42 Clinical Pharmacology Jobs - Page 2

Strategic/Policy: Medical Advisor With support from the mentor or Line manager, provide tactical and strategic inputs, and business/technical expertise , to Product Management towards ethical promotion of assigned products, in the operational areas listed Operational Commercialization/Promotion of Allocated Portfolio (New/Key Detail/In-line Products) Under supervision from the Line manager or the mentor, provide strategic inputs and support towards creation of marketing/brand plans/medical development plans, and towards design and execution of medical-marketing programs/clinical programs, including initiatives to enhance access to medicines Under supervision from the Line manager or mentor, initiate and/or review and/or approve promotional, training, and Continuing Medical Education (CME) material in compliance with relevant SOPs/regulations/industry codes/working practices In consultation with the Line manager or mentor, participate /facilitate/conduct customized promotional/educational interactions with Health Care Professionals (HCPs). These interactions include, but are not limited to, customer launch meetings, advisory boards, CME programs, scientific symposia, institutional presentations, etc. Clinical Research In consultation with concerned stakeholder/vendor/interface, develop/write and/or review and/or approve protocol synopsis/final protocols/supporting documents per need (e. g. , investigators brochure (IB), informed consent form (ICF), patient information sheets, etc ) for , Phase IV, PMS, Observational studies / surveys, Pharmacoeconomic / Outcomes Research studies, and other clinical projects / programs. In consultation with concerned stakeholder/vendor/interface, review and approve additional supporting documents/databases including ICF/CRF/SAP, etc Assist in planning, organizing and preparing Investigational New Drug Applications (NDAs) Review/interpret data generated; write final reports for locally sponsored studies as required Develop and execute Publication Plan; review/approve/write manuscripts for publication of locally sponsored studies Develop and execute Information Dissemination Plan/Program Medical Information Provide useful, timely , accurate , and balanced medical information to internal (sales staff) and external (HCPs) customers, in adherence to relevant SOPs/policies Sales Force Training Provide medical training to new sales staff on basic sciences/ TAs/assigned products. Provide refresher training to sales staff through ongoing training initiatives Provide pre-launch and launch training to sales staff for new products New Product Planning/Development For global products, assist NPP team with preparing business case, and pre-commercialization programs/initiatives/activities to prepare internal and external stakeholders for commercialization. These include assistance with market research, stakeholder mapping, and early access programs Support New Product Planning, Marketing, and Business Development colleagues with medical evaluation and recommendations on commercial opportunities with new products (e. g. , licensing, acquiring , co-promotion, etc. ) Support organization efforts at developing local formulations/line extensions through literature search/recommendations. Function as custodian for coordinating internal and regional approvals through the RFD (Request For Development) process Regulatory Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/ indication . Provide medical and product expertise towards defense of marketed products (regulators, NGOs, press, etc. ) Write, revise, and review labeling documents for pipeline/local products per relevant SOPs Provide medical support towards processing of spontaneous/ solicited AE reports, per relevant SOPs and/or working practices Values and Behaviors: Consistently adhere to/ demonstrate all Pfizer Values/Leader Behaviors, with special focus on excellence, equity, courage and joy. Work in harmony with internal and external stakeholders. Qualification & Experience Basic medical degree (MBBS/BDS/MD/MS/MDS) or doctorate degree ( Ph. D. ) from recognized institution or university with at least 2 years of experience in pharmaceutical industry Graduates in Medicine with at least 3 years of clinical practice or clinical research or other relevant experience Special Skills & Knowledge Basic knowledge of pharmaceutical industry, drug discovery, research & development, commercialization, promotion, and applicable policies, procedures, regulations, and guidelines Knowledge of pharmaceutical medicine including clinical pharmacology, medical and paramedical sciences, medicine and medical statistics and relevant Therapeutic Area/Products Expertise in clinical trial design and methodology , and understanding of interfaces, and conduct Communication skills, both written and verbal (including medical writing and presentation skills) Analytical skills and reasoning, and sound medical judgment/decision making Interpersonal skills, internal & external networking and the ability to impact and influence Work Location Assignment: On Premise Medical #LI-PFE

Medical Writer / Technical Content Writer - Internship This internship is ideal for someone passionate about simplifying medical or technical information into clear, structured documents and engaging content. Good Knowledge of Medical terminology. Required Candidate profile Preparation of protocol for Clinical trials Preparation writing CSR (Clinical Study Report) BDS and MBBS With medical writing for clinical trials Knowledge are Applicable

