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0.0 - 1.0 years
2 - 4 Lacs
Hyderabad, Bengaluru
Work from Office
Should have Strong Knowledge in medical review of ICSRs and Pharmacovigilance Knowledge of safety databases, such as Argus, ARISg. Familiarity with medical coding dictionaries (e.g., MedDRA) and adverse event reporting standards (e.g., ICH E2B). Required Candidate profile Conduct thorough and objective medical review of ICSRs received from various sources, including clinical trials, spontaneous reports, and literature. BDS and MBBS Are eligible to apply
Posted 3 weeks ago
0.0 - 1.0 years
2 - 3 Lacs
Hyderabad, Pune, Chennai
Work from Office
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.
Posted 3 weeks ago
0.0 - 1.0 years
2 - 5 Lacs
Hyderabad/Secunderabad, Pune, Bengaluru
Work from Office
Job description Should have knowledge in clinical research studies Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) should have knowledge in ICH GCP Guidelines Required Candidate profile Minimum Bachelor's or Masters degree in related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Are Applicable to Apply
Posted 3 weeks ago
0.0 - 5.0 years
0 Lacs
Bengaluru, Karnataka
On-site
Clinical Medical Manager - Hyderabad Category: Medical Affairs Location: Bangalore, Karnataka, IN Department – Rare Disease - Marketing- Early Launches Are you an experienced medical professional and passionate about Clinical Medical? Does being part of a growing, yet dynamic environment excite you? If yes, then you may be the one we are looking for as Clinical Medical Manager for Novo Nordisk India. Apply now! The position As a Clinical Medical Manager, you will be responsible for : Facilitate the execution of clinical trials related to New Therapy Areas (including CVD, CKD, NASH) by providing medical/scientific expertise and advice. Identify and map KOLs, investigators, and research center’s within the relevant therapy areas. Collect early scientific insights and guidance by discussing relevant early development data with external medical and scientific experts. Contribute to delivering successful clinical trials (phase I-IV) in collaboration with clinical operations. Provide timely medical guidance and internal training to clinical staff. Engage in extensive scientific communication both internally and externally, requiring strong presentation skills. Performing ad hoc visits, Supporting attendance at investigator meetings, ensuring KOL inclusion in clinical trials and engaging key investigators to communicate trial results. Qualifications To be successful in this role, you should have the following qualifications: MD in any discipline with a strong clinical research/medical affairs background. 5 years of clinical or pharmaceutical industry experience with strong experience in human healthcare research either from university, CROs, or pharmaceutical industry. Expertise in therapeutic areas of relevance (CVD, CKD, NASH), preferably with authorship in peer-reviewed journals. Understanding of pharmaceutical drug development. Open to domestic and international travel in connection with site visits, congresses, and company events. Experience as a clinical trial investigator or sub-investigator. Understanding the specificities and nuances of the local healthcare infrastructure. About the department The CMR (Clinical, Medical, Regulatory & Pharmacovigilance) team based in Bangalore. Our team is dedicated to driving clinical trials and providing medical/scientific expertise in New Therapy Areas. We work closely with KOLs, independent professional associations, and patient advocacy associations to ensure the successful execution of clinical trials. The atmosphere is collaborative and dynamic, with a strong focus on scientific excellence and patient outcomes. Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing. Contact To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Internal candidates are kindly requested to inform their line Managers before applying. Deadline 10th June 2025 Disclaimer It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Posted 3 weeks ago
0.0 - 2.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
Site Name: Bengaluru Luxor North Tower Posted Date: May 26 2025 Job Purpose and Key Responsibilities: Provide support for Central Safety Department (CSD) literature screening activities for both ICSR and signal detection purposes in accordance with their procedures and regulatory requirements. Support SERM product specialists by identifying articles of interest for relevant safety information from screened publications for all of GSK’s product portfolio. Perform PV literature surveillance activities according to appropriate regulations and agreed processes Ensure timely production of key deliverables including but not limited to: Screening and review of literature search results (articles/abstracts/citations) for purposes of ICSR identification Triaging literature search results for potential articles of interest with relevant safety information concerning both GSK marketed and GSK products in development, for signal detection/periodic reporting purposes using defined algorithms and criteria. Accountability: Breadth/Scope of Accountability - Number of Direct Reports Number of Indirect Reports 0 0 Complexity (this is best illustrated for this role by the behaviors needed to perform effectively): Decision Making: Developing confidence in making decisions. Makes decisions based on facts, common sense with the support of mentors or manager. Understands and can articulate decision making process. Teamwork: Works effectively with others to achieve business goals and objectives. Bridges personal, business and cultural differences to work effectively in team settings. Communication: Has effective communications with internal audiences, tailoring information appropriately. Responds with confidence to more complex questions using sound judgment. Translates complex science into simple messages that resonate. Competencies: Minimum level of job-related experience required: 0 to 2 years of relevant industry experience Pharmaceutical industry experience (e.g. drug safety (desired), regulatory, clinical development, medical affairs) Working knowledge of key pharmacovigilance regulations and methodologies Good English language skills – written and verbal particularly in scientific/medical terminology Ability to evaluate data and draw conclusions with appropriate guidance from senior team members or manager Good attention to detail. Good interpersonal, presentation and communication skills. Service-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environment. Computer proficiency, IT skills, the expertise and ability to work with web-based applications Good level of flexibility and ability to prioritize work Education: Minimum level of education: Bachelor’s Degree - Life sciences (Biology, chemistry, pharmacy, medicine or other relevant scientific discipline) Preferred level of education: Pharmacy, Medical or pharmacology degrees Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine. 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Posted 3 weeks ago
2.0 - 4.0 years
0 Lacs
Chennai, Tamil Nadu, India
On-site
Job Description As a Therapy Business Manager you will be responsible for the development and performance of all sales strategies in assigned market. Further you will drive primary sales, secondary sales and ensuring brand presence in defined markets. You will supervise/manage the distributor network to achieve desired sales objectives thereby ensuring achievement of financial and ethical objectives of the division as per the business strategy. To achieve this you will have authority to develop your customer management plan, approve expiry products issue credit note for distributors under your control, recommending appointment and credit limits of distributors, develop, execute & plan your resource utilization and participate in Strategy Execution review meetings to ensure alignment. You have a very important role to play in Division's success. Roles and Responsibilities in detail Territory Business Planning: Plan for the monthly and quarterly business. Plan demand generation and fulfillment Monitor actual Sales and mid-course corrections and inputs to reduce variance against expectations Prescription audit for Abbott brands and other competitors brands To create and update customer list having specified number of doctors /chemist (Trade) as per the therapy /product requirement and maintain the same in physical/electronic format. Business generation & development: Achieve monthly, quarterly, half-yearly, and yearly Sales targets by promoting companies products ethically to customers as per the business plan Having science base discussions with doctor and chemist for promotion of the product in the clinic and at the chemist place Organizing Camps (CME) as per the division strategy and customers need Execute the customer management plan to ensure that all the customers are covered as per the plan. Lead and execute strict adherence to Abbott Code of Business conduct Set examples on implementation of the code of business conduct, RCPA, Pharmacovigilance to ensure compliance Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring, and Enduring Ensure a high level of customer service and manage any difficult customer situations. Division and business strategy will be shared with you on time to time base which you will have to execute to the fullest To attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programs, and any other programs undertaken by the company to equip you or activities for the performance of your job or promote the sales of products of the company or to improve company image. Meet minimum KPIs as follows: 100% coverage of Doctors. Customer Call average as per the customer management plan of the division /therapy. Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy /division. Experience/Training Required 2+ Years of experience. Candidate with prior/current experience in the same therapy. Candidates from MNC and top Indian Pharma companies will have added advantages. Fluent and confident in communication. #LI-DNI
Posted 3 weeks ago
4.0 years
0 Lacs
Mumbai, Maharashtra, India
On-site
Job Description Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla Travel: Low Job Overview Responsible for all artworks and labeling components of Piramal Critical Care Products Worldwide with adherence to the labeling processes, ensuring compliance with innovator labeling, internal & external partners, and GMP standards and specifications. Participate in a cross-functional team environment as necessary to ensure labeling documents and associated change requests are medically and scientifically accurate and that they comply with regulatory standards, meet company needs and accurately assess current strategy and global regulations Key Stakeholders: Internal Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Leadership team Key Stakeholders: External Country Distributors, Health Authority (HA), CMOs and external partners Reporting Structure Reports to: Manager – Labelling Essential Qualification Bachelor’ degree or Master’s degree in Pharmaceutical sciences or equivalent Experience 4 years relevant regulatory experience (Global experience including US, EU and major Rest of World markets preferred) Roles And Responsibilities Global labeling details (labels, cartons, package inserts, patient package inserts) to ensure quality and accurate compliance, evaluations, maintenance, reviews and approvals with cross-functional teams for regulatory submissions Preparation of Labelling related documents ex: SmPC, PIL and Labelling texts for submission in EU region. Coordinating with the different stakeholders for timely labeling related submission/approval and query solving. Proofreading all types of label copy/annotation/etc. at all developmental stages as well as final label copy to ensure accuracy of labeling Creation of SPL for US Human and Vet product submissions, drug listing, annual establishment registration and annual self-identification for GDUFA Monitor and process innovator-labeling updates for existing generic products and ensure compliance with innovator updates, including side-by-side comparison with RLDs Responsible for coordination of CCDS development and updates of PCC products and coordination of local labeling updates Contribute to the development and/or review of all labeling aspects included in Promotional Material. Development and maintenance of a central repository for all labeling components Competencies Must have solid interpersonal and organization skills for interfacing with others. Knowledge of Health Authority labeling regulations and requirements. Self-directed, motivated, organized, flexible and accountable. Excellent work ethic with a positive, can-do attitude to succeed in a fast-paced environment. Project management skills is a plus About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders. PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators. Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space. Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment. Show more Show less
Posted 3 weeks ago
0.0 - 1.0 years
4 - 6 Lacs
Kadapa, Tirupati, Nellore
Work from Office
Greetings From Sri Sai Medicode Clinical Data Management Freshers Location - Tirupati Only.. Offline Training With Placement Qualification - Any Life sciences Graduates Only CV's On Mail - srisaimedicode@gmail.com Clinical Research Also
Posted 3 weeks ago
2.0 years
0 Lacs
Greater Kolkata Area
On-site
Job title : Scientific Sales Executive Location: Guwahati Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. PURPOSE OF THE ROLE To achieve the area sales objectives and stretch beyond targets by increasing prescription from identified doctors through effective implementation of marketing activities. To support in organizing patient acquisition and retention programs Internal CSM, RBM, Supply Chain Manager, Product Manager, Assistant Manager – HR (Sales),Zonal OPTIMA coordinator, Zonal Finance, Regional Training Manager External Distributors, Doctors, Chemists, Pharmacovigilance, Sales Director MANAGEMENT / LEADERSHIP RESPONSIBILITY Organization To align with and participate actively in organization led initiatives periodically To understand and comply with the organization Code of Ethics Scope of Role (Team, Geographical, Material) Role based at the respective region assigned KEY RESULT AREAS Work Area Descriptors Performance Indicators People Capability Development - Attend all local and regional meetings and training programs and acquire and apply knowledge as disseminated through such programs. New Hire Induction - Impart field induction training to new joiners monitor progress and give feedback to superiors. Make product presentation and assist area manager in PCM’s whenever required. Assist CSM in collection and summarizing of SLP sales leadership in plan formats. Attendance and participation at local/regional meeting Attendance and participation in training programs/seminar Financial Sales Target Achievement - Achieve monthly, quarterly and annual sales targets as assigned by CSM/RBM Inventory Management - Forwarding of breakage & expiry of products within limits of authority. Customer Acquisition Budget Management - Decide and effectively utilize financial investment for doctors within the ethical guidelines of the group. Target achieved % Growth Process Efficient Day Planning - Plan day’s work with clear objectives for each call, perform pre and post call analysis and visits chemists for feedback. Market Intelligence - Keep track of movement of company products vis-à-vis competitor’s products and give regular feedback to superiors. Assist the CSM to identify appropriate target doctors. Report adverse events to Pharmacovigilance. Effective utilization of SFE tools OPTIMA and SLP guidelines for process excellence. Product Availability - Make the products available, follow-up and coordinate with the chemists and C&F to ensure adequate inventories of company’s products. Call average Frequency of coverage i.e. A & B Accuracy and timeliness of Data entered in OPTIMA Market & competitors feedback to superiors Adverse event reporting Customer Brand Building - Organize specific group events of doctors – organize logistics e.g. venue, date, & time, materials, etc. and co-ordinate with executive/product manager in compliance with the ethical framework of the company. Participate in the patient acquisition and retention campaigns, where applicable. Give post program feedback; follow up with participating doctors to increase demand. Inventory level recording Quality, timeliness and effectiveness of events organized % growth in patient acquisition and retention Feedback from retailers, distributors Role – Holder Entry Requirements Minimum Educational Qualification Any Graduate, preferably B.Sc or B.Pharm Relevant Work Experience Minimum Years Of Experience 2+ years of relevant experience Preferred Industry Experience Pharmaceuticals, Consumer Health Care Functional Knowledge Required Product Knowledge Knowledge of pharma industry Basic Financial Management Knowledge Skills Required Excellent oral and verbal communication skills Basic use of MS Office Business Acumen and entrepreneurial traits Influencing and negotiation skills Desired Competencies Act for Change Think strategically Strive for Results Lead Teams Commit to Customers Make Decisions Cooperate Transversally Develop People CAREER DEVELOPMENT OPPORTUNITIES The career path for the role can be vertically towards the Channel Sales Manager role Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We Are Dedicated To Making Self-care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers Show more Show less
Posted 3 weeks ago
2.0 years
0 Lacs
Kolkata, West Bengal, India
On-site
Job title : Scientific Sales Executive Location: Patna Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. PURPOSE OF THE ROLE To achieve the area sales objectives and stretch beyond targets by increasing prescription from identified doctors through effective implementation of marketing activities. To support in organizing patient acquisition and retention programs Internal CSM, RBM, Supply Chain Manager, Product Manager, Assistant Manager – HR (Sales),Zonal OPTIMA coordinator, Zonal Finance, Regional Training Manager External Distributors, Doctors, Chemists, Pharmacovigilance, Sales Director MANAGEMENT / LEADERSHIP RESPONSIBILITY Organization To align with and participate actively in organization led initiatives periodically To understand and comply with the organization Code of Ethics Scope of Role (Team, Geographical, Material) Role based at the respective region assigned KEY RESULT AREAS Work Area Descriptors Performance Indicators People Capability Development - Attend all local and regional meetings and training programs and acquire and apply knowledge as disseminated through such programs. New Hire Induction - Impart field induction training to new joiners monitor progress and give feedback to superiors. Make product presentation and assist area manager in PCM’s whenever required. Assist CSM in collection and summarizing of SLP sales leadership in plan formats. Attendance and participation at local/regional meeting Attendance and participation in training programs/seminar Financial Sales Target Achievement - Achieve monthly, quarterly and annual sales targets as assigned by CSM/RBM Inventory Management - Forwarding of breakage & expiry of products within limits of authority. Customer Acquisition Budget Management - Decide and effectively utilize financial investment for doctors within the ethical guidelines of the group. Target achieved % Growth Process Efficient Day Planning - Plan day’s work with clear objectives for each call, perform pre and post call analysis and visits chemists for feedback. Market Intelligence - Keep track of movement of company products vis-à-vis competitor’s products and give regular feedback to superiors. Assist the CSM to identify appropriate target doctors. Report adverse events to Pharmacovigilance. Effective utilization of SFE tools OPTIMA and SLP guidelines for process excellence. Product Availability - Make the products available, follow-up and coordinate with the chemists and C&F to ensure adequate inventories of company’s products. Call average Frequency of coverage i.e. A & B Accuracy and timeliness of Data entered in OPTIMA Market & competitors feedback to superiors Adverse event reporting Customer Brand Building - Organize specific group events of doctors – organize logistics e.g. venue, date, & time, materials, etc. and co-ordinate with executive/product manager in compliance with the ethical framework of the company. Participate in the patient acquisition and retention campaigns, where applicable. Give post program feedback; follow up with participating doctors to increase demand. Inventory level recording Quality, timeliness and effectiveness of events organized % growth in patient acquisition and retention Feedback from retailers, distributors Role – Holder Entry Requirements Minimum Educational Qualification Any Graduate, preferably B.Sc or B.Pharm Relevant Work Experience Minimum Years Of Experience 2+ years of relevant experience Preferred Industry Experience Pharmaceuticals, Consumer Health Care Functional Knowledge Required Product Knowledge Knowledge of pharma industry Basic Financial Management Knowledge Skills Required Excellent oral and verbal communication skills Basic use of MS Office Business Acumen and entrepreneurial traits Influencing and negotiation skills Desired Competencies Act for Change Think strategically Strive for Results Lead Teams Commit to Customers Make Decisions Cooperate Transversally Develop People CAREER DEVELOPMENT OPPORTUNITIES The career path for the role can be vertically towards the Channel Sales Manager role Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We Are Dedicated To Making Self-care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers Show more Show less
Posted 3 weeks ago
10.0 years
0 Lacs
Ankleshwar, Gujarat, India
On-site
MISSION STATEMENT We are a Corporate quality team governing major and critical quality incidents requiring escalation - we drive the assessments of quality issues raised within Zentiva product supply and commercial operation to ensure appropriate escalation, notification, categorization, mitigation, and health authority reporting, as well as consistency in assessment and documentation for all quality incidents. Our team is in liaison between quality and commercial / business stakeholders to ensure satisfactory management of quality issues. We ensure implementation of corporate quality system requirements , tools and procedures at affiliate quality management systems (QMS) including its evaluation, as well as communication and training within Zentiva organization. Main Accountabilities And Duties Key point of contact for information on escalation process and determination of issue criticality and categorization of issues, subsequent steps, and mitigating actions. Identifying stakeholders for discussion and decision making incase of escalations and manage the escalation meeting including the issuance of meeting minutes. Develop and maintain Guidelines / SOPs for escalation management including templates for investigation report, presentations, meeting minutes, and HA notifications. Ensure event record is raised, maintained, and completed in a timely manner meeting Good Documentation Practices and per processes for incidents in scope escalation management team. Update the organization with new regulations / requirements applicable to Genotoxic Impurities (Eg. Nitrosamine Impurities) and oversees the activities within Quality organization. Coordinates review and approvals of procedures, methods, analytical method validations with external or internal laboratories, risk assessments, investigation reports, change requests, etc with respect to Nitrosamine Impurities. Standardize the management of Genotoxic impurities management and improvise if needed. As an escalation process SME, drive timelines for process steps. Lead and manage Health Authority reporting as needed to ensure reporting is completed in a compliant manner. Support completion of monthly escalation updates on escalations (incidents). Develop and maintain a network of key stakeholders in Zentiva to ensure appropriate input and support of quality issues. Lead active surveillance and analysis of emerging regulations, suspension of EU GMPc & warning letters, perform impact assessments and drive process changes required to ensure ongoing compliance to regulatory requirements. Analyze the impact of other Zentiva processes and organizational changes on assigned processes. Develop and maintain Guidelines / SOPs for regulatory surveillance process. Assess and comment escalation before communication to target markets authorities and customers. Assure assessment and benchmark of similar cases among sites and affiliates to minimize duplicity in investigation and improve overall effectiveness. SME and provide support in case of authority inspections at market level. Prepare regular reporting in respective area. Establish KPIs and ensure KPIs are met for escalation (Genotoxic & other escalations) and for Regulatory Surveillance. Other Responsibilities QUALITY: Adheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy. HSE: Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System. PHARMACOVIGILANCE: All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations. COMPLIANCE: The employee will comply with all internal rules of the Company, mainly with the Working Order of the Company and all other internal rules specifying the provisions of the Working Order. The employee will make her/himself acquainted with the Code of Ethics (Zentiva “Code of Common Senses”) and will comply with the principles stated therein and in all related policies and other internal documents. SUSTAINABILITY: Adheres to the principles of ESG detailed in the Sustainability Strategy and its 3 pillars People, Partners and the Planet. MANAGERIAL POSITION REQUIREMENT: Good communication and adaptability to different portfolio projects and acquisitions, leadership of transversal teams in quality, participation in transversal project/acquisition teams, good planning, quick learning, broad quality knowledge, systematic tracking. Required Qualifications, Experience & Skills Technical University Degree (health, pharma, technical, chemical areas are advantage). 10+ years industry experience specifically in GxP with a strong understanding of international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable. Strong experience in area of GxP related to change control, deviation, quality processes and document management. Organizational and analytical skills associated with a proficiency in quality management and continuous improvement. Critical thinking ability and risk management and risk- based knowledge and approach. Ability in partnering with a proactive and solution- oriented approach. Strong skills to facilitate/optimize contribution of team members as individuals and members of a quality function. Ability to work effectively in a matrix cross-functional environment. Strong capacity for working independently with minimal supervision. Ability to make & communicate difficult decisions, associated with strong written and verbal communication skills. (English language in writing and speaking). Self-awareness, willingness to further develop own strengths and explore opportunities for improvement. What Is In It For You An opportunity to work for a successful international pharmaceutical company. An opportunity to learn newest approaches in managing creative and highly adaptive business organizations. Pleasant and dynamic working environment. Continuous personal development. An attractive compensation & benefits package. Above standard social and benefit program. Show more Show less
Posted 3 weeks ago
0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Pharmacovigilance Reporting Associate to join our diverse and dynamic team. As a Senior Pharmacovigilance Reporting Associate at ICON, you will be essential in ensuring accurate and timely reporting of safety data related to pharmaceutical products. You will work closely with cross-functional teams to enhance the organization’s pharmacovigilance reporting processes and maintain compliance with regulatory standards. What You Will Be Doing Preparing and submitting adverse event reports and safety data in accordance with regulatory requirements and internal policies, ensuring accuracy and completeness. Collaborating with clinical and regulatory teams to review and analyze safety data, identifying trends and potential safety signals for further investigation. Assisting in the preparation of periodic safety update reports (PSURs), annual reports, and other regulatory documents to ensure compliance with reporting obligations. Monitoring timelines for safety report submissions and proactively managing any delays or issues that may arise in the reporting process. Maintaining and updating pharmacovigilance databases, ensuring the integrity and quality of safety data through meticulous data entry and validation. Providing training and support to junior team members on reporting procedures and pharmacovigilance regulations to enhance team capabilities. Engaging in audits and inspections by regulatory authorities, ensuring readiness and adherence to all relevant pharmacovigilance reporting requirements. Staying informed about changes in regulatory guidelines and industry standards to ensure ongoing compliance and best practices in pharmacovigilance reporting. Your Profile Bachelor’s degree in life sciences, pharmacy, or a related field. An advanced degree is preferred. Extensive experience in pharmacovigilance or drug safety reporting, with a strong understanding of relevant regulations and guidelines. Proven ability to prepare and submit accurate adverse event reports and safety data in a timely manner. Strong analytical skills, with the ability to interpret safety data and identify trends or issues requiring further action. Excellent communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams. Proficiency in pharmacovigilance databases and reporting tools, as well as Microsoft Office Suite. Ability to manage multiple projects and priorities in a fast-paced environment while maintaining attention to detail. Commitment to maintaining confidentiality and handling sensitive patient information with discretion. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply Show more Show less
Posted 3 weeks ago
3.0 - 8.0 years
3 - 6 Lacs
Hyderabad
Work from Office
The Manager, CSAR - SAS Edit Check Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Edit check programming activities. The Manager, CSAR - SAS Edit Check Programmer will create and implement edit checks, adhering to Amgen standards, procedures, and best practices using SAS programming. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Edit Check Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following Support of clinical trial platform technologies? Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams ? Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating/programming complex SAS edit checks according to specifications, testing them for functionality and identify potential issues before implementation. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice ? Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes? Data management processes? Programming of clinical trial databases and applications? Proficient in SAS edit check programming Systems development lifecycle? Programming Languages ? Project planning and management? Collaborating with global cross-functional teams (team/matrix environment) Quality management? and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline? with 9-13 years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena? Proven experience in managing teams General project management and planning experience ? Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related discipline ?with 9-13 years of experience Proven experience in managing teams Specialist knowledge / experience in life sciences or a medically related field? General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
Posted 3 weeks ago
2.0 - 7.0 years
4 - 9 Lacs
New Delhi, Gurugram
Work from Office
We are looking for a highly skilled and experienced Operations Analyst to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2 to 7 years of experience in document verification and be able to work efficiently in a fast-paced environment. Roles and Responsibility Verify documents for accuracy and completeness. Perform quality checks on verified documents. Collaborate with the operations team to resolve issues. Develop and implement process improvements to increase efficiency. Maintain high customer satisfaction through excellent service. Ensure compliance with regulatory requirements. Job Requirements Minimum 2 years of experience in document verification or a related field. Strong knowledge of document verification processes and procedures. Excellent analytical and problem-solving skills. Ability to work effectively in a team environment. Strong communication and interpersonal skills. Familiarity with operational analysis and process improvement techniques.
Posted 3 weeks ago
1.0 - 4.0 years
1 - 4 Lacs
Mysuru, Bengaluru
Work from Office
We are looking for a highly motivated and experienced Business Development Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 1-4 years of experience in the BFSI industry. Roles and Responsibility Develop and implement effective business strategies to achieve sales targets. Build and maintain strong relationships with clients and stakeholders. Identify new business opportunities and expand existing customer relationships. Collaborate with cross-functional teams to drive business growth. Analyze market trends and competitor activity to stay ahead in the market. Provide excellent customer service and support to ensure high levels of customer satisfaction. Job Requirements Strong understanding of the BFSI industry and its regulations. Excellent communication, interpersonal, and negotiation skills. Ability to work in a fast-paced environment and meet deadlines. Strong analytical and problem-solving skills with attention to detail. Experience in sales and marketing with a proven track record of success. Ability to build and maintain strong relationships with clients and stakeholders.
Posted 3 weeks ago
5.0 - 10.0 years
1 - 5 Lacs
Hyderabad, Chennai
Work from Office
We are looking for a highly skilled and experienced Branch Manager to lead our team in Equitas Small Finance Bank Ltd. The ideal candidate will have a strong background in BFSI, with 5-10 years of experience. Roles and Responsibility Manage daily branch operations, ensuring efficient use of resources and adherence to regulatory requirements. Develop and implement strategies to achieve business objectives, including sales growth and customer acquisition. Lead and motivate a team of banking professionals, providing guidance on product knowledge and customer service standards. Build and maintain relationships with key stakeholders, including customers, colleagues, and external partners. Monitor and control expenses, ensuring cost-effectiveness without compromising quality or service delivery. Identify opportunities for process improvements, implementing changes to increase productivity and efficiency. Job Requirements Strong understanding of BFSI industry trends, regulations, and best practices. Excellent leadership and management skills, with the ability to inspire and guide teams. Proven track record of achieving business objectives through strategic planning and execution. Strong analytical and problem-solving skills, with attention to detail and accuracy. Effective communication and interpersonal skills, enabling building strong relationships with stakeholders. Ability to work in a fast-paced environment, prioritizing tasks and managing multiple responsibilities.
Posted 3 weeks ago
3.0 - 5.0 years
1 - 5 Lacs
Hindupur, Kurnool
Work from Office
We are looking for a highly skilled and experienced Field Risk Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 3-3 years of experience in the BFSI industry. Roles and Responsibility Conduct risk assessments and evaluations to identify potential threats to the organization. Develop and implement effective risk management strategies to mitigate identified risks. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Analyze market trends and competitor activity to inform business decisions. Identify and report on key performance indicators (KPIs) to senior management. Provide expert guidance on risk management best practices to stakeholders. Job Requirements Strong understanding of risk management principles and practices. Excellent analytical and problem-solving skills with attention to detail. Ability to work effectively in a fast-paced environment with multiple priorities. Strong communication and interpersonal skills, with the ability to build relationships with stakeholders. Experience working with financial data and systems, including risk management software. Strong knowledge of regulatory requirements and industry standards related to risk management.
Posted 3 weeks ago
3.0 - 8.0 years
1 - 5 Lacs
Hubli, Basavakalyan
Work from Office
We are looking for a highly skilled and experienced Branch Receivable Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 3 to 8 years of experience in the BFSI industry, with expertise in managing receivables and driving business growth. Roles and Responsibility Manage and oversee the daily operations of the branch's receivable functions. Develop and implement strategies to improve collection efficiency and reduce delinquencies. Collaborate with cross-functional teams to identify and mitigate potential risks. Analyze and report on key performance indicators (KPIs) related to receivables and collections. Ensure compliance with regulatory requirements and internal policies. Lead and motivate a team of professionals to achieve business objectives. Job Requirements Strong knowledge of BFSI regulations and practices. Proven experience in managing receivables and driving business growth. Excellent leadership and communication skills. Ability to analyze complex data sets and make informed decisions. Strong problem-solving and negotiation skills. Experience working in a fast-paced environment and meeting deadlines.
Posted 3 weeks ago
1.0 - 6.0 years
2 - 6 Lacs
Kochi
Work from Office
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.
Posted 3 weeks ago
0.0 - 3.0 years
2 - 3 Lacs
Tirupati
Work from Office
Roles and Responsibilities Provide training on clinical data management, medical coding, pharmacovigilance, and regulatory affairs to clients. Conduct workshops and webinars on drug regulatory affairs and pharma marketing topics. Develop customized training materials and presentations for clients. Collaborate with cross-functional teams to deliver high-quality training programs.
Posted 3 weeks ago
5.0 - 7.0 years
2 - 7 Lacs
Kumbakonam, Mannargudi, Thiruvarur
Work from Office
We are looking for a skilled Branch Receivable Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 5-7 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the daily operations of the branch's receivables. Develop and implement strategies to improve collection efficiency and reduce delinquencies. Collaborate with cross-functional teams to resolve customer complaints and issues. Analyze financial data to identify trends and areas for improvement in receivables management. Ensure compliance with regulatory requirements and internal policies. Train and guide junior staff members on receivables procedures and best practices. Job Requirements Strong knowledge of accounting principles and financial regulations. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and meet deadlines. Proficiency in MS Office and other relevant software applications. Strong analytical and problem-solving skills. Experience in managing and leading a team of professionals.
Posted 3 weeks ago
0.0 - 5.0 years
1 - 3 Lacs
Nagpur, Buldana, Akola
Work from Office
We are looking for a highly motivated and experienced Branch Receivable Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 0-6 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the daily operations of the branch's receivables, ensuring timely payments and minimizing bad debts. Develop and implement effective strategies to improve cash flow and reduce outstanding amounts. Collaborate with the collections team to identify and resolve issues related to delayed payments. Analyze financial data to provide insights on customer behavior and areas for improvement. Maintain accurate records and reports on receivables, including aging analysis and credit risk assessments. Ensure compliance with regulatory requirements and internal policies related to receivables management. Job Requirements Strong knowledge of accounting principles, financial regulations, and banking practices. Excellent communication, interpersonal, and problem-solving skills. Ability to work in a fast-paced environment and meet deadlines. Proficiency in MS Office and other relevant software applications. Strong analytical and decision-making skills with attention to detail. Experience working in a similar role within the BFSI industry is preferred. Location - Buldana,Akola,Nagpur,Nashik
Posted 3 weeks ago
1.0 - 5.0 years
2 - 4 Lacs
Bengaluru
Work from Office
We are looking for a highly motivated and experienced Branch Operations Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2 to 7 years of experience in the BFSI industry. Roles and Responsibility Manage daily branch operations, ensuring efficient workflow and customer satisfaction. Supervise and coordinate with branch staff to achieve operational goals. Develop and implement strategies to improve branch performance and productivity. Maintain high standards of customer service, resolving complaints and queries promptly. Ensure compliance with regulatory requirements and internal policies. Analyze operational data to identify areas for improvement and optimize processes. Job Requirements Minimum 2 years of experience in branch operations or a related field. Strong knowledge of BFSI operations, regulations, and procedures. Excellent communication, leadership, and problem-solving skills. Ability to work in a fast-paced environment, prioritizing tasks effectively. Proficient in Microsoft Office and other operational software. Strong analytical and decision-making skills with attention to detail.
Posted 3 weeks ago
2.0 - 5.0 years
1 - 3 Lacs
Chennai
Work from Office
We are looking for a highly skilled and experienced Operations Analyst to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-5 years of experience in document verification, with a strong background in BFSI operations. Roles and Responsibility Analyze and verify documents for accuracy and completeness. Collaborate with internal teams to resolve document-related issues. Develop and implement process improvements to enhance efficiency. Maintain accurate records and reports of document verification activities. Identify and mitigate potential risks associated with document verification. Ensure compliance with regulatory requirements and industry standards. Job Requirements Strong knowledge of BFSI operations and document verification processes. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environment. Strong communication and collaboration skills. Proficient in Microsoft Office and other relevant software applications. Experience working with financial institutions or similar industries is preferred.
Posted 3 weeks ago
3.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description As part of the Clinical Development team at Azurity, the Clinical Development Manager, is primarily responsible for supporting departmental activities including but not limited to clinical trials (phase 1 to phase 4), conducting targeted scientific analyses for projects across therapeutic areas for nonclinical and clinical programs at Azurity. In this role, the candidate will report to the Associate Director, Clinical Development. Principle Responsibilities This should specifically outline, in bullet form, the responsibilities of the job: Ability to understand integrated data (formulation, pharmacokinetics/genomics, pharmacodynamics, pharmacovigilance, etc.) from clinical trials, treatment guidelines, and other resources to provide scientific evaluations and develop risk assessments. Provides operational and scientific oversight of nonclinical and clinical studies from study design to study closeout ensuring GCP/ICH/regulatory compliance of study documents, processes and procedures. Author study documents, including protocols, consents, management plans, amendments, etc. Review of CRO/3rd party documents (e.g., SOPs, CRFs, EDC, TFLs, etc.) to ensure alignment with Azurity’s quality expectations and SOPs, if needed. Drafting responses to competent authorities or ethical committees. Vendor and site monitoring. Identify logistical/scientific/ethical/regulatory hurdles/risks and propose solutions. Provide clinical updates on assigned programs. Identify key scientific sources/findings to support clinical development contributions to regulatory communications (e.g., meeting requests, briefing books, IND/NDA submissions, annual reports, etc.) Identify KOLs, external experts/consultants across diverse therapeutic areas to contribute to clinical development objectives. Draft abstracts, posters, oral presentations, and manuscripts. Contribute to process improvement initiatives within clinical development or in collaboration with other functions. Facilitate contractual requirements (CDAs, MSAs, etc.) for clinical development projects in collaboration with applicable Azurity functions. Collaborate with PM function to ensure visibility of project deliverables. Qualifications And Education Requirements This section should include relevant qualifications and education requirements. Degree in scientific/life-sciences field, Master’s degree preferred. 3+ years of experience in clinical development or related role within the pharmaceutical, biotechnology or CRO industry. Working knowledge of clinical research, GCP, GLP, ICH, and FDA regulations. Understanding of pharmaceutical drug lifecycle preferred. Strong communication skills (both written and verbal) with an ability to express complex information clearly and concisely. Exceptional analytical and problem-solving skills. Experience in analysis of research data and publications. Demonstrates passion for research and willingness to learn. Brings innovation and creativity to challenging projects. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less
Posted 3 weeks ago
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Pharmacovigilance, also known as drug safety, is a crucial aspect of the healthcare industry that focuses on monitoring and assessing the safety of pharmaceutical products. In recent years, there has been a growing demand for pharmacovigilance professionals in India as the pharmaceutical sector continues to expand. Job seekers looking to explore opportunities in pharmacovigilance in India can expect a competitive job market with promising career prospects.
These cities are known for their concentration of pharmaceutical companies and research institutions, making them hotspots for pharmacovigilance job opportunities.
The average salary range for pharmacovigilance professionals in India varies based on experience and location. Entry-level positions typically start at around INR 3-5 lakhs per annum, while experienced professionals can earn upwards of INR 10-15 lakhs per annum.
In pharmacovigilance, a typical career progression may include roles such as Drug Safety Associate, Drug Safety Specialist, Pharmacovigilance Scientist, Pharmacovigilance Manager, and Pharmacovigilance Director. As professionals gain experience and expertise, they may move into leadership positions with increased responsibilities.
In addition to pharmacovigilance expertise, professionals in this field are often expected to have knowledge of regulatory guidelines, data analysis skills, medical terminology, and effective communication abilities.
As you prepare for pharmacovigilance job opportunities in India, remember to showcase your expertise, relevant skills, and passion for drug safety. Stay updated with industry trends and regulations, and approach interviews with confidence. With the right preparation and determination, you can embark on a rewarding career in pharmacovigilance in India. Good luck!
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