64 Aggregate Reporting Jobs

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations Internal Relations Educational qualifications preferred Category Bachelor's Degree

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations Internal Relations Educational qualifications preferred Category Bachelor's Degree

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

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations Internal Relations Educational qualifications preferred Category Bachelor's Degree

As a Senior/Lead Medical Reviewer with 1 3+ years of experience in Aggregate Reporting, Signal Management, or RMP, you will play a crucial role in our team. Your responsibilities will include overseeing the implementation of operational tasks in safety writing, monitoring service performance, and mentoring employees to ensure independent work within timelines, budget, and quality standards. Your duties will involve reviewing RMP/PSUR or any aggregate documents for medical cohesiveness, managing the logistical aspects of safety reports" development, and collaborating with authors from different line functions to meet client and Health Authorities" requirements. You will also be responsible for developing and distributing project-specific slides, participating in audits and inspections, maintaining trackers, and ensuring team members complete necessary training. Additionally, you will be involved in authoring and reviewing various reports such as RMPs, DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports. Your expertise will be crucial in finalizing these reports and resolving any arising issues, as well as supporting the drafting and implementation of SOPs or WIs. You will act as a point of contact for the aggregate team and clients, assist other teams as needed, and ensure team compliance in report delivery. Desirable Skills and Experience: - Proficiency in medical and Pharmacovigilance terminologies - Knowledge of GCP, GVP, ICH, USFDA guidelines, and other relevant regulations - Basic understanding of medical and therapeutic terminology - Familiarity with patient safety regulatory obligations - Good command of written and spoken English, additional languages are advantageous - Proficiency in MS Office applications (Word, Excel, PowerPoint) - Strong soft skills, including motivation, communication competence, organizational skills, reliability, commitment, and teamwork capacity Location: Bangalore, India Education: Graduate or Post-Graduate in Life Sciences, Pharmacy, Medicine, Dentistry, Allied Health Sciences, or related fields Position: Associate Department: Pharmacovigilance and Safety Employment Type: Full Time,

• Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR for submission to local and other Health Authorities.Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations Internal Relations Educational qualifications preferred Category Bachelor's Degree

Role Name - Sr Medical safety advisor Education qualification - MBBS/MD. Location - Home Based. Work exp - Aggregate Report and Signal Mgt. Job Overview The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the products safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products. Essential Functions • Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary • Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements • Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data • Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported • Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable • Provide aggregate reviews of safety information, including but not limited to clinical data, post marketing, literature review and observational studies to maintain oversight of a products safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc) • Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective. • Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment. • Ensure update of watch list, list of expectedness, labeling list/RSIs etc. for the assigned products and develop such additional capabilities within the team • Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives • Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable • Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable • Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable • Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable • 24-hour medical support as required on assigned projects • Maintain awareness of medical safety-regulatory industry developments • Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable Qualifications • Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Req • Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req. • Two (2) years of pharma experience Pref • Sound knowledge of Medicine • In-depth knowledge of applicable global, regional, and local clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines • Knowledge of Pharmacovigilance- ICSR and Aggregate reports • In-depth knowledge of departmental standard operating procedures (SOPs) • Skill in use of multiple safety databases • Adequate Computer skills, especially Microsoft word, excel & PowerPoint • Good communication skills- verbal and written • Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients, and regulatory agency representatives • Ability to establish and maintain effective working relationships with coworkers, managers, and clients • A valid medical license, or equivalent, from the country or region in which he/she resides and works Preferred.

Role name - Assoc Medical safety director. Location - Home Based. Education Qualification - MBBS/MD. Experience - Aggregate Report and Signal Management. Job Overview Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safetys involvement on assigned trials and standalone safety projects with appropriate oversight from management or more senior medical safety directors. Essential Functions • Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary • Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements • Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported • Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a products safety profile • Provide coding review of AEs, Past medical history, Concomitant medications, or other medical data listings to verify and medically vet clinical data • Represent safety and clinical data review findings during client meetings • Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports • Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies • Provide medical oversight for label development, review, and change • Provide medical support and attendance at Data Safety Monitoring Board Meetings • Attends and contributes medical safety evaluation on Safety Monitoring Committees • Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document • Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments • Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract • Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture. • Act as Global Safety Physician or Assistant or Back-up on projects as assigned • Attend project meetings, medical safety team meetings, and client meetings as requested • Ensure coverage for all medical safety deliverables within regulatory or contracted timelines • Provide medical escalation support for medical information projects • Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects • 24-hour medical support as required on assigned projects • Maintain awareness of medical-safety-regulatory industry developments Qualifications • Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req • Three (3) years of clinical practice experience (e.g. graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training, and experience Req • Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice • Knowledge of clinical trials and pharmaceutical research process • Ability to establish and meet priorities, deadlines, and objectives. • Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility. • Ability to establish and maintain effective working relationships with coworkers, managers, and clients • A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref.

