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2.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
About The Job Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main Responsibilities Write and/or edit under guidance high-quality safety documents, medical section of Periodic Benefit-Risk Evaluation Report, medical sections of Addendum to clinical overview, Disease and Product ID Cards, product alerts and trial transparency documents. Delivery of high-quality medical documents in time and in compliance with internal and external standards and guidelines. Essential job duties and responsibilities: 1) Participate with support in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 2) Develops and maintains TA expertise. 3) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs teams based on the documents assigned. People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise. Performance: Provide deliverables (PBRER, ACO, Product and Disease ID Cards, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality. Process: 1) Author, review, and act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis. 3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. 6) Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts. 7) Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. 8) Remain abreast of Sanofi Policy or Quality Documents evolution. Stakeholders: 1) Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Legal/Regulatory/corporate affairs departments to prepare relevant & customized deliverables. About You Experience: >2 years of experience in regulatory writing for the pharmaceuticals/healthcare industry Soft skills: Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment. Technical skills: As applicable (including but not limited to time, and risk management skills, Excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applications) Education: Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters or bachelor’s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD) Languages: Excellent English language knowledge (to read, write and speak) null Show more Show less
Posted 1 week ago
1.0 - 2.0 years
0 Lacs
Jai Singh Road, Delhi, India
On-site
Site Name: India - New Delhi Jai Singh Posted Date: Jun 6 2025 Job Purpose: Provide scientific and technical expertise of the highest standards for local medical information, including interactions with Key External Experts (KEEs) and Key Opinion Leaders (KOLs) Provide medical and scientific input and information for business strategy for the region. Key Responsibilities : Develop and sustain credible networking with appropriate Health Care Practitioners (HCPs) Plan, facilitate and conduct CMEs, symposia, trainings, workshops, scientific meetings, speaker tours, and other product specific campaigns and deliver scientific presentations with consistent messages for key products at these meetings, as required. Support and deliver scientific presentations with consistent “on label” messages at medical education meetings. Understand principles of and support Scientific Engagement (SE) activities as per Medical Plans. Have clarity in understanding on Scientific Engagements and Promotional Code. Become an expert in oncology where GSK have brands and support associated activities related to those brands. Be updated on scientific knowledge on oncology; GSK molecules and its PI to ensure its ‘On Label’ communications on various platforms. Support in feasibility assessment of potential research sites, develop concept notes, proposals, budgets, data collection and monitoring tools for field studies. Provide medical inputs into development and execution of brand strategy. Pharmacovigilance: Support Named Safety contact in strengthening of oncology Pharmacovigilance; ensure self-learning. Knowledge/ Education / Previous Experience Required Educational Background :- Minimum Level of Education - MBBS with post graduate qualification Preferred Level of Education - Post graduate qualification in Pharmacology / Public Health Why is this Level of Education Preferred - To interact with specialized HCPs Job-Related Experience:- Minimum Level Of Job-Related Experience Required Excellent written and oral communication skills in English, local language Experience of presenting scientific topics at different settings A sound understanding of the principles and practice of ICH-GCP and internal SOPs. Well-demonstrated ability to understand scientific methods and experimental design. 1-2 years in the pharmaceutical industry preferably in the oncology therapy area. Other Job-Related Skills/Background:- General Competencies Presentation skills at Scientific meetings Communication skills, both verbal and written Technical writing skills Keep up to date with new developments Ability to provide and receive constructive feedback Build and maintain relationships with colleagues Share knowledge with other team members Work as part of a team to reach common goals Deliver creative ideas for continuous improvement Develop good relationships with key opinion leaders 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 1 week ago
1.0 - 6.0 years
15 - 27 Lacs
Mumbai
Work from Office
SUMMARY Job Title: SAR & SAR-like Patient Safety Physician Reporting To: Patient Safety Physician SAR & SAR-like Coordinator Minimum Educational Qualifications and Experience Required Skills Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Operational Responsibilities Compile PBRERs with a focus on medical aspects and safety sections of products, and analyze safety trends, including source data analysis based on queries Assist in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborate with Therapeutic Head to identify signals and address product safety concerns Engage with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensure 100% compliance with timely completion of all client and Cognizant required trainings Achieve 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities
Posted 1 week ago
5.0 - 10.0 years
5 - 15 Lacs
Mumbai
Work from Office
SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Competencies Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Experience Relevant educational background and experience in patient safety or related field Required Skills Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities
Posted 1 week ago
0.0 - 2.0 years
1 - 4 Lacs
Chennai
Work from Office
Hubra Pharmaceuticals Pvt Ltd is looking for Billing Staff (fresher and experienced) to join our dynamic team and embark on a rewarding career journey Process and manage billing transactions Ensure accuracy of invoices and payments Address customer inquiries and resolve billing issues Maintain billing records and documentation Collaborate with finance and accounting teams Prepare billing reports and statements
Posted 1 week ago
2.0 - 7.0 years
7 Lacs
Hyderabad
Work from Office
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 Divisions 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. LOCATION: India > Hyderabad : No 1-6-140 t
Posted 1 week ago
3.0 - 8.0 years
2 - 5 Lacs
Kolkata
Work from Office
1. Clinical Trial Design and Oversight, 2. Drug Efficacy and Safety Analysis, 3. Drug Interactions and Adverse Reactions, 4. Research and Development, 5. Compliance and Regulatory Affairs, 6. Patient Counseling, 7. Monitoring Drug
Posted 1 week ago
1.0 - 5.0 years
1 - 3 Lacs
Vijayawada, Eluru, Bhimavaram
Work from Office
We are looking for a highly skilled and experienced Receivable Executive to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 1-5 years of experience in the BFSI industry. Roles and Responsibility Manage and maintain accurate records of receivables, including invoices, payments, and outstanding balances. Develop and implement effective strategies to improve cash flow and reduce delinquencies. Collaborate with cross-functional teams to resolve customer complaints and disputes. Analyze financial data to identify trends and areas for improvement in receivable management. Ensure compliance with regulatory requirements and internal policies related to receivables. Provide excellent customer service to clients, responding promptly to their queries and concerns. 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 with multiple priorities and deadlines. Proficiency in MS Office and other relevant software applications. Strong analytical and organizational skills with attention to detail and accuracy. Experience working with receivables, including invoicing, payment processing, and collections.
