Qualification & Experience           The candidates should have a GNM or a B.Sc. Nursing qualifications (with valid registration). The role encompasses patient care, assisting with procedures, administering medications, and maintaining accurate clinical records.

Responsibilities Manage Contract Research Organization (CRO) for effective execution of interventional, non interventional and epidemiological studies  Identify potential investigators and sites for clinical studies in collaboration with CROs and India Medical Affairs team  Support in preparation and review of clinical trial documents for Ethics committee (EC) & Drugs Controller General of India (DCGI) and/or other regulatory submission (as applicable)  Vendor management as per Sun Pharma’s applicable policies & procedures  Coordination with investigator and sites for executing clinical study agreements & financial agreements in co-ordination with CRO  Coordinate with internal stakeholders (Medical, Regulatory, Quality Assurance etc.) for timely regulatory submissions  Plan Investigational Product and other related trial material requisition, procurement, and dispatch  Ensure timely reporting of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSAR) to regulatory authorities and reporting of SAEs to all sites and investigator.  Ensure training of CROs on Sun’s Pharmacovigilance (PV) practices.Qualification & ExperienceBachelor's or Master's degree in a field related to Science, Healthcare, Clinical Research or Life Sciences like Biology, Pharmacology, Nursing, or a related discipline, and/or Post-graduate Diploma in Clinical Research. Experience 3–5 years of experience in a CRO/Pharma/Biotech organization in clinical trial operations.  Experience in handling large clinical trials with multiple sites for different therapeutic areas 

Responsibilities  Authorized to sign as a doer and verifier in:  Batch Manufacturing Record, BMR Requisition, BMR Issuance Logbook.  Protocols, Risk Assessment.  Authorized to sign as a checker/verifier in following document,  Finished product logbook etc.  To prepare new BMR, revise BMRs within time.  To assist in preparation of Change Control, Corrective Action Plan & New Equipment’s preparation.  Handling of corrective and preventive action.  To ensure the compliance of various in-process control instructions provided in BMR, MBMR.  Preparation and updation of SOPs, BMRs, Log books, protocols and compliance thereof with training of people on the same.  Handling and monitoring of Environmental monitoring system (EMS) system.  To maintain daily production report, machine utilization on day to day basis.  To learn EMS, review the report on daily basis. (Action, alert limit, breakdown maintenance).  Training to all technician & supervisor for new BMRs and revised BMRs to comply with the GMP.  To prepare process performance qualification/process validation protocols, study protocols.  To prepare failure mode effect analysis, risk assessment for product/process.  To undergo functional training, cGMP training or any other training identified as per schedule.  Any other responsibility assigned by department head after ensuring the relevant training status. Qualification & ExperienceQualification  Bachelor’s degree in Pharmacy,Experience 5+ years

ResponsibilitiesDevelopment of marketing and promotional plans for products to support the end consumers’ need Ensuring marketing strategy implementation through sales force connect Market intelligence through primary research and customer connect Collaboration with internal & external media to ensure the proper execution of strategies Providing training, product knowledge, and direction to the field sales team to ensure that they are well-equipped with scientific and communication skills both. To work with cross-functional teams like medical affairs, the learning and development team, and R & D team (Research & Development) in the process. Developing brand plans/strategies for the product range along with market penetration strategy market research and competitor analysis. SWOT analysis of product line (strengths, weakness, opportunities, and threats) and guiding sales team to tap the opportunities and growth in the product sale. Creating brand inputs for promotion like VA, LBL, Newsletter, flipcharts, or digital campaigns like a website or app launch or webinar series, etc. Conducting meetings, scientific symposia, CMEs, and conferences, and ensuring brand visibility in the target audience segment of the pharmaceutical industry, which are healthcare professionals and hospitals. Motivating sales team members by organizing training camps, award ceremonies, and recognition programs. Product forecasting, new product pipeline strategy, new product pre-launch and launch strategy and post-launch, new initiatives for product growth strategy.Qualification & ExperienceB. Pharm / M. Pharm & MBA Experience 3-4 years