Medical Review aggregate reports (PSUR, PBRER, ADCO & DSUR) and screening of scientific literature for periodic submission as per the Regulations and SOPs. Manage daily workload in conjugation with line manager for aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department. Generation and review of SOPs and WIs and execution of company SOPs. Compliance to project guidelines • Execution of Company Standard Operating Procedures Maintain awareness of changes to/new regulations affecting PVG activities. Trains and mentors new medical reviewers in PVG (if required). To carry out necessary administrative duties required for the job. Other duties as assigned by management. Builds and maintains good relationships across functional units and company affiliates. Preferred candidate profile Proficiency in Aggregate Report. Well versed with technical writing requirements for US and EU. Good therapeutic knowledge.

Project role : Safety Aggreg Report Spec 1 Work experiences : 2 to 6 years. Work location : Hybrid Must have skills : "Aggregate Report", PBRER, PSUR, DSUR, PADER, "Signal Management", "Signal Detection" Essential Functions : Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings 3 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. Conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks

As a Project Lead, your responsibilities will include leading and managing projects, supervising all project-related activities, and facilitating communication between the Project Manager and the team. You will be tasked with recording, maintaining, and tracking metrics for both team members and project performance. Additionally, you will review and evaluate AE case information to determine required actions based on internal policies and procedures. Your role will also involve processing current incoming cases to meet Regulatory timelines, providing guidance for data entry, following up with sites regarding outstanding queries, and addressing reconciliation discrepancies. It is essential to adhere to departmental AE workflow procedures and train and mentor new team members as per project requirements. Moreover, you will be expected to author/draft aggregate reports and quality reviews such as PBRER, PSURs, PADER, Addendum to Clinical Overviews, RMP, and Signal detection reports. The ideal candidate should have 7-10 years of relevant experience and hold a qualification of MBBS/MD/M.Pharm. This position is based in Hyderabad.,

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations Internal Relations Educational qualifications preferred Category Bachelor's Degree

Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR for submission to local and other Health Authorities. Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities. Authoring of Signal Management Reports. Performing literature search and validity check for the aggregate reports. Reconciliation of relevant process trackers. Extraction and validation of data (RSI, Sales, previous reports, RMP, signals). Generation of Line Listings (LL) from safety database Providing reliable support for high priority Ad-hoc activities. Ensure all the reports are drafted within the allocated timelines.

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

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations Internal Relations Educational qualifications preferred Category Bachelor's Degree

Role & responsibilities Contributing to maintain or improve quality performance and compliance of operational PV activities Ensuring Deviation and CAPA Management, Change Control, Document Control, and other Quality Management System activities Developing, managing, and executing quality management processes to ensure quality standards are maintained and compliant with regulatory requirements Coordinating PV audits and Inspections Preparation and management of Pharmacovigilance System Master File (PSMF) Generation, quality review, and distribution of compliance and quality metrics and trending activities. Coordinating compliance, quality, and process improvement initiatives while providing input into corrective/preventative actions and effectiveness measures for Corrective and Preventative Action plans (CAPA), as appropriate Preparation, review, and maintenance of safety data exchange agreement/pharmacovigilance agreement/any other agreement. Management of the Quality document (SOPs/Policy/Conventions) planning and their compliance. Training management and documentation Ensuring the third parties (Business partners and vendors) qualifications and its documentation Collaborating with key stakeholders to ensure metrics meet oversight needs Coordinate with vendor for activities like Computer system Validation, User Management, Database Training, WHODD, MedDRA Version update, etc Continuous Monitoring of Regulatory Requirements (Surveillance) Management of Company Product Dictionary Handling archival and retrieval activities of pharmacovigilance-related documents Preferred candidate profile Candidate must have minimum 3 years experience in PV-Compliance. Candidate must have relevant knowledge of all PV areas like ICSR, aggregate reports, medical writing etc.. Candidate must be ready to work in 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

Were Hiring: Specialist Patient Safety Are you a passionate life sciences professional with expertise in Pharmacovigilance and Patient Safety? Location: Mumbai Key Responsibilities: * Draft and review PSURs, PBRER, PADERs, and signal reports (DSR, DEP, SAR). * Author ad hoc safety documents (RMPs, CES, HA responses). * Contribute to ongoing improvement of PV systems & compliance. * Support clinical evaluations and regulatory inspections. * Monitor global PV requirements (Europe & RoW). * Collaborate with cross-functional teams and represent the company at scientific meetings. Qualifications: * MBBS Skills & Experience: * 2+ years in Pharmacovigilance / Drug Safety * Experience with signal detection, medical writing, and safety database compliance. * Strong knowledge of GVP regulations, safety audits, and variation submissions. Interested? Apply Now or Share Your CV at: swati.dussa@peoplesense.in or 9321287591

Roles and Responsibilities Perform medical review of Individual Case Safety Reports (ICSRs) , Serious Adverse Events (SAEs), and SUSARs Conduct causality and seriousness assessments of adverse events Validate case narratives and ensure medical accuracy and regulatory compliance Participate in safety signal detection and risk evaluation Contribute to the preparation and review of aggregate reports : PSUR, PBRER, DSUR, RMP Support updates to product safety labels (SmPC, PI) based on current safety data Collaborate with regulatory, clinical, and medical affairs teams for cross-functional safety activities Provide clinical input on global pharmacovigilance strategies and safety documents Respond to regulatory authority inquiries regarding safety issues Qualifications MBBS / MD (Pharmacology, Internal Medicine, or equivalent) Mandatory Minimum 2-5 years of experience in pharmacovigilance or clinical safety Prior experience in medical review of PV cases and signal management preferred Familiarity with ICH-GCP , MedDRA , WHO-ART , and global regulatory guidelines Experience with Argus / ARISg or other PV databases is a plus Excellent written and verbal communication skills Interested to apply can share CV or call/WhatsApp to 9342735755

Job Description Drug Safety Physician At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization in developed and emerging markets. We are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk management activities and drive proactive implementation of risk management initiatives to meet global regulatory requirements. The right candidate will have leadership skills, be an excellent communicator with an ability to have oversight over CRO activities and can successfully lead and influence external and internal stakeholders. DSP also serves as a subject matter expert for product-specific safety information. Responsibilities: Contributes to the development & maintenance of product safety profile. Involved in all safety surveillance activities, which may include monitoring of adverse event and all other safety information to manage the safety profile of the company products Collaborates with, medical monitors and other functional groups in identification, analysis, and reporting of possible safety-related trends or concerns. Responsible for the evaluation of safety data from pre-clinical studies, clinical studies, literature and other sources to establish safety profile of company products to manage risk to the patients Provides medical input into the identification and utilization of appropriate sources of information and database searches to retrieve relevant data for signal evaluation Discuss results of data evaluation with pharmacovigilance safety review team, drug safety committee and/or other key stakeholders Provides inputs to literature search strategy and review to effectively determine appropriate and relevant literature for the purposes of safety analysis. Responsible for the review of the Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategy (REMS) providing expertise to the medical content of the safety specification, risk management plan, risk minimisation measures including the locally implemented risk minimisation measures and drives the implementation of risk minimisation activities in accordance with global regulatory requirements. Provides medical input in ensuring that risk minimisation strategies are implemented appropriately in relevant documents such as product reference safety information Collaborates with external provider representatives in the preparation and review of aggregate reports having thorough oversight over the critical aspects like summary of safety concerns, benefit risk evaluation, conclusion etc Have thorough medical oversight over the external vendors on the medical review of ICSRs Provides medical inputs to deliver accurate safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data Provides medical inputs in responding to safety questions from regulatory authorities and partners in collaboration with service providers and cross-functional teams Review and provides medical inputs to the safety sections of CCDS, local label updates, health hazard analysis, QA trend analysis, device hazard lists, CER etc Understands the role of QPPV and contributes to the maintenance of the pharmacovigilance system and process Provides inputs to various pharmacovigilance documents like PSMF, SDEA Provides input and review for key regulatory or clinical documents (i.e. SMP, protocol, IB, SAE/SUSAR, safety sections of DSUR, ASR, CSR, integrated summaries of safety etc.) related to pharmacovigilance Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, signal management, risk management plan preparation and responding to ad-hoc safety questions Participates and supports pharmacovigilance audit/inspection