Alvotech is looking to hire a Senior Principal Scientist to lead and innovate within our clinical pharmacology team . This role offers the opportunity to make a significant impact on our clinical programs and contribute to the development of groundbreaking therapies. We seek a highly experienced scientist with a deep understanding of clinical pharmacology, PKPD analysis, and population modelling. Your expertise will be crucial in designing and planning clinical trials, developing regulatory documents, and ensuring compliance with global standards. At Alvotech, you will play a key role in our mission to improve global access to affordable medicines. You will be part of a dynamic team dedicated to scientific excellence and innovation, enjoying a collaborative work environment, opportunities for professional growth, and the chance to contribute to transformative therapies. Please note that international travel may be required to support departmental activities. Scope Responsibilities: Lead clinical pharmacology activities for assigned clinical programs/trials. Develop and revise relevant sections of regulatory documents and deliverables. Develop the clinical pharmacology strategy, briefing book, study design, and protocol development. Collaborate with biostatisticians on Statistical Analysis Plans (SAPs) and review mock-up displays for tables, listings, and figures. Provide statistical consultation to clinical teams and support decision-making processes. Ensure GCP compliance and high-quality standards for Alvotechs sponsored clinical trials. Support internal and external resources in assay development and validation. Work independently and as part of a multifunctional team to achieve project deliverables. Job Requirements: Masters Degree in a related discipline (PhD in Clinical Pharmacology or related discipline with relevant experience is desirable). Minimum 10 years of experience in clinical trials or clinical pharmacology. Expertise in PKPD analysis, population modelling, and simulation. Experience with large molecules and biosimilars is desired. Excellent written and verbal communication skills. Proficiency in technical software such as Phoenix, WinNonlin, SAS, R, Monolix, and NONMEM. Strong organizational and management skills. Deep knowledge of ICH-GCP and regulatory guidelines. Proven ability to collaborate effectively within cross-functional teams. Strong interpersonal skills, including the ability to build team spirit and communicate openly. What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change peoples lives. The chance to be part of a global and fast-growing company. An international work culture that encourages diversity, collaboration, and inclusion. Positive, flexible, and innovative work environment. A clear and developed organizational structure. Training and global opportunities to advance. A good work-life balance. Home internet and home office equipment. Why Alvotech At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment. True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let s create a healthier world together, through affordable biologic medicines.

Jubilant Biosys is hiring for Senior Research Associate - In Vivo Biology Experience : 5-8 Years Qualification : M. Pharmacy (Pharmacology) Responsibilties : Drug discovery in pre-clinical pharmacology, In-vivo pharmacology, Animal model development and Efficacy study and Pharmacological screening of Pharmaceutical drug molecules in the respective therapeutic areas such as CNS/ Metabolic disorder/ Autoimmune/Inflammatory diseases/ Pain/Oncology in Drug Discovery field. Evaluation of NCEs in target engagement and efficacy models. Responsible for writing of Protocols, uploading of the data, Lab note book record keeping. SOP writing Exploring scientific journals in order to find new ways/techniques to develop the animal models in a robust and reproducible manner. Follow the guidelines followed in the lab towards different safety aspects and help the lab head in designing the new guidelines. Follow ethical guidelines towards assay validation, data analysis and maintenance.