ResponsibilitiesSafety Physican Role : Responsible for the preparation/ review of safety aspect in clinical documents,clinical study concepts, clinical study protocols, Investigator’s Brochures, clinical study reports, clinical modules of CTD, response documents for EC, MoH on the program. Take on role of safety physician for global clinical studies/programs. Responsible for the medical oversight during trials and functions as SME for scientific and medical questions during the trials. Review of safety review plan, SAE reconciliation, safety listings and coding during the trials/programs Primary study contact for sites’ personnel and project team in the event of medical-scientific questions Collaboration with the other members of the Pharmacovigilance team to process Serious Adverse Events for the clinical trials to which is assigned as CRP Review of CROs-Medical assessment of adverse event reports, detecting and assessing risks and proposing risk mitigating activities Case Narratives review, Coding of medical terms Participating in Risk management activities like protocol modifications due to safety or efficacy concerns, restrictions in study population or indications, changes to the informed consent document relating to safety issues, newsletters to investigatorsQualification & ExperienceMD or MBBSMinimum Experience/Training Required : At least 5-7 years of experience in pharmaceutical industry with minimum of 3 years in relevant clinical development. Ability to lead clinical programs and to run teams in multi-cultural environment at different sites. Expert knowledge of clinical trial methodology, oversight/evaluation of safety and regulatory requirements governing clinical trials.

ResponsibilitiesPrimary focus is on providing and leading support of site management activities such as collection of essential regulatory documents. Reviews and analyzes regulatory documents for accuracy and completeness per Good Clinical Practice (GCP) and Good Documentation Practice (GDP) standards. Updates and maintains internal clinical trial information and document management systems. Maintain local regulatory documents on paper or electronically as applicable and ensure upload to data management system (SO). Supports creation of patient and regulatory binders throughout the study lifecycle. Supports regulatory and clinical protocol compliance for all clinical projects at the assigned sites. Drives collaboration with site partners with Site Management and Operations to address Business Unit deliverables such as supporting the follow-up and resolution of findings from monitoring visits and audits, when requested. Communicates and collaborates with all levels of employees, customers, contractors, and vendors. Performs review of site compliance under supervision and escalates issues to site operations management and/or study management. Updates and maintains internal clinical trial information and document management systems. May contribute to global or regional process improvements. Have a good understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education about Abbott devices and therapies. Clinical inventory management with site and local warehouse. Liaison between site, global project management, Device Accountability Specialist, local warehouse, and local customer service. Manage import and export processes per local regulations and applicable Abbott work instructions and SOPs. Initiates translations of study and site level documents as applicable, including the Patient informed consent, and other study documents, as requested. May make additional contributions as assigned.Qualification & ExperienceBachelor’s degree preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering with a minimum of two years of experience, or an equivalent combination of education and experience

ResponsibilitiesEnsure compliance of global ICSR distribution by correct distribution rule set-up in the Safety Database. This includes : Regular monitoring of regulatory information system. Regular review of distribution requirements received from ASRs Perform plausibility checks and impact analysis of changes in regulations and ensure implementation of distribution rules in Safety Database Contact person for ASRs for redistribution of cases, updates of distribution rules, contacts, products, timelines and local requirements in the Safety database Contact person for ICSR reporting requirements for other GPV groups, e.g. Case Processing, QPPV, Compliance, Safety Database OperationsQualification & ExperienceMaster in Science, Ph.D. in Life Sciences, B.E. or B.Tech or equivalent Excellent English communication skills Minimum Experience/Training Required : Minimum working experience of 10 years in Pharmacovigilance, in particular :

Qualification & Experience                 Desired Qualification : BPT / MPT (Bachelor / Master of Physiotherapy)        Preferred experience Minimum : Fresher               

Qualification & Experience           Desired Qualification : MD in Pathology      Preferred experience Minimum : Experience in diagnostic pathology, histopathology, cytopathology, and pediatric pathology

Qualification & Experience        EXPERIENCE (in Years) : 2–3 years           ELIGIBILITY : GNM / B.Sc. Nursing + ICN Course | Experience: 2–3 years