We are Hiring For Leading ITES Company for the position of PV Aggregate Reporting Role Job Descriptions To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 54 b) For Position in Pune Search : Job Code # 55

Are you a seasoned professional in Pharmacovigilance Quality AssuranceWe are looking for a Pharmacovigilance QA Head to lead and manage our PV QA function, ensuring excellence in compliance and quality standards. Key Responsibilities: Team Management & Oversight of following: 1. Independent quality review of ICSRs: Conduct independent quality reviews for Individual Case Safety Reports (ICSRs) with a strong understanding of the ICSR process (Must have) Oversee the quality review of aggregate reports (Preferred). 2. Quality Management System: Develop and maintain life cycle of Standard Operating Procedures (SOPs). Manage the change control system. Address process non-conformance, including investigations, root cause analyses (RCA), corrective actions, monitoring effectiveness, and trend analysis. Process improvements and implement best practices for PV QA methodologies. 3. Training Management: Maintain and update training matrices. Identify training needs and ensure the delivery of effective training programs. 4. Audit Readiness: Prepare for audits by facilitating data requests and communication for internal and health authority inspections. Respond to audit findings and implement corrective and preventive actions accordingly. 5. Compliance Monitoring & Risk Mitigation of multiple projects with defined frequency 6. Conduct Quality review meetings Experience: - 10-15 years in Pharmacovigilance Quality Assurance (PV-QA). - Preferable experience in Pharmacovigilance operations and PV-QA - Proven track record of Previous People Management. - Experience in both pharmaceutical companies and service-based organizations. Education: - Bachelor s or Master s degree in Pharmacy or a related field. Skills: - Excellent verbal and written communication. - Strong client handling abilities. - Proficient in presentation skills to effectively convey information and engage stakeholders. Why Join Us This is a unique opportunity to lead a critical function in ensuring the safety and compliance of pharmacovigilance processes. If you re passionate about quality assurance and have a proven track record of leading successful teams,.

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Medical Information Specialist (MIS) position is part of the ProPharma Medical Information Contact Center and follows all corresponding regulations, industry standards, and client/internal policies regarding medical information and the collection and documentation of adverse events, special situation events, and product complaints. Essential Functions Include:Medical Information service delivery Responds to unsolicited consumer, health care professional and other external customer requests for medical and safety information received via telephone, website/e-mail, letter, fax, and scientific meetings on behalf of ProPharma’ s pharmaceutical clients. Provides labeled and unlabeled medical/safety information responses in accordance with regulatory requirements, industry standards and client and ProPharma internal policies and practices. Accurately identifies, documents and reports adverse events, pregnancy reports, special situation events and product complaints in a clear and concise manner per government regulations, ProPharma Standard Operating Procedures (SOPs) and client Working Practices (WPs). Ensures tasks are completed within the deadlines documented in the agreed ProPharma SOPs and WPs. Formulates and provides accurate responses utilizing approved labeling and company standard responses, published literature and other data. Assists with writing custom medical information responses utilizing this data. Logging all enquiries handled in an accurate, comprehensive, and timely fashion into Inquiry Handling Systems. Quality Assurance Maintains quality in all areas of the job, including performing quality checks on Adverse Events, Product Quality Complaints, correspondence, and enquiries logged into the Inquiry Handling Systems General Provides after-hours coverage on a rotated basis subject to business requirements. Adheres to company and country-specific privacy policies, ensuring any confidential information or personal data related to ProPharma and its clients is managed in accordance with Data Privacy regulations described in ProPharma SOPs and the Confidentiality Statement within the Contract of Employment. Complies with the Company’s health and safety policies. Other activities as assigned as delegated by the Manager. Qualified Candidates Must Have Life science degree OR Nursing degree (RN/BS/BA/MS) OR Pharmacy degree Excellent verbal and written communication skills, including proofreading, professional telephone etiquette and empathetic customer service skills. Ability to write in a fluent and grammatically correct manner in the target language for the role English language proficiency. Japan-based roles only: TOEIC 800= Working knowledge of medical terminology, pathophysiology, pharmacology, regulations and industry standards. Strong cognitive abilities, including verbal reasoning, critical thinking and analytical ability. Ability to multitask with attention to detail within restrictive timeframes, including sound planning, prioritizing and organizational skills. Proactive with demonstrative ability to independently identify problems and suggest effective solutions. Ability to learn, take instruction and apply to daily operations/tasks. Receptive to constructive feedback and able to take responsibility for work allocated. Self-motivating. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload projects. Effectively work independently and as part of a team. Highly proficient in computer applications, including Microsoft Office software platforms and Adobe Acrobat, and experience using a document management system. Aptitude to learn other computer systems including inquiry handling database. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Job Title: Business Development Manager – Pharmacovigilance Department: Pharmacovigilance Location: AhmedabadEmployment Type: Full-time Job Summary: The Business Development Manager will be responsible for setting up the pharmacovigilance department, Identifying business opportunities and driving revenue growth. This role requires a strategic thinker with expertise in pharmacovigilance services, client relationship management and market expansion. Key Responsibility:PV Department Setup: Designed roadmap, ensured global regulatory compliance and defined service offerings.Business Development: Identified opportunities, built partnerships and expanded client base across pharma & biotech.Client & Partner Management: Handled contracts, maintained strong client relations and represented the company at key industry events.Market & Competitive Insight: Monitored trends, regulations and competitor strategies to inform business planning.Proposal & Bid Handling: Responded to RFPs/RFIs and led bid defenses to secure new projects.Revenue Growth Focus: Achieved business targets and optimised sales strategies for sustained growth. Qualifications & Skills:MBA or a degree in Life Sciences, Pharmacy or related fields. 5+ years of experience in business development within pharmacovigilance or clinical research. Strong understanding of global pharmacovigilance regulations. Excellent communication, negotiation and networking skills. Ability to work independently and drive strategic initiatives.