Purpose: Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly . To work with cross-functional, multidisciplinary teams to prepare scientific publications (clinical and/or health-outcomes) including and not limited to, abstracts, posters, manuscripts and presentations. Primary Responsibilities : This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with the hiring team. 1.Content Strategy : Document Preparation, Development and Finalization/Document Management Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects. Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review coordinate and complete the publication of scientific data in peer-reviewed journals and forums Conduct effective document initiation via a kick-off meeting to ensure authoring team alignment and understanding. Build scientific-based rational that support the purpose of more complex and/or strategic documents. Ensure data are presented in a clear, complete, accurate, and concise manner. Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data. Coordinate expert/scientific reviews, collate reviewer s comments, adjust content of document as required based on internal/external input, and prepare final version. Ensure and coordinate quality checks for accuracy, Exhibit flexibility in moving across development and preparation of multiple document types. Influence or negotiate change of timelines and content with other team members. Advocate internally and externally for appropriate authorship criteria on all applicable work products. Work with internal and external speakers to develop and prepare presentations. As needed, build and manage relationships with vendors/alliance partners. 2.Project and Stakeholder management Lead the writing process and apply effective project management skills to ensure timely completion of high-quality scientific publication deliverables. Build/Communicate credible writing project timelines. Anticipate and mitigate risks to delivery Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion. Effectively communicate project status to stakeholders. 3. Knowledge and Skills Development Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s). Maintain and enhance scientific communication skills to align with audience needs and technology/digital evolution. Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment. Maintain and enhance knowledge of publication guidelines. Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in publication planning, integrated planning process, and/or current awareness literature updates and reviews. 4.Knowledge Sharing Provide coaching to others by sharing technical information, giving guidance, answering questions. Recognized for technical expertise in specific document development. Network with others (including other functions and regions) to identify and share best practices. Contribute to process improvements, suggesting opportunities where appropriate. Provide database and other tool (e.g., document management systems) expertise. Minimum Qualification Requirements: Master s degree in a scientific field Experience writing scientific publications. Strong communication and interpersonal skills. Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process) Other Information/Additional Preferences: Advanced degree (PhD, MD, PharmD, MA, MBBS) in science, health related field or other appropriate disciplines (economics, epidemiology, health administration, health services, Pharmacoeconomics, statistics other relevant sciences) Desired: H ealth, communications, health outcomes, health economics, public health related expertise Demonstrated mastery of verbal and written English skills in the medical, scientific, health outcomes, or technical writing fields. Previous training and experience in disseminating results in clinical, health economics, health outcomes, health literacy, disease management, and/or population health. Relevant experience in clinical development, clinical trial process, health-outcomes research, or regulatory activities. Clinical pharmacology, therapeutic area, health outcomes, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise). Demonstrated project management and time management skills. Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates). Extensive experience in writing, reviewing, and publishing scientific materials and the ability to appraise scientific literature and raw data critically. Ability to communicate clearly and succinctly with all audiences and forums through exemplary oral and written communication skills. . .

Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines Processing literature, spontaneous clinical trial and solicited cases Responsible for coding events, indications and patient history based on MEDDRA Required Candidate profile EDUCATION: M.Pharm/Pharm D/Life sciences / Microbiology / Biotech /Biochem /Nursing / BDS EXPERIENCE: Strong Knowledge in pharmacovigilance With Certification or its equivalent.

Role & responsibilities: Ensures that qualified by education, training, and experience to assume responsibility for the proper conduct of the clinical studies. Maintaining current, up-to-date curriculum vitae . Assuming responsibility for the conduct of the clinical investigation. Signing the protocol Documenting the financial aspects of the trial. Disclosing conflicts of interest as described in the regulations. Ensuring adequate number of qualified staff and adequate facilities for conductance of the study properly and safely. Ensures that all persons assisting with the study are adequately informed about the protocol, the investigational product(s), and their study-related duties and functions. Ensuring that medical care is provided to a subject for any adverse event(s) that is reported. Informing a subject when medical care is needed to treat an inter-current illness. Provide information regarding adverse events and serious adverse events to the IRB/IEC. Possessing a thorough understanding of the requirements of each protocol . Ensuring recruitment goals are reasonable and attainable. Assessing overall protocol feasibility. Following the trials randomization procedures. Ensuring that the informed consent form contains the entire Essential and additional elements required. Conduct of the clinical studies specified by the applicable regulatory requirement(s), the IRB/IEC requirements and/or the regulatory authorities. Conduct the study as per the principles of ethics and is compliance with Good Clinical Practices (GCP). Attending education workshops. Reviewing professional publications. Participating in professional societies Maintaining a list of qualified persons and their corresponding trial-related delegated duties. Preferred candidate profile can send to email: hr@qpsbioserve.com or raghavendra.kundhula@qpsbioserve.com Perks and benefits: Nil

RoleClinical & Therapy Development Manager Type Full Time Job description - Successfully complete our internal training plan to include hemodynamics, ECG, angiography, echo CT imaging modalities and complete the case support and proctor delegate authorizations. - Provide active commercial case support, demonstrating excellence in procedural success rates patient outcomes. - Scrub in sterile and provide TAVI valve loading in procedures training instruction to trial and commercial customers - Provide our customers CT valve sizing analysis utilizing the Pie Medical 3Mensio CT program - Lead customer didactic education sessions for account activation before first implants - Lead pre case planning debriefing of heart team pre post procedure and provide ongoing education as requested for proper in - service levels - Provide documentation as required for quality assurance initiatives - Co-develop commercial business plan for assigned region - Co-support internal/external quarterly business reviews - Data entry into Salesforce, Mentor software for customer case support management - Learn commercial data analytics, resources tools for effective customer experience - Support customer engagement strategy with Marketing team (TM)) - Demonstrate competency with marketing messaging, clinical evidence and medical education portfolio offering - Demonstrate knowledge in the TAVI market, industry competitive insights - Participate in team meetings, conventions, and national sales meetings as requested - Drive innovative marketing and referral activities in collaboration with the markeitng team - Collaborate with the Sales and marketing team to conduct targeted market development in India Sub-continent. - Lead organization and delivery of key symposia by supporting discussions with customers to define agenda topics, select appropriate speakers / chairs, create required materials for events. - Develop Key Opinion Leaders within this segment to create market for the new therapies which will be launched and create advocates for your product who will speak on various forums - Identify high potential international / national referral community meetings to target for market development and collaborates with sales management team to put forward case for investment (program contributions / symposiums / workshops) This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Phoenician Medical Center India Pvt. Ltd. is a US Healthcare Company based in Gurgaon, Haryana . For more information, please visit our website https://pmchealth.care/ Job Title: - Clinical Pharmacist Openings: - 4 Job Location: sector-18, Gurgaon (Work from office - Night Shift) Job Description:- To handle queries of US patients on call and provide them the required medical assistance and care regarding prescribed medicine or any health issue. Desired Candidate: Must have 2 to 4+ years of work experience in any Medical Facility Must have B. Pharma degree or Pharmacist diploma Excellent communication skills . Excellent command over English language Strong knowledge of human anatomy and physiology In-depth understanding of acute and chronic diseases and their respective medications. Good typing and computer skills Ability to work independently as well as in a team environment Strong analytical and problem-solving skills Should be willing to work from our Gurgaon office. We do not provide work from home Benefits Night Shift - 8:30 pm to 5:30 am Meal facility Cab Service 5 days working per week Only relevant candidates with fluency in English language need to apply by sharing the CV at careers.india@pmchealth.care or contact Ms. Lalita Istwal on 9910378543 for further queries.

Job Title: Senior Scientist - In Vitro Secondary Pharmacology Career Level: D Introduction to role: Are you ready to make a significant impact in the world of drug discovery and developmentJoin AstraZenecas Clinical Pharmacology Safety Sciences (CPSS) department, where innovation meets collaboration. Our Safety Innovation team is at the forefront of advancing a diverse pipeline across therapeutic areas, delivering safety science from early discovery through clinical development. We are seeking a talented in vitro pharmacologist to join our Secondary Pharmacology team, contributing to the clinical advancement of new medicines. Accountabilities: In this pivotal role, youll leverage your expertise in pharmacology, toxicology, and biology to collaborate with drug safety specialists and project safety pharmacologists. Your insights will shape drug design during the early phases of discovery, ensuring the selection of safer molecules and developing strategies to mitigate safety risks. Youll generate in vitro pharmacological profiling data at contract research organizations (CROs), identify off-target risks, and interpret pharmacological interactions. Your work will translate in vitro activity into pre-clinical and clinical adverse events, providing crucial guidance for project decisions. Essential Skills/Experience: PhD or Masters or equivalent experience in a relevant scientific field with 4+ years of industrial experience. A strong background in pharmacology (e.g., pharmacology, biology, biochemistry, toxicology, physiology) with a proven track record in driving innovative science, preferably in the pharmaceutical or biotechnology industry. Technical experience in in vitro pharmacological or biochemical assay development and screening (e.g., kinase profiling technologies, radioligand binding, enzyme activity, and functional cell-based systems) applied to various biological target classes. Excellent problem-solving and organisational skills, delivery focus, and outstanding communication skills. A true collaborator with highly effective networking skills and experience collaborating across scientific disciplines, cultures, and expertise. Desirable Skills/Experience: Experience with off-target profiling data and strategies in the pharmaceutical industry. Practical understanding of kinase profiling technologies. Experience working with CRO s, commissioning requests and driving delivery processes. Experience with being entrepreneurial taking the initiative in projects. Demonstrated leadership in scientific projects or teams. Experience in regulatory interactions or safety assessments. Knowledge of emerging trends in drug safety and pharmacovigilance. At AstraZeneca, we are driven by curiosity and courage, exploring what science can achieve. Our commitment to making a difference is unwavering as we fuse data and technology with scientific innovation to tackle some of the worlds most complex diseases. We celebrate successes and learn from failures, creating an inclusive environment where diverse knowledge is leveraged for swift impact on disease. With opportunities for lifelong learning and career growth, AstraZeneca is where you can push boundaries and deliver life-changing medicines. Ready to make a differenceApply now and be part of a team that transforms patient lives through groundbreaking science! Date Posted 23-May-2025 Closing Date 03-Jun-2025

Fortis Hospital Mohali is hiring for Head Clinical Pharmacology interested candidates can share profile at baljinder.singh@fortishealthcare.com

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. EMS (Executive Medical Summary) Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects. Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration. Conduct effective document initiation meeting to ensure authoring team alignment and understanding. Build scientific-based rationale that support the purpose of more complex and/or strategic documents. Ensure data are presented in a clear, complete, accurate, and concise manner. Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data. Coordinate expert/scientific reviews, collate reviewer s comments, adjust content of document as required based on internal/external input, and prepare final version. Ensure and coordinate quality checks for accuracy . Exhibit flexibility in moving across development and preparation of multiple document types. Influence or negotiate change of timelines and content with other team members. Work with internal and external experts to develop and prepare presentations. As needed, m ay build and manage relationships with vendors/alliance partners . Project and Stakeholder management Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents. Build/communicate credible writing project timelines . Anticipate and mitigate risks to delivery Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion. Effectively communicate project status to stakeholders Knowledge and Skills Development Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s). Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment. Maintain and enhance knowledge of regulatory guidelines and publication guidelines. Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews. Maintain and enhance the scientific communications skills to align with the audience needs and with the changes in technology and platforms. Knowledge Sharing Provide coaching to others by sharing technical information, giving guidance, answering questions. Recognized for technical expertise in specific document development. Network with others (including other functions and regions) to identify and share best practices. Contribute to process improvements, suggesting opportunities where appropriate. Provide database and other tool (e.g., document management systems) expertise. Minimum Qualification Requirements: Bachelor s degree in a scientific, health, communications, technology health related field . Demonstrated experience in technical/ regulatory scientific writing . Strong communication and interpersonal skills. Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process ) Other Information/Additional Preferences: Graduate degree with formal research component or in life sciences. Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields . Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise). Experience writing regulatory, clinical trial documents and/or publications Experience writing deliverables for Medical Affairs communications (slide decks, patient or HCP materials, etc ) Experience in clinical development, clinical trial process or regulatory activities . Demonstrated project management and time management skills. Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).

We are currently hiring for DSA I role with a minimum of 3 to 5 years Of experience in Pharmacovigilance Perform triage & intake of ICSR received daily in ARGUS databases. Ensure data entry of ICSR in ARGUS Knowledge In Aggregate Reporting is Must Required Candidate profile Require 3 to 5 years of pharmacovigilance case processing experience. Responsible for coding events using MEDDRA Any Life Sciences(B pharm/M Pharm/ Pharm D, Life Sciences, Nursing, BDS, BPT)

We are currently hiring for DSA I role with a minimum of 1 year experience in Pharmacovigilance Perform triage & intake of ICSR received daily in ARGUS databases. Ensure data entry of ICSR in ARGUS Required Candidate profile A minimum of 1 year pharmacovigilance case processing experience. Responsible for coding events using MEDDRA Any Life Sciences(B pharm/M Pharm/ Pharm D, Life Sciences, Nursing, BDS, BPT) are Eligible

Basic understanding of Clinical pharmacology, pharmacokinetics and toxicological aspects Review of literature and preparation of Biopharmaceutics review, Dissolution studies , Biowaiver/Bio strategy Basic understanding of bioequivalence studies for various regulatory agencies Review of study specific documents for BE studies (like study protocol, ICF,CRF, CSR, TMF) Monitoring & audit of clinical phases of Biostudies and Quality management system Co-ordination with CROs for execution of Pilot and Pivotal bioequivalence studies. Co-ordination with internal departments for BE NOC/TL documents and project contracts/invoices. Management, receipt, logistics and shipment of study IMPs to CRO’s Submission of finalized BE reports to regulatory department for submission and handling of regulatory queries related to module 5. Basic understanding of GCP Guideline and Clinical trials, NDCT Rule etc