate adverse event queries, liaise with the medical reviewers/client to agree upon the queries, and send request for additional information to the sites/reporter.
- Engage with the Site Monitors to ensure follow up information is obtained from site effectively.
- Foster constructive and professional working relationships with all project team members, internal and external.
- File documents according to project specific requirements (electronically or in hard copy as applicable).
- Ensure case files are compliant with SOPs.

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Novartis jobs for Regulatory CMC "A"

Job Description :
1. Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
2. Prepare CMC responses to health authority questions during development, registration and product lifecycle.
3. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
4. Identify content, quality and/or timeliness issues with source documents, or any other potential au-thoring issues that may impact submission quality or timelines, as early as possible.
5. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global re-gions as well as for new technical trends.
6. Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
7. Establish and maintain sound working relationships with partners and customers.
8. Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).



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Drug Safety Physician required "A"

Job Description 


Report preparation [e.g. Periodic Safety Update Reports (PSURs), Addendum PSURs, Bridging Reports, PSUR Line Listings, US PADERs] from aggregate data for products, in accordance with client conventions and requirements;
Quality checks of aggregate reports; Signal detection-related analyses and reports including cumulative analyses, issue event analyses, Drug Safety Reports , review of published literature and case listings; Vigilance over important/designated medical events;
Interaction with client personnel to discuss potential signals and issues detected with products; Support preparation and maintenance of Risk Management Plans;
Follow-up and interaction with clients to obtain incomplete/missing information, with a view to resolving and clarifying issues;
Performing medical review of individual case safety reports (ICSRs); performing medical review of narratives for Clinical Study Reports (CSRs);
Providing medical advice to drug safety scientists to assist them with processing of ICSRs and CSR narratives;
Maintaining an excellent knowledge of the adverse event safety profile of assigned drugs, labelling documents, and client guidelines and Standard Operating Procedures (SOPs);
Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for report submissions;
Maintaining records in compliance with guidelines and SOPs

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Synowledge hiring for Drug Safety Associate "A"

Synowledge, our mission is to help our clients improve patients’ quality of life though cutting-edge technology solutions and innovative consulting services. With nearly 10 years’ experience, Synowledge has become a strategic partner with many Top 20 Pharma and Fortune 500 companies. Our technology solutions and innovative consulting services help life sciences companies reduce cost, accelerate growth and minimize time to market during the drug development lifecycle.

Post : Drug Safety Associate - Translation

Job Description : 
The DSA will be responsible for processing and translating individual case safety reports from English to Japanese and vice versa, therefore fluency in both English and Japanese (written and spoken) is essential (University degree in Japanese or certified in JLPT N3 or higher)
Duties within this role will include

• Responsible for Case intake, duplicate check , and registration    
• Responsible for Data entry of single cases into Safety Database Application    
• Review and evaluate AE case information to determine required action based on and following internal policies and procedures    
• Responsible for writing medically relevant Safety narrative of cases    
• Perform any other drug safety related activities as assigned    
• Perform Literature Review activities when trained and assigned

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Responsibility of Drug Safety Associate "A"

 Receive, follow-up and report adverse events
- Review and process adverse events reported by Investigators
- Prepare Safety report as per Schedule-Y format to be reported to regulatory authorities and also other Investigators, who are part of the study
- Research and provide medical and scientific information to health care professionals and to various functional areas within the company
- Conduct and analyze, medical and scientific literature searches using critical judgment and professional / scientific expertise to support projects or queries
- Review clinical trial protocols, bioequivalence study protocols and provide inputs, support the clinical trial team
- Generates concise, accurate and well-written case narratives
- Responsible for effective and efficient development of the safety management plan, including development of specific processes to assure consistency within the project
- Effectively maintains the safety database and corresponding entry guidelines, including accurate entry of data and assurance of quality of data through quality control process
- Performs consistent coding of diseases, adverse events, and medication according to the project-specific coding conventions
- Supports the generation of Annual Safety Updates, Periodic Safety Reports, and other cumulative safety reports including data retrieval, analyses and quality control
- Reconciles SAEs in accordance with project specific guidelines
- Represents team at client meetings; contributes presentation of safety process at investigator meetings

source:http://www.clinicalresearchsociety.org/forum/pharmacovigilance/what-is-the-resposibility-of-drug-safety-associate/ 

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Mega Openings with Accenture for Drug Safety Associate "A"

Job Description

Responsibilities/Authorities : 

1.Prioritise Data Entry activities for Cases by reference to the Date Receipt in accordance with SOPs and Guidelines;
2.Data entry of safety information, including relevant medical history and laboratory data and therapy dates into the applicable Global Safety Database in accordance with Guidelines and SOPs;
3.Validate data consistency and make any corrections as needed;
Submit to Case Safety Reports for scientific and medical evaluation;
4.Review responses to queries when received and update the Global Safety Database as required;
5.Document any amendments to the Data Entry Conventions and agree these with the client Functional Lead, prior to their implementation;
6.Participate in clinical study reconciliation activities, as requested by client; and
7.Issue reconciliation listings as requested by client to the relevant Connected Entity and to client.

Requirements 

Fresher's also can apply with B.pharma/M.pharma/BDS/Pharma D from 2014,2015,2016 passed out.
Healthcare degree preferred;
For Experienced: 

A minimum of 2 years Pharmaceutical or Clinical experience is preferred;
1.Experience with MS Office products;
Knowledge of coding applications, databases, processes and tools is preferred;
2.Experience in researching information utilizing available resources including publications and the World Wide Web;
3.Effective communication, organisation and time management skills;
4.Good interpersonal skills and the ability to operate effectively in an international environment;
5.English language (written) proficiency must.
6.Thorough knowledge of medical terminology;
7.Computer proficiency and ability to work in specific databases;
8.Excellent written and verbal communication skills is a must
NOTE :
Candidates from Bangalore preferred.
candidates should be flexible to work in shifts.

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Novartis hiring Pharmacovigilance Scientist "A"

Job Description :

• Subject Matter Expert
• Contribute to DS&E projects
• Assess seriousness, causality and labeling of serious adverse events and quality check ICSRs to ensure accurate and consistent Argus data entry from source documents.
• Author/co-author, along with Global Medical Safety Physicians, regulatory periodic safety re- ports (Periodic Safety Update Reports, US Periodic Reports) for Novartis mature portfolio: collecting, organizing, analyzing and presenting the data by means of DS&E templates and procedures.
• Lead/co-lead cross functional expert teams to fulfill Periodic Safety Report accountabilities (DRA, Clinical, Marketing).
• Review global marketing programs and establish process for AEs collection with global marketing teams.
• Review Risk Management Plans in coordination with Global Medical Safety groups and assess the operational feasibility and implications of Pharmacovigilance commitments.
• Collaborate with Electronic Data Management team to reconcile Serious Adverse Events be- tween the Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database.
• Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.
• Member of Safety Profiling Teams to ensure that case reports are accurately evaluated and database, authoring or contributing to Product Specific Guidelines for assigned products.
• Contribute to the preparation of Standard Operating Procedures and Argus processing conventions (MAP).

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