Job Description Summary :- Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) report, Risk Management Plan (RMP), Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs) as well as preparing document of comparison between local and global labeling document (if applicable) and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and signal detection and management (where applicable). Generating Line Listings, creating drug lists/drug folders, performing regulatory submissions, tests electronic submissions gateways, and tracking compliance monitoring of submissions in accordance with client/international conventions Responsible for preparing the narratives associated with the client’s/sponsor’s products from clinical trials for Clinical Study Reports (CSRs) or in order to support any health authority requests in accordance with regulatory and client’s/sponsor’s requirements Scheduling and Attending meetings/ Drafting meeting agenda and minutes/Tracking action items. Job Description:- Preparing/updating/merging RMPs/Company Core-RMPs (CC-RMPs), preparing a health authority response document along with RMS update in accordance with client requirements/conventions and SOPs. Managing scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) report, Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs), comparison document between local and global labeling document (if applicable)and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and conventions and SOPs Conducting critical appraisal and systematic review of literature with a focus on background epidemiology, specifically information on the incidence, prevalence and risk factor in patient populations, for inclusion in drug Safety Reports and RMPs Providing input and developing literature search strategies for the epidemiology section of safety reports Applying epidemiological methods and calculations to data available in literature to support the background rates of the issues under evaluation for the safety reports Generating Line Listings for submissions/ to identifying discrepancies and ensuring resolution of the discrepancies Revising document drafts based on the review comments from team members to ensure inclusion of all relevant input. Ensuring that all work is complete and of high quality prior to team or client distribution. Confirm data consistency and integrity across the document. Performing aggregate report compliance activities including quality review to check the data/facts and internal consistency across various type of aggregate reports including but not limited to PBRERs, Ad hocs, HHEs, LJDs, tables, RMP, Pharmacovigilance System Master File (PSMF) document (as applicable). Distributing of final reports to the stakeholders including partners, affiliates and submission to health authorities, according to the agreed timelines, distribution lists and email templates (as required). Scheduling and Attending meetings/ Drafting meeting agenda and minutes/Tracking action items. #LI-REMOTE

