Drug Safety Associate-PAREXEL International (India) Pvt. Ltd.- Hyderabad / Secunderabad , India - Telangana - Hyderabad

 

Job Description

 

The DrugSafetyAssociate will provide technical and process-related support to drugsafety management (clinical trial and post-marketed) and medical monitoring activities, regulatory information collection and organization, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
For members of the Global Pharmacovigilance Information Office (GPIO):
o Support collection and organization of global PV requirements
o Data entry and maintenance of country specific requirements in PAREXEL PV repository
o Receipt and triage of requests for updates to country requirements
o Communicate country-specific regulatory updates to project teams as required
o Maintain updated network list of Named Safety Contacts/LQPPV
o Work directly with relevant stakeholders on standalone GPIO projects 

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Regulatory Affairs Intern (london) - Only for 6 Months

Job Description

 

• Preparation, compilation & submission of Dossiers in CTD, ACTD as well as country specific format For African, Southeast Asian, and Latin America countries like. Kenya, Nigeria, Ghana, Philippines, Myanmar, Vietnam, Sri Lanka, Cambodia, Guyana, Guatemala, EL Salvador, Tanzania, Syria, Yemen etc. 
• Responding to technical queries related to product registration.
• Evaluation and preparation of post approval supplements to manage the regulatory product as applicable.
• Coordinate and consult with other department for accurate and timely assembly of regulatory document for submissions.
• Knowledge of New Product Development. 
• Reviewing technical documents and checking of Artworks as per the countries guidelines.
• Co-ordination with International Customers 
• Technical data support to dossier preparation for UK.
• Replying to product based queries on the basis of clinical studies asked by medical fraternity. 
• Keeping up-to-date with changes in regulatory legislation and guidelines
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Executive/ Assistant- Medical Writer InfocusRx Marketing & Communication Pvt. Ltd. - Hyderabad / Secunderabad

Job Description

 

Looking for a promising career and rewards?
Welcome to InfocusRx - Experts in medical content, design, and technology services. We are seeking candidates having professional qualifications like : Masters in Science, M-Pharma, MBBS, BDS, , BAMS, Pharma-D and relevant degree in Health Sciences to be a part of our in-house medical communication team.
Today, with its team synergy and expertise in research, content and design, the company focuses on providing content writing, business research, advisory, marketing, interactive and website design services for medical/healthcare verticals. Our clients include progressive start-ups, entrepreneurs, venture capitalists, Universities, mid-size and fortune 500 firms.

Job responsibilities
As medicalwriter you would be writing, editing and providing quality content for medical / health science training ware development.
You need to ensure accuracy and completeness of training document and format.
Should be able to perform other responsibilities as assigned.
To develop high-quality, publication-ready scientific documents (Monographs , Newsletters , Journal supplements , Booklets ,Leave-behinds ,Speaker kits ,Poster presentations, Continuous medical education (CME) ,Medical conference coverage)

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Opening for Medical Writing- MBBS / MD at Indegene, Bangalore

Job Description

• Develop content for various deliverables meeting quality requirements as per client satisfaction metrics, with active guidance from the manager
• Responsible to develop content as per the timelines assigned
• Responsible to follow the best practices in the department regarding - processes, communication (internal & external), project management, documentation and technical requirements like - language, grammar, stylization, content search, summarizing, data conflicts and referencing
• Participate in assigned training programs and work on assignments as per requirement
• Participate in client calls as per project requirements
• Compliance to quality, confidentiality and security:
• Adhere and follow quality systems, processes and policies
• Comply to training and specifications

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Job Profile of Pharmacovigilance Officer in Pharmacovigilance Project

• Responsible for processing Adverse Event cases on the Safety database.
• Perform the duplicate case search function in software.
• Review the source document to assure relevant information pertaining to the case is appropriately entered into the database fields.
• Responsible for processing Initial/Follow-up Spontaneous, Solicited, Clinical trial Serious/Non-serious Cases.
• Event Coding by MedDRA (Medical Dictionary for Drug Regulatory Activities).
• Assessment of events with product, also case validity.
• Used CDD (Company Drug Dictionary) and WHO Dictionary for drug coding.
• Completion of remaining case data entry, including narrative writing or Auto-narrative.
• Creation of follow-up letter for required cases.
• E2B Validation of the Case.
• Follow Up activities.
• E2B Linking reports and cross reference reports
• Routing of Spontaneous/Solicited/Clinical trial cases, Serious/Non-serious cases to the appropriate workflow state.
• Responsible for performing daily activities in accordance to applicable Standard Operating Procedures (SOPs), Conventions and Client policies.
• Quality auditing for cases