Thepharmadaily Jobs in India

Manage the operational aspects of CROs supporting Novartis BR scientific functions and projects under the supervision of ORE team members. · Drive efficient, cost-effective, high-quality infrastructure and logistics for outsourcing scientific activities, including invoice reconci ...

Acting as the owner of the safety sections of the labeling for the evolving Company Core Data Sheet (CCDS) for development products. · Maintaining labeling for marketed products and participating as a labeling change request (LCR) reviewer. · Preparing relevant sections of Develo ...

Responsibilities · Perform troubleshooting, optimization, and performance tuning for recurring data extracts and ad-hoc reporting. · Validate results of deliverables against project scope, using knowledge of the healthcare industry, market, and standard operating procedures. · De ...

Key Qualifications · Degree in a life science, nursing qualification, or relevant experience. · Minimum of 3 years experience leading clinical operations of clinical trials in a COL, CTM, or CPM role within a CRO. · Prior monitoring experience (preferred) or clinical trial coordi ...

Complaint Management: · Review and process product complaints, ensuring adherence to both internal procedures and external regulations. · Regulatory Reporting: · Determine regulatory reporting requirements and manage Health Authority Requests in compliance with EU MDR 2017/745 an ...

Position Summary · The role supports the Health Economics and Value Assessment (HEVA) team in the assigned therapy area portfolio to plan and generate robust health economics and value-based evidence from both a global and US perspective. The position works within the Market Acce ...

Understanding to work on International Reference pricing. Provide accurate results to Stakeholders which may include pricing information. Understand the complexity of Pricing system across different regions. Working on Price business cases, price certificates. · Support ad-hoc ta ...

Perform medical review of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), including analysis of narrative content, coding, expectedness, seriousness, causality, and company summary to meet service level agreements and regulatory timelines. · E ...

Perform accurate coding of medical terms and medications utilizing industry-wide standards as well as company standards; · Coordinate the assignment of appropriate dictionaries for meeting study requirements; and · Develop and maintain coding guidelines · Qualifications · Bachelo ...

Job Description · Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Codi ...

Job Description · Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Codi ...

Key Responsibilities: · Perform as the ICSRs Project Lead for assigned pharmacovigilance projects. · Oversee the receipt and processing of all adverse event reports, whether from spontaneous sources or clinical trials. · Maintain knowledge of client-specific database conventions. ...

Responsibilities · Produce high-quality and detailed medical notes based on patient-doctor conversations. · Ensure the delivery of 99% accurate medical notes to assist US physicians effectively. · Qualifications · Excellent communication skills in English. · Willingness to work r ...

This role offers an exciting opportunity for individuals with strong technical writing skills to contribute to the creation of comprehensive technical documentation. · Responsibilities: · Needs Assessment : Determine customer needs and develop technical documents to meet those re ...

Project Leadership: Serve as the ICSRs Project Lead for post-marketing pharmacovigilance projects, adhering to client contracts and applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs). · Adverse Event Management: Oversee the receipt and processing of all a ...

As Sr. PV professional, ICSR quality, part of ICSR Quality KPIs, reports & metrics Team within the ICSR Quality, KPIs & Metrics sub-function within Patient Safety Operations (PSO), the role in the Global Patient Safety & Pharmacovigilance department within Teva Global R&D (Resear ...

Perform medical review of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), including analysis of narrative content, coding, expectedness, seriousness, causality, and company summary to meet service level agreements and regulatory timelines. · E ...

Experience : Around 2 to 4 years of relevant experience in handling pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. · Regulatory Framework : Good understanding of regulatory framework, including regional tren ...

Key Responsibilities · Toxicological Risk Assessment: · Evaluate impurities and excipients in pharmaceutical products to assess potential health risks. · Structure-Activity Relationship (SAR) Evaluation: · Analyze chemical structures using Structure-Activity Relationship methods, ...

Essential Functions: · Independently manage assigned sites and perform Subject Level Data Review; perform dual roles if required. · Conduct remote monitoring visits as assigned. · Investigate clinical data at the site level to ensure accuracy and completeness of patient informati ...