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 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? Drug Safety associate 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 expected interactions are within your own team and direct supervisor • You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments • The decisions that you make would impact your own work • You will be an individual contributor as a part of a team, with a predetermined, focused scope of work • Please note that this role may require you to work in rotational shifts Bachelor of Pharmacy,Master of Pharmacy

Site Name: Bengaluru Luxor North Tower Posted Date: May 12 2025 Years of Experience: 9 to 12 years Skill Set / Exposure: PV background, DSUR, PBRER, Addendum to CO, PADER/PAER and Risk Management Plans. Job Description: The Principal Medical Writer is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of safety documents (e.g., aggregate reports and Risk Management Plans [RMPs]) and interpretation of safety data. They must demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues. This role requires extensive safety document expertise and will support continuous improvement and the implementation of best practices and adoption of new tools and technology. Key Responsibilities: Independently lead preparation of complex clinical and post-market safety documents, including but not limited to Development Safety Update Reports (DSURs), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs), Addendums to Clinical Overviews (ACOs), US Periodic Adverse Drug Experience Reports/Periodic Adverse Experience Reports (PADERs/PAERs), RMPs and responses to regulatory authority questions. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions. Lead cross-functional teams in document preparation including but not limited to development of content strategy, coordination of content contributions, organization of review schedules, and project timelines. Work in a matrix team to ensure delivery of high-quality, fit-for-purpose documents that reflect accurate interpretation of associated safety, clinical, and statistical data, and are in line with GSK standards and global, regional, and/or local regulatory requirements. Understand the interdependencies of various contributing functions (e.g., safety, regulatory, clinical, epidemiology, statistics, and programming). Anticipate and evaluate complex situations and problems, resolving them by leveraging scientific and operational knowledge in collaboration with stakeholders. Assess trends and patterns in text and statistical data and effectively organize content and messages in safety documents. Use approaches to expedite document preparation, including authoring and reviewing tools, as well as other automation/technology platforms. Serve as a mentor for less experienced writers. Develop and deliver training on medical writing topics. Lead initiatives to improve medical writing processes. Contribute to vendor oversight as needed. Education Requirements: Master’s degree or equivalent in a scientific discipline. A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine, which involves patient exposure in a hospital-based environment, would be an advantage. Job Related Experience: Minimum of 7 years of advanced safety writing experience in the pharmaceutical domain including summarization and interpretation of complex data and preparation of complex documents. In depth working knowledge of: Relevant regulatory guidance (e.g., ICH, GVP, FDA, EMA) pertaining to clinical trial conduct, pharmacovigilance, and document-specific requirements. Core cross-functional clinical research roles and procedures, and how they relate to document strategy and operational preparation. Experience in multiple therapeutic areas to have confidence to dive into these areas without lead time. Advanced understanding of and ability to apply the statistical, regulatory, and medical communication concepts needed to independently write complex safety documents. Other Job-Related Skills: Advanced safety writing skills with expertise in most safety document types. Highly collaborative, capable of leading cross‐functional team members, negotiating solutions, and advising them on document structure and content as needed. Skilled in navigating multicultural settings, ensuring effective collaboration with diverse customers and clients, such as health authorities and patients, while adeptly collaborating with remote teams. Able to independently lead multiple projects simultaneously and deliver multiple high-quality documents on schedule. Advanced computer skills and general computer literacy. Excellent English language proficiency, both verbal and written. Inclusion at GSK: As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs. 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.

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing Years of Experience: 1 to 3 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? •Ability to meet deadlines •Ability to work well in a team •Adaptable and flexible Roles and Responsibilities: •In this role you are required to solve routine problems, largely through precedent and referral to general guidelines • Your expected interactions are within your own team and direct supervisor • You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments • The decisions that you make would impact your own work • You will be an individual contributor as a part of a team, with a predetermined, focused scope of work • Please note that this role may require you to work in rotational shifts Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing Years of Experience: 1 to 3 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? •Adaptable and flexible •Agility for quick learning •Ability to work well in a team Roles and Responsibilities: •In this role you are required to solve routine problems, largely through precedent and referral to general guidelines • Your expected interactions are within your own team and direct supervisor • You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments • The decisions that you make would impact your own work • You will be an individual contributor as a part of a team, with a predetermined, focused scope of work • Please note that this role may require you to work in rotational shifts Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing Years of Experience: 1 to 3 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? •Adaptable and flexible •Agility for quick learning •Ability to work well in a team Roles and Responsibilities: •In this role you are required to solve routine problems, largely through precedent and referral to general guidelines • Your expected interactions are within your own team and direct supervisor • You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments • The decisions that you make would impact your own work • You will be an individual contributor as a part of a team, with a predetermined, focused scope of work • Please note that this role may require you to work in rotational shifts Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing

Prepares medications by reviewing and interpreting physician orders; detecting therapeutic incompatibilities. work flow; verifying their preparation and labeling of pharmaceuticals; verifying order entries, charges, and inspections.

Develop and maintain interactions with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. MSLs will use various channels for interactions (1:1, group presentation; remote, etc). Develop and execute a medical interaction plan with Key accounts (Army, Railways, CGHS etc.) as per the needs of the stakeholders and the overall medical strategy. Effectively present information to HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with Thought Leaders to understand their needs and expertise. Continuously update their own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers. Collect and provide meaningful medical insights back to the medical and commercial organizations to be actioned in support of the strategy development. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures. Contribute to the Country Medical Plan Develop territory Field Medical plan and TL Interaction plans based on therapeutic area objectives and TLs needs. Execute certain medical plan activities as assigned. Adopt institution/account planning approach and contribute to cross-functional institution/account plans. Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan. Provide Medical Support As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Market Access). Provide scientific support at promotional meetings by presenting unbiased scientific and clinical data, by evaluating speakers and by giving support to BMS-contracted speakers. Support Clinical Trial Activities Support Interventional and Non-Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with local medical management and as defined by the study scope document. Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with local medical management. Actively support CRO sponsored studies as agreed with local medical management and as defined by the study scope document. Support HCPs in the ISR submission process as agreed with local medical management. Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events. Contribute towards the Patient advocacy programs Support the implementation of the patient education programs in collaboration with the patient advocacy groups. Support the creation of patient education materials. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures Qualifications MBBS, MD, BDS, MDS 1-2 years of Field Medical experience in medical affairs is preferred. Candidates with experience in the Oncology and Haematology therapy area will be preferred. Languages Excellent English language skills - spoken and written. Experience And Knowledge Working in a scientific and/or clinical research environment Ability to work independently and act as a team player. Have an innovative mindset and approach. Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients. Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals Ability to quickly and comprehensively learn about new subject areas and environments. Disease area knowledge and an understanding of scientific publications Knowledge of clinical trial design and process Knowledge of the national healthcare and access environment Knowledge of HEOR core concepts (Health economic and outcome research) is a plus.

Fresher Hiring 2023 - 2025 Passouts only - All India Qualification - B.Pharm, M.Pharm, B.SC, M.SC, Life Sciences Graduates & Post Graduates Medical - BDS, BHMS, BAMS, MBBS Role & responsibilities Perform data reconciliation between different data sources and study documents to ensure data integrity and consistency across datasets. Generate data queries to address discrepancies, inconsistencies, and missing data identified during data review, ensuring timely resolution and documentation of data queries Communicate data queries to investigative sites, data managers, and study personnel, following up on query responses and resolving discrepancies in collaboration with relevant stakeholders Identify deviations from protocol-specified procedures, eligibility criteria, and data collection guidelines, escalating issues to appropriate personnel for resolution Perform quality checks and data validation procedures to ensure accuracy, consistency, and reliability of clinical trial data, adhering to data management standards and industry best practices Assist in the development and implementation of data validation plans, data review guidelines, and quality control procedures to maintain high standards of data quality and integrity. Assist in a variety of specialties including but not limited to primary care, orthopedics, rheumatology, etc. Updates patient history, physical exam, and other pertinent health information in the document as required. Complies with Compliance standards of the Organization as laid by HIPAA. Performs other duties and tasks to improve provider productivity and workflow as assigned by supervisors. Assist documenting the patients, electronic health record (EHR). Fresher Hiring - Pharma / Life Sciences / Medical Qualification - B.Pharm, M.Pharm, B.SC, M.SC, Life Sciences Graduates & Post Graduates Medical - BDS, BHMS, BAMS, MBBS Location - All India - Delhi, Mumbai, Pune, Bangalore, Kochi, Chennai, Hyderabad, Ahmedabad, Bhopal, Indore, Kolkata, Chandigarh