Posted 1 week ago
0 years
0 Lacs
Gurgaon, Haryana, India
On-site
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Role The purpose of the Affiliate Regulatory Affairs role is to manage the operational and technical aspects of regulatory affairs for the marketing affiliate, including: Execute the Regulatory Plan to ensure the success of new product registration, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and quality system requirements. Foster an environment of operational excellence and collaborate with cross-functional teams to successfully achieve Affiliate regulatory objectives. Facilitate and cultivate relationships with the local regulatory agency/MoH. 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 your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Regulatory Plan Execution Implement the Regulatory Plan in alignment with affiliate business plans as well as regulatory requirements. Ensure submission and approval of high quality regulatory applications within planned timelines. Maintain or support maintenance of clear metrics for Regulatory deliverables. Preparation and support of new applications to obtain marketing authorisations. Voicing affiliate perspective and needs to global and regional regulatory contacts. Ensuring timely responses to requests from support groups and/or Regulatory Authorities. Maintaining marketing authorisations (timely submission of post approval maintenance activities like renewals, variations and periodic reports) Maintain Regulatory Tools in alignment with defined compliance metrics. Support Affiliate launch Teams anticipating potential regulatory constraints and delivering regulatory outcomes to support the affiliate launch plans. Represent the Regulatory Affairs function as appropriate in Affiliate Lead Team and New Product Planning discussions Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally. Facilitate interactions with regulatory bodies on a regular basis. Regulatory Compliance Ensure that internal Regulatory IT tools are up to date and accurate. Ensure that all products comply with local regulations and quality system requirements whichever is more stringent. Ensure that the regulatory archive is complete and up-to-date and that all current licenses and labels are readily available. Ensure implementation of local quality system in line with the global quality system and local regulations. Support internal and external audits / assessments / self-inspections in collaboration with Regulatory Quality personnel. Implement corrective/preventive actions as appropriate. Provide regulatory quality oversight for Third Parties (i.e. Regulatory Services Providers, Translators, Graphic Agencies, etc.) as appropriate. Raise awareness to leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functions. Labelling Perform the function of Primary, Alternate or Delegate Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information complies with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or MOH timelines. Follow global labelling procedures and document relevant exceptions in order to produce accurate and high quality Product Information which is in compliance with global core labeling Process Improvement Ensure alignment and implementation of internal regulatory initiatives. Actively participate in affiliate cross-functional teams and provide regulatory input and knowledge. Support implementation of launch readiness initiatives. Build and maintain relationships with key regulatory officials (External Influence). Provide affiliate training and education on regulatory matters and provide regulatory input to affiliate strategic initiatives. Personal and Professional Development Knowledge and understanding of local regulations and local, regional and global regulatory procedures. Attend appropriate external symposia, workshops or conferences to develop technical expertise Optional Responsibilities: This section is intended to provide additional responsibilities the position may require depending on the Affiliate structure and/or local requirements. Consult with your supervision regarding these additional responsabilities in order to confirm which ones apply to this position. It may apply all or some of them. Note: If the individual undertakes actual responsibilities as Pharmacovigilance Responsible person or Product Quality Representative, then the relevant functional Job Description should be followed Patient Safety Assist the Affiliate Pharmacovigilance Responsible Person in reporting received Adverse Events and submitting expedited and periodic safety reports to the Agency/MoH as per local regulations. Product Quality Assist the Product Quality Representative with the implementation and execution of Lilly Global Quality Standards in particular GQS-181/CQP-181 in the affiliate. Identify and support Product Quality tasks and, in collaboration with the Product Quality Representative, act as the local Quality contact. Support the Product Complaint system as local Responsible Complaint person. Minimum Qualification Requirements Bachelor's degree or equivalent in a relevant scientific subject At least one year industry related experience in regulatory affairs and experience of dealing with external regulatory agencies, the health care system and marketing needs. Team working skills with special focus on results. Ability to adapt to challenging situations. Demonstrated good computer/IT skills. Good knowledge of written and spoken English. Other Information/Additional Preferences Analytical, problem solving and negotiation skills. Good communication skills. Project management skills. Strong planning and priority setting. Good capability to establish positive networking both internally and externally. Strong knowledge of quality systems. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly Show more Show less
Posted 1 week ago
1.0 - 2.0 years
0 Lacs
Mumbai, Maharashtra, India
On-site
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us. Your Role Generate or convert doctors for our product portfolio. Secondary sales – Ensuring to achieve secondary sales targets through prescription generation by each of his BE. Good at relationship with KOLs (Top Physicians, Endocrinologists & Cardiologists) Day to day sales reporting Effective query handling and customer queries. Ensuring 100% Implementation of Company’s strategies Pharmacovigilance (Adverse Event Reporting) – To collect adverse drugs reaction (ADR) incidences including lack of efficacy related to medicinal products up to the maximum possible level of completeness and forward to local Patient Safety team immediately within 24 hours of ADR awareness. The additional information can be submitted as soon as possible Who You Are Any graduate Freshers or minimum of 1-2 years of experience in any pharma company Should have strong product knowledge & communication skills What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team! Show more Show less
Posted 1 week ago
5.0 - 7.0 years
0 Lacs
Gurgaon, Haryana, India
On-site
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Manager/Senior Manager Pharmacovigilance Location: India, Bangladesh, Nepal, Sri Lanka Job Summary: We are seeking a highly skilled and experienced Manager/Senior Manager Pharmacovigilance to oversee and manage pharmacovigilance activities across India, Bangladesh, Nepal, and Sri Lanka. The ideal candidate will ensure compliance with regulatory requirements, manage safety data, and maintain the highest standards of drug safety. Key Responsibilities Oversee pharmacovigilance activities and ensure compliance with local and international regulations. Manage the collection, assessment, and reporting of adverse drug reactions (ADRs) and other safety data. Develop and implement pharmacovigilance processes and procedures. Lead and mentor a team of pharmacovigilance professionals. Collaborate with cross-functional teams, including clinical, regulatory, and quality assurance. Prepare and submit periodic safety update reports (PSURs) and other regulatory documents. Conduct risk assessments and develop risk management plans. Stay updated with the latest pharmacovigilance regulations and guidelines. Liaise with regulatory authorities and external stakeholders as needed. Qualifications Bachelor’s degree in Pharmacy, Medicine, or a related field. Advanced degree preferred. Minimum of 5-7 years of experience in pharmacovigilance, with at least 2 years in a managerial role. In-depth knowledge of pharmacovigilance regulations and guidelines in India, Bangladesh, Nepal, and Sri Lanka. Strong leadership and team management skills. Excellent communication and interpersonal skills. Ability to work effectively in a multicultural environment. Proficiency in pharmacovigilance databases and software. Preferred Skills Experience in handling pharmacovigilance activities for multiple countries. Certification in pharmacovigilance or related fields. Strong analytical and problem-solving skills. Ability to manage multiple projects and deadlines. Benefits Competitive salary and benefits package. Opportunities for professional growth and development. Collaborative and inclusive work environment. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly Show more Show less
Posted 1 week ago
5.0 - 8.0 years
1 - 3 Lacs
Pallavaram, Chennai, Kanchipuram
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 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the branch's receivable portfolio, 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 resolve customer issues and enhance overall customer satisfaction. Analyze financial data to identify trends and areas for improvement in the bank's receivable operations. 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 effectively 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.
Posted 1 week ago
1.0 - 2.0 years
0 Lacs
Mumbai, Maharashtra, India
On-site
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us. Your Role Generate or convert doctors for our product portfolio. Secondary sales – Ensuring to achieve secondary sales targets through prescription generation by each of his BE. Good at relationship with KOLs (Top Physicians, Endocrinologists & Cardiologists) Day to day sales reporting Effective query handling and customer queries. Ensuring 100% Implementation of Company’s strategies Pharmacovigilance (Adverse Event Reporting) – To collect adverse drugs reaction (ADR) incidences including lack of efficacy related to medicinal products up to the maximum possible level of completeness and forward to local Patient Safety team immediately within 24 hours of ADR awareness. The additional information can be submitted as soon as possible Who You Are Any graduate Freshers or minimum of 1-2 years of experience in any pharma company Should have strong product knowledge & communication skills What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team! Show more Show less
Posted 1 week ago
2.0 - 5.0 years
1 - 3 Lacs
Daund, Pune
Work from Office
We are looking for a highly skilled and experienced Branch Receivable Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-5 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 strategies to improve cash flow and reduce outstanding amounts. Collaborate with internal teams to resolve customer complaints and disputes related to receivables. Analyze financial data to identify trends and areas for improvement in the bank's receivables. 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. 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 Microsoft Office and other relevant software applications. Strong analytical and decision-making skills with attention to detail. Experience working with small finance banks or similar institutions is preferred.
Posted 1 week ago
18.0 years
0 Lacs
Kolkata, West Bengal, India
On-site
Project Role: Dir, Service Operations Work Experience: 18+ Years. Work Mode: Kolkata -Hybrid Must Have Skills: Over 18 years of experience in Pharmacovigilance (PV) and strong leadership skills. Job Overview: Provide leadership for Lifecycle Safety, Service Operations (SO), developing cross-functional integrated delivery plans for safety operations throughout all stages of the Lifecycle Safety opportunity chain. Provide leadership for a combination of designated Lifecycle safety operations service lines and direction for specified accounts. Participate actively in local and global initiatives, as needed. Provide line management for assigned staff who are deployed in Service Operations. Primary point of contact for assigned customers or account Essential Functions: Accountable to monitor and track project financials/ budget to ensure agreed margins are maintained. Independently engage assigned customers on escalation, scope expansion and look for additional business opportunities. Lead a high quality and efficient Service Operations team. Develop and review the team reporting structure for IQVIA while adhering to governing standard operating procedures (SOPs), work instructions and applicable regulatory guidelines and regulations. Accountable to meet all project specific SLA and KPI’s Direct and support operational decisions in collaboration with senior management. Ensures financial project performance through oversight of key performance metrics. (revenue, direct costs, time-sheet costs, utilization, and realization). Act as mentor and coach to less experienced managers, as appropriate. Lead and support ongoing overarching operational, strategic, and tactical initiatives as assigned/ agreed, ensuring timely and complete delivery. Direct project resource assignments including staff hiring, and training in collaborations with senior management. Direct and/or participate in cross-functional teams and other process improvement initiatives. Lead and anticipate actively in local and global initiatives, as needed. Support in designing functional strategy! Demonstrate and cascade the organizational vision and mission, core values. Ability to independently participate in Request for proposal (RFP) and bid defense. Ability to represent IQVIA in various industry forums and conference as required. Qualifications: Bachelor's Degree Scientific or healthcare discipline or allied life sciences Bachelor’s degree in health science or related area, and 18 years’ experience in Contract Research Organization or Pharmaceutical company or life science services company, including 10 years of experience in managing a workforce of up to 400+ employees, operating with senior/executive management teams or equivalent combination of education, training and experience. Ability to clearly articulate to large group and build consensus. Ability to address large audience during townhalls and other external forums. Excellent interpersonal skills, effective communication. Engagement with global delivery hubs. In-depth knowledge of Safety service lines. willingness to increase knowledge across Safety service lines and develop new skills. Proven Staff management skills, strong leadership, motivational and influencing skills. Ability to work on multiple projects and manage competing priorities. Effective mentoring and developed coaching skills. Excellent presentation, report writing skills and customer focus skills. Ability to achieve results through communication and facilitation in a matrix service delivery environment with shared accountabilities. Sound judgment, decision-making and problem-solving skills. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Ability to support in drafting SOP, Operation, Technical Project documents. Ability to understand and analyze performance Metrix and numbers to support operations. End to End Project management exposure. Excellent team leadership and customer services skills. strategic customer focus. Strategic understanding of business processes across opportunity chain and all phases of product lifecycle. Strong analytical, judgment and decision-making skills. Strong innovation/solution skills. Strong communication (written and verbal) and presentation skills. Strong problem-solving, influencing, negotiation, conflict management and collaboration skills. Highly effective time management and delegation skills, ability to manage multiple competing priorities, meet multiple demanding timelines and work creatively in fast-paced environment. Strong ability to deliver results to the appropriate productivity, budgetary and quality metrics. Demonstrated flexibility, initiative, proactivity, ownership, and accountability. In depth knowledge of and ability to apply GCP/ICH/Good Pharmacovigilance Practice and applicable regulatory guidelines. Strong ability to establish and maintain effective working relationships with coworkers, managers, and customers. - Extensive use of keyboard requiring repetitive motion of fingers. Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Regular sitting for extended periods of time. May require occasional travel. Flexibility to operate in shifts. Flexibility to support in global time zones as required. Show more Show less
Posted 1 week ago
2.0 years
6 - 9 Lacs
Hyderābād
On-site
About the job Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: Write and/or edit under guidance high-quality safety documents, medical section of Periodic Benefit-Risk Evaluation Report, medical sections of Addendum to clinical overview, Disease and Product ID Cards, product alerts and trial transparency documents. Delivery of high-quality medical documents in time and in compliance with internal and external standards and guidelines. Essential job duties and responsibilities: 1) Participate with support in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 2) Develops and maintains TA expertise. 3) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs teams based on the documents assigned. People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise. Performance: Provide deliverables (PBRER, ACO, Product and Disease ID Cards, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT ) as per agreed timelines and quality. Process: 1) Author, review, and act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis. 3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. 6) Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts. 7) Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. 8) Remain abreast of Sanofi Policy or Quality Documents evolution. Stakeholders: 1) Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Legal/Regulatory/corporate affairs departments to prepare relevant & customized deliverables. About you Experience : >2 years of experience in regulatory writing for the pharmaceuticals/healthcare industry Soft skills : Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment. Technical skills : As applicable (including but not limited to time, and risk management skills, Excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-ver sed with computer applications ) Education : Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters or bachelor’s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD) Languages : Excellent English language knowledge (to read, write and speak) null
Posted 1 week ago
2.0 - 7.0 years
1 - 5 Lacs
Hubli, Thrissur
Work from Office
We are looking for a skilled Branch Receivable Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 5-10 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the branch's receivable portfolio, ensuring timely payments and minimizing bad debts. Develop and implement strategies to improve cash flow and reduce receivables. 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 related to receivables. Lead and motivate a team of professionals to achieve business objectives. Job Requirements Strong knowledge of accounting principles, financial regulations, and banking practices. Excellent communication, leadership, and problem-solving skills. Ability to work in a fast-paced environment and meet deadlines. Proficiency in financial software and systems. Strong analytical and decision-making skills. Experience in managing and motivating a team of professionals.
Posted 1 week ago
2.0 years
0 Lacs
Hyderābād
On-site
About the job Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: Write and/or edit under guidance high-quality safety documents, medical section of Periodic Benefit-Risk Evaluation Report, medical sections of Addendum to clinical overview, Disease and Product ID Cards, product alerts and trial transparency documents. Delivery of high-quality medical documents in time and in compliance with internal and external standards and guidelines. Essential job duties and responsibilities: 1) Participate with support in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 2) Develops and maintains TA expertise. 3) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs teams based on the documents assigned. People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise. Performance: Provide deliverables (PBRER, ACO, Product and Disease ID Cards, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT ) as per agreed timelines and quality. Process: 1) Author, review, and act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis. 3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. 6) Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts. 7) Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. 8) Remain abreast of Sanofi Policy or Quality Documents evolution. Stakeholders: 1) Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Legal/Regulatory/corporate affairs departments to prepare relevant & customized deliverables. About you Experience : >2 years of experience in regulatory writing for the pharmaceuticals/healthcare industry Soft skills : Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment. Technical skills : As applicable (including but not limited to time, and risk management skills, Excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-ver sed with computer applications ) Education : Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters or bachelor’s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD) Languages : Excellent English language knowledge (to read, write and speak) null
Posted 1 week ago
5.0 years
5 - 10 Lacs
Bengaluru
On-site
Country/Region: IN Requisition ID: 26145 Work Model: Position Type: Salary Range: Location: INDIA - BENGALURU - BIRLASOFT OFFICE Title: Technical Specialist-Data Engg Description: Area(s) of responsibility o Job Title – Denodo Developer o No. of Open Positions - 1 o Experience- 5- 9 years o Location: Bangalore, Noida, Chennai, Mumba, Hyderabad, Pune o Shift Time - CET (12:30 to 9:30 IST) Job Description: We are seeking a highly skilled and experienced Denodo Developer with a strong background in ETL processes and deep knowledge of the Life Sciences domain. The ideal candidate will be responsible for developing data virtualization solutions, integrating complex datasets from multiple sources, and enabling real-time data access for analytics and operational reporting. This role requires close collaboration with data architects, data engineers, and business stakeholders in a regulated environment. Key Proficiency & Responsibilities: Design, develop, and optimize data virtualization solutions using Denodo Platform. Integrate structured and unstructured data sources into Denodo views and services. Develop custom views, VQL scripts, and data services (REST/SOAP). Build and optimize ETL/ELT pipelines to support data ingestion and transformation. Work closely with Life Sciences business teams to translate domain-specific requirements into data solutions. Implement data governance, security, and compliance practices adhering to GxP and FDA regulations. Provide support for data access, lineage, metadata management, and user training. Collaborate with cross-functional teams in an Agile development environment. Optimize workflows for performance and scalability. Develop and maintain data documentation, including workflow descriptions and data dictionaries. Strong knowledge of data preparation, ETL concepts, and data warehousing. Excellent analytical, problem-solving, and communication skills. Proficient in VQL, JDBC, ODBC, and web services integration. Strong expertise in ETL tools (e.g., Informatica, Talend, DataStage, or Azure Data Factory). Deep understanding of Life Sciences domain – clinical trials, regulatory data, pharmacovigilance, or research & development. Preferred Qualifications: B.Tech. or MCA from a recognized University Minimum 5+ years of relevant experience as a Denodo Developer. Strong SQL and database skills (Oracle, SQL Server, PostgreSQL, etc.). Knowledge of data modelling, data warehousing, and virtual data layers. Experience with cloud platforms (AWS, Azure, or GCP) is a plus. Experience working in Agile/Scrum environments. Exposure to cloud platforms such as AWS, Azure, or GCP.
Posted 1 week ago
45.0 years
0 Lacs
Bengaluru
On-site
Job ID R-224667 Date posted 06/05/2025 Job Title: Local Case Intake Advisor - Global Business Services Career Level - C Introduction to role Are you passionate about patient safety and compliance? As a Local Case Intake Advisor, you will manage the intake, processing, and reporting of individual case safety reports (ICSRs) at the local level. You will support specific local Marketing Companies to ensure compliance with AstraZeneca (AZ) and relevant national regulatory requirements, serving as the primary liaison between those Marketing Companies and GBS-PS. This role requires fluency in English and involves working under the guidance of Case Intake Team Managers to deliver routine activities independently, resolve moderate scope problems, and conduct activities consistent with things we value and compliance standards. Accountabilities Support provision of pharmacovigilance activities including local processes, procedures, and systems for collection, reporting, and tracking of Adverse Events (AEs). Review, assess, and process safety data from various sources, distributing reports to internal and external third parties. Identify Product Quality Complaint (PQC) and Product Security complaints, collecting necessary information for AE complaint reporting. Provide prompt support for regulatory authority queries related to the Patient Safety function. Implement Corrective and Preventative Actions in the event of local non-compliance. Ensure reconciliations for the accuracy of pharmacovigilance data transferred and received. Periodically screen regulatory authority databases for adverse events. Perform literature search and related activities for MC product portfolio if required. Undertake manual follow-up where required, disseminating clear and accurate information based on approved call scripts. Maintain filing and archiving practices of patient safety documents. Actively contribute to maintaining Good Pharmacovigilance Practice and being audit and inspection ready. Support external service providers to meet company and local regulatory PV requirements. Assist the local PS team in audits or regulatory authority inspections. Complete all required patient safety trainings and obtain access to relevant systems. Maintain current knowledge of relevant country regulatory authority regulations, global and local procedural documents, marketed status of products, and conditions relating to product safety. Essential Skills/Experience Degree Qualified – Pharmacy/ Medical/ Science Pharmacovigilance knowledge excellence Good Pharmacovigilance Practice Knowledge of health authority regulations Cross-functional collaborative approach Effective and lateral thinking Problem solving Vendor management Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience Influencing and Conflict Resolution skills Medical knowledge in company Therapeutic Areas Project management Successful participation in above-market projects Audit & Inspection experience When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, our work has a direct impact on patients, transforming our ability to develop life-changing medicines. We empower the business to perform at its peak by combining cutting-edge science with leading digital technology platforms and data. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Here you can innovate, take ownership, and explore new solutions in a dynamic environment that encourages lifelong learning. Ready to make a difference? Apply now to join our team! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Local Case Intake Advisor - Global Business Services Posted date Jun. 05, 2025 Contract type Full time Job ID R-224667 APPLY NOW Why choose AstraZeneca India? Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare. The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports. Who do we look for? Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day. Success Profile Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for. 0% Tech innovators Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives. 0% Ownership takers If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level — with unrivalled support when you need it. 0% Challenge seekers Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks. 0% Proactive collaborators Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best. Responsibilities Job ID R-224667 Date posted 06/05/2025 Job Title: Local Case Intake Advisor - Global Business Services Career Level - C Introduction to role Are you passionate about patient safety and compliance? As a Local Case Intake Advisor, you will manage the intake, processing, and reporting of individual case safety reports (ICSRs) at the local level. You will support specific local Marketing Companies to ensure compliance with AstraZeneca (AZ) and relevant national regulatory requirements, serving as the primary liaison between those Marketing Companies and GBS-PS. This role requires fluency in English and involves working under the guidance of Case Intake Team Managers to deliver routine activities independently, resolve moderate scope problems, and conduct activities consistent with things we value and compliance standards. Accountabilities Support provision of pharmacovigilance activities including local processes, procedures, and systems for collection, reporting, and tracking of Adverse Events (AEs). Review, assess, and process safety data from various sources, distributing reports to internal and external third parties. Identify Product Quality Complaint (PQC) and Product Security complaints, collecting necessary information for AE complaint reporting. Provide prompt support for regulatory authority queries related to the Patient Safety function. Implement Corrective and Preventative Actions in the event of local non-compliance. Ensure reconciliations for the accuracy of pharmacovigilance data transferred and received. Periodically screen regulatory authority databases for adverse events. Perform literature search and related activities for MC product portfolio if required. Undertake manual follow-up where required, disseminating clear and accurate information based on approved call scripts. Maintain filing and archiving practices of patient safety documents. Actively contribute to maintaining Good Pharmacovigilance Practice and being audit and inspection ready. Support external service providers to meet company and local regulatory PV requirements. Assist the local PS team in audits or regulatory authority inspections. Complete all required patient safety trainings and obtain access to relevant systems. Maintain current knowledge of relevant country regulatory authority regulations, global and local procedural documents, marketed status of products, and conditions relating to product safety. Essential Skills/Experience Degree Qualified – Pharmacy/ Medical/ Science Pharmacovigilance knowledge excellence Good Pharmacovigilance Practice Knowledge of health authority regulations Cross-functional collaborative approach Effective and lateral thinking Problem solving Vendor management Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience Influencing and Conflict Resolution skills Medical knowledge in company Therapeutic Areas Project management Successful participation in above-market projects Audit & Inspection experience When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, our work has a direct impact on patients, transforming our ability to develop life-changing medicines. We empower the business to perform at its peak by combining cutting-edge science with leading digital technology platforms and data. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Here you can innovate, take ownership, and explore new solutions in a dynamic environment that encourages lifelong learning. Ready to make a difference? Apply now to join our team! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. APPLY NOW Explore the local area Take a look at the map to see what’s nearby. Reasons to Join Thomas Mathisen Sales Representative Oslo, Norway Christine Recchio Sales Representative California, United States Stephanie Ling Sales Representative Petaling Jaya, Malaysia What we offer We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you. Lifelong learning Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still. Autonomy and reward Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing — with performance-based rewards as part of the package. Health and wellbeing An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority. Inclusion and diversity Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.
Posted 1 week ago
0.0 - 1.0 years
0 Lacs
Bengaluru
On-site
Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Physiotheraphy Years of Experience: 0 to 1 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Junior Drug Safety Associate Junior Drug Safety Associate Roles and Responsibilities: •In this role you are required to solve routine problems, largely through precedent and referral to general guidelines • Your primary interaction is within your own team and your direct supervisor • In this role you will be given detailed instructions on all tasks • The decisions that you make impact your own work and are closely supervised • You will be an individual contributor as a part of a team with a predetermined, narrow scope of work • Please note that this role may require you to work in rotational shifts Bachelor of Physiotheraphy
Posted 1 week ago
2.0 - 5.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Summary The primary responsibility of this role is to manage patient oriented program (POP). Responsible to ensure compliance in POP end to end activities as per the applicable process and quality standards. Liaison with the cross functional team for successful execution of POP. About The Role Analyst Patient-Oriented Program Location – Hyderabad Hybrid About The Role: The primary responsibility of this role is to manage patient oriented program (POP). Responsible to ensure compliance in POP end to end activities as per the applicable process and quality standards. Liaison with the cross functional team for successful execution of POP. Key Responsibilities: Administer end to end POP process on behalf of Business Owner (BO) in accordance with Doing Business Ethically (DBE) policy and POP Standard Operating Procedures (SOP). Coordinate with all POP stakeholders (POP Champion/ Procurement/ Legal/ Patient Safety/ Compliance/Quality Assurance) and create POP documents. Responsible for obtaining the necessary approvals for conduct of POP in a timely manner. Responsible for the overall management of the External Service Providers (ESP) compliance check prior to fieldwork initiation. Enter program details in the POPsys database throughout the conduct of the POP. Keep track of all required activities (First Participant First Contact (FPFC)/Last Participant Last Contact (LPLC) dates, Adverse Event Reconciliation (AER), Periodic Reviews, closure, etc.) related to POP conduct and ensure no monitoring gaps before program closure in POPsys. Maintain documentation for all POP related activities in POP repository. Ensure identified quality issues are well documented in quality issue (QI) management tool. Create issue record and perform proper investigation, root cause analysis followed by risk assessment and corrective and preventive actions (CAPA). Ensure proper handover of activities when leaving the role/organization/planned leaves and liaise with POP Champion. Effective management of all projects assigned, and timely escalation of findings related to projects. Seek constant feedback from stakeholders and improve on suggestions put forth. Essential Requirements: Preferrable experience with 2- 5 years’ experience in the pharmaceutical industry within Clinical, Pharmacovigilance (PV), Medical/regulatory Affairs, or relevant experience in pharma compliance or commercial framework. Good understanding of local regulatory requirements and applicable policies surrounding pharmaceutical industry Ability to communicate effectively across different audiences, organizational levels and local and global teams. Desirable Requirements: College/university degree, preferably in security, criminal justice, crisis management, business continuity or other related field. Advanced degree is highly desirable (e.g., Master’s degree or MBA). Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less
Posted 1 week ago
1.0 years
0 Lacs
Bengaluru, Karnataka, India
Remote
Company Information At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials. Company Culture Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives. At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact. Job Duties & Responsibilities Understand and interpret clinical trial study protocols to design and develop calendars. Understand and interpret clinical trial agreements and sponsor budgets to develop site budgets for the protocol. Design and develop case report forms for clinical trial study protocols Develop a familiarity with Advarra’s Clinical Trial Management Software (CTMS) and Electronic Data Capture (EDC) software to utilize related functionalities in the design and development of calendars, budgets, financials and case report forms. Work closely with reporting manager to complete daily/ weekly calendars, budgets, financials and/or case report forms design to meet with pre-determined quality criteria. Understand and utilize internal case management software and other reporting software to ensure that daily/weekly work assignments are appropriately tracked and completed. Actively participate in team meetings and contribute meaningfully to discussions related to specific customer cases and/or protocols. Location This role is open to candidates working remotely or hybrid in Bengaluru, India. Basic Qualifications 1+ Years of relevant experience Knowledge of clinical research methodology, industry regulations and Good Clinical Practice guidelines related to human research. Expected to work independently, as well as in a team environment. Good organizational and administrative abilities Familiarity with MS Office and various business software Preferred Qualifications Clinical trial coordinator at site Clinical data management Pharmacovigilance Records management Physical And Mental Requirements Sit or stand for extended periods of time at stationary workstation Regularly carry, raise, and lower objects of up to 10 Lbs. Learn and comprehend basic instructions Focus and attention to tasks and responsibilities Verbal communication; listening and understanding, responding, and speaking Advarra is an equal opportunity employer that is committed to diversity, equity and inclusion and providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information or any other status or characteristic protected by central, state, or local law. Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment. Show more Show less
Posted 1 week ago
8.0 years
15 - 19 Lacs
Hyderabad
Work from Office
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Skills: Min 5 yrs of experience in Data Acquisition domain. Expertise in Handling Non-CRF activities, able to work autonomously on the non-CRF data strategy. In-depth understanding of Data Management conventions, data standards, Processes and Drug development Process. Experience with Study convention including non-CRF collection data standards, Processes, Knowledge sharing and best practices on assigned studies. Influence Study Team to adhere non-CRF guidance, processes and negotiate contingency plans to mitigate delays of deliverables. Task: Lead collection of non-CRF data during Study Setup, Conduct and Closeout activities IXRS and Complex Data Models. Effectively communicate non-CRF data collection deliverable, Status of work and Data issues to the assigned study team and SME’s. Collaborate with multiple non-CRf vendors or data providers to setup Data Transfer Agreement to ensure timely and quality delivery.
Posted 1 week ago
8.0 - 10.0 years
0 Lacs
Gurgaon, Haryana, India
On-site
Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Clinical Data Programming Date: May 14, 2025 Location: Gurgaon - R&D Company: Sun Pharmaceutical Industries Ltd JOB DESCRIPTION Form074230-V1.0, ED:29-Mar-2024 Job Role Name Clinical Database Programmer (CDP) Department Name Global Clinical Data Management (GCDM) Job Purpose The incumbent manages Clinical Data Programming to ensure timely creation, validation, testing, implementation and maintenance of databases required across all assigned projects. Analyzes study protocol and project requirement(s), identifies data quality rules, and design data entry interfaces in accordance to the study Protocol, DMP, SOP and all applicable regulatory requirements and standards. Key Roles And Responsibilities Deploy complete, accurate and efficient clinical study database(s) for the purpose of Data Management and Data processing. Support and ensure the preparation, transfer and integration of clinical data from internal and external sources into the clinical study database. Provide clinical study data in various formats and applications to all critical project stake holders, as required. Ensure high quality deliverables, good cooperation with internal and external project stake holders and active participation in project teams to develop and maintain programs to meet project standards. Responsible for data exchange with external project stake holders, for example, third party vendors (Labs, ECG, etc.) and Safety / Independent Data Monitoring Committees, as required. Provide ongoing day to day end-user support to the project team(s) to ensure all systems and programs are executing correct and efficiently. Setup and support of data review and reporting tools required by DM stakeholders SAS programmers, Clinical, Medical, Pharmacovigilance and Regulatory Affairs and where required by the Study Management Team. Provide technical expertise and programming support for projects and data management staff. Communicate project status and key project issues to DM Management. Assist in developing new Data Systems programming procedures and processes. Keeps current with technological advances and coordinates activities with Global Training and Information Technology Team in an effort to maximize their potential use in managing data. Provide mentoring and training of other while assist in work delegation. Supports, maintains and utilizes standardization of CRF and eCRF modules, data quality rules, data structures, data libraries, code lists, and dictionaries in conjunction with input from other functional areas and project teams and in accordance with CDISC standards. May take part in evaluating external vendors and technologies as to their ability to perform in accordance to project goals, procedures, and quality standards prior to project scope finalization. Identifies areas of process improvement that may be provided by standardization and/or technology to increase efficiency, quality and timeliness of data management processes and deliverables. Qualification, Skill And Competencies Requirements Preferably a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline. Minimum 8-10 years of clinical data programming experience including working knowledge using clinical data programming tools and applications. Experience of leading clinical programming effort across global clinical studies is preferred. Job Location Gurugram, HR Reporting To Clinical Database Programming Lead (CDPL) Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less
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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.
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