Job title: Pharmacovigilance Periodic Reporting Oversight Specialist Location: Hyderabad 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: to bring health in people’s hands by making self-care as simple as it should be for over half a billion consumers worldwide. 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 four 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 to bring health in your hands at www.opella.com. Main Responsibilities The PRM Oversight Team are the specialists on the regulatory requirements (CH GVP, ICH, CFR etc.) and process owners for the authoring Global periodic safety reports (PSRs) coordinated by Opella Global Pharmacovigilance (Opella PV).The PRM Oversight Team is the Opella GPV representative in inspections and audits responsible for explaining PSR authoring processes owned by the PRE Team.The PRM Oversight is responsible for providing responses to Health Authority Assessment reports regarding PSR content in collaboration with the Global Safety Officer (GSO), Global Safety Sciences and Qualified Person for Pharmacovigilance (QPPV) when applicable.Through content authoring and project management activities, the PRM Oversight ensures Global continuity of the safety messaging within PSRs across applicable regulatory submission documents (RMP, DSUR, RSI) to support final approval and signature by the GSO/QPPV.The PRM Oversight team assures PSR submission compliance to global regulatory authorities by fostering productive and supportive relationships with internal participants (GSO, QPPV, Risk Management Office, Global Safety Sciences, System Support Unit) and PSR contributors external to Opella GPV (Global Business Units, Medical functions, Global Regulatory Affairs, Biostatistics and Programming, Clinical Science Operations).The PRM Oversight drives continuous improvement for periodic reporting processes and quality documents.The PRM Oversight team oversees vendors participating in periodic reporting activities, provides clear guidance on process expectations and productive feedback to ensure adherence to quality document requirements.The PRM Oversight is the centralized Opella PV expert on the regulatory framework for Global PSRs.Provides Global PSR format training and support to contributors.Participates in inspections and audits to communicate PSR processes and expectations as defined in quality documents.The PRM Oversight team implements process and quality document changes when regulatory requirements change, or process improvements are identified.The PRM Oversight authors and coordinates the pharmacovigilance content, including signal detection analyses, for Global PSRs with respect to the cumulative product experience.The PRM Oversight is the expert in systematically assessing relevant product content for inclusion in PSRs from available regulatory and product monitoring documentation.Leads and manages the cross-functional coordination of PSRs and Global PV contribution to PSRs to ensure regulatory submission compliance.Leads the authoring of Global PSRs according to an existing outsourcing strategy.The PRM Oversight is expected to foster productive relationships with cross-functional teams that appropriately represent the PRE team as a whole.Accountable for complying to PRM Oversight timelines, accurate tracking of contributions from contributors and communicating report quality expectations.Responsible for management escalation regarding non-compliance to PSRs timelines, quality expectations, and proceduresAccountable for the maintenance of the appropriate documentation utilized during Global PSR authoring.Participate in Health Authority assessment report responses, inspections, and internal and partner audits regarding the Global PSR processes.Responsible for responding to health authority and partner questions regarding the Global PSR content and processes.Responsible for onboarding, training, and supporting outsourcing vendors to ensure compliance to internal and regulatory process and quality requirements.Provide ongoing productive support and feedback to the vendor to ensure adherence to Opella policies and quality expectationsRequired to track and report recurrent vendor quality issues to management.Responsible for participating in or managing vendor meetings.Provide quality and compliance oversight of vendor activities for Opella Periodic Reports (PBRER/DSUR/SASR/etc.) and continuous improvement of processes:Oversight for PSR-related activities performed by vendorData collection of PBRER KPI’s and documentation of these in Quality trackerQuality findings from QC checklists uploaded in Veeva vault are checked and entered in Quality trackerTimeline guides for PBRER checked and delays (if any, along with the reason for delay) are documented in Quality trackerProvide assessment of critical findings in the Quality trackerManage and support quality and compliance trending/metrics/KPIs/ Scorecard(s) of periodic reports (i.e. HA, PBRER, DSUR, SDEA)Kick Off meeting management and conductContinuous Improvement of PSR processesNew QDs & training plan/documentation for Opella PV Periodic Reports team – maintain quality documents, updated with the new regulations and Opella processes.Organizational ReadinessAccountable for complying to timeline expectations and for the accurate and reliable tracking of quality and compliance metrics for Global PSRsSupport/provide the root cause analyses associated with quality and compliance deviationsManage and provide support for Local PBRER/Business partner requestsParticipate and provide contributions for the Periodic Partner Compliance Review Meeting (PPCRM Survey), relating to any deviation matters identified in respective activities involving Opella Business Partners Experience About you Overall 5-6 years of experience Pharmacovigilance Aggregate Safety Reports, Medical Writing, and Periodic safety reportsExperience in PBRER planning and authoringProactive and strong project management experience including multi-tasking of deliverables with competing timelinesFlexibility to adapt to changing priorities and delaysFluency in ICH and GVP guidelines regarding periodic safety report contentKnowledgeable in PSR relevant regulations across major markets including but not limited to EU, US, China, Brazil, Japan, Canada etc.,Comfortable leading cross-functional meetings in EnglishStrong interpersonal skills and the ability to collaborate productively in an international and multi-cultural environmentProficiency in Microsoft applications (Word, Power Point, Excel)Fluent spoken and written EnglishIncumbent should have experience in Process Improvement practices Soft Skills Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions.Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities.Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.Excellent team-work and interpersonal skillsAbility to work in cross-functional teamsExcellent oral and written communication skillsStrong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Technical Skills Regulatory Standards, Good Pharmacovigilance Practices (GxP), Safety Reporting RequirementsDatabase Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data.Software Testing/Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgradesReport Writing: Ability to write clear, concise, and accurate reports, including regulatory reports, internal analyses, and safety assessments. This includes the ability to translate complex data into understandable narratives.Business Intelligence Tools: Experience with tools like Power BI, or Spotfire to create visual reports and dashboards for stakeholders.Leadership, Teamwork and Management skillsGood interpersonal skillsExcellent project management skillsStrong decision-making skillsStrong knowledge of worldwide pre and post marketing safety reporting regulations and requirements and ICH Education Healthcare Professional / Life science Graduate or Equivalent with a 5-year minimum experience of Pharmacovigilance Safety Reports relevant experience Languages: Fluent in English (verbal and written) 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

In this Role you will be Responsible for The coder reads the documentation to understand the patient's diagnoses assigned. Transforming of healthcare diagnosis, procedures, medical services, and equipment into universal medical alphanumeric codes Creating uniform vocabulary for describing the causes of injury, illness & death is the role of medical coders. Medical coding allows for Uniform documentation between medical facilities. The main task of a medical coders is to review clinical statements and assign standard Codes Requirements of the role include 1 Year of experience in any Healthcare BPO - University degree or equivalent that required 3+ years of formal studies in Life science/BPT/Pharm/Nursing Good knowledge in human Anatomy/Physiology Experience using a computer with Windows PC applications that required you to use a keyboard, navigate screens, and learn new software tools. Ability to work scheduled shifts from Monday-Friday 7:30 AM to 5:30 PM IST and the shift timings can be changed as per client requirements. Flexibility to accommodate overtime and work on weekend basis business requirements. Need to return to office when NTT Data provides communication related to that.During training you will be asked to work from office * Career Arch Job code Overview and General duties and tasks For Internal Reference Only

In this Role you will be Responsible for Should have experience in Radiology coding The coder reads the documentation to understand the patient's diagnoses assigned. Transforming of healthcare diagnosis, procedures, medical services, and equipment into universal medical alphanumeric codes Creating uniform vocabulary for describing the causes of injury, illness & death is the role of medical coders. Medical coding allows for Uniform documentation between medical facilities. The main task of a medical coders is to review clinical statements and assign standard Codes Requirements of the role include 1 Year of experience in any Healthcare BPO - University degree or equivalent that required 3+ years of formal studies in Life science/BPT/Pharm/Nursing Good knowledge in human Anatomy/Physiology 1+ year(s) of experience using a computer with Windows PC applications that required you to use a keyboard, navigate screens, and learn new software tools. Ability to work scheduled shifts from Monday-Friday 7:30 AM to 5:30 PM IST and the shift timings can be changed as per client requirements. Flexibility to accommodate overtime and work on weekend basis business requirements. It is Mandatory to return to office based on client or business requirement.

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!

Works with a team of Medical regulatory writers with different levels of expertise, Develops medical expertise within Medical regulatory writing (on contents, methods, and processes). Ensures compliance with regulatory requirements from various regions (FDA, EU others) for activities supported. Coordinates and supports medical activities related to the maintenance of the marketing authorizations of Established and Generic products, in different therapeutic areas. Works in close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and vendors Essential Job duties and responsibilities: Responsible to provide a medical assessment with relevant and updated clinical evidence and monitoring the execution of strategic documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments, Expert statements for MDD, Responses to Health Authority Queries, Ad-hoc literature analyses, and labeling documents for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs. Drafting the extended synopsis of studies in collaboration with RWE experts. He/she will be responsible for overseeing the execution of such plans by the respective operational units in compliance with SOP, GCP, and other regulations. Writing of Key medical/clinical parts of Common Technical Documents (CTD) or Briefing packages (BP). Reviewing and approving compassionate use of individual medical requests for use of Sanofi medicinal products for serious or life-threatening diseases for treatment outside of clinical trials. Secure delivery of high-quality medical documents on time and in compliance with internal and external standards. Collaborates effectively with stakeholders: global medical leads/ medical product leads, global regulatory affairs, medical regulatory writing global or local teams, pharmacovigilance teams, managed access program teams. People: Maintain effective relationships with the end stakeholders (Medical, regulatory, pharmacovigilance 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 the medical regulatory writing team in developing knowledge and sharing expertise Performance: Secure deliverables (PBRER, ACO, SO, CSR, ID Cards, Investigator brochure, clinical evaluation report, briefing packages, medical section of CTA, CTD, SBRAs, MDD, HAQs or any other activities which are core activities for GMLs) are supported as per agreed timelines and quality Process: Provide medical strategic insights & evaluation related to Company's portfolio. Contribute to the management of the marketing authorization dossiers of the current related portfolio. Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries, and teams supported. Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region Work with selected vendors when required within the region to deliver the required deliverables as per the defined process Assist the head of scientific communications in designing an overall plan of action based on end-customers feedback & improving course content and delivery. Stakeholders : Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables Liaise with the Medical department to ensure relevant & customized are delivered per expectation About you Experience : 5 years of experience supporting international pharmaceutical companies: medical affairs, clinical development, pharmacovigilance with experience in at least one of the therapeutic areas- cardiovascular, metabolism, diabetes and lipid, CNS, oncology, anti-infectives, internal medicine Soft skills : Stakeholder management; communication skills; and ability to work independently and within a team environment Technical skills : As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills) Education : Medical degree MBBS; MD Languages : Excellent knowledge of the English language (spoken and written)

Hi, We are hiring for Leading ITES Company for Aggregate Report Writer Profile. Please Apply, We shall call back relevant profiles. Role & responsibilities: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.). To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

We are Hiring For Leading ITES Company for the position of PV Aggregate Reporting Role Job Descriptions To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

IPDRG Coding Specialty Training With Placement Offline Available/ Online Also CPC, CCS Certification Mandatory Training Program 2 Months after 100% Job WhatsApp - *63057 88230 Mail - balu@ssmedicode.com *SRI SAI MEDICODE - KPHB - Hyderabad.

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics and APIs, comprising Solid Dosage Formulations and Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research and Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it's a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R and D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL's full-fledged Regulatory Affairs and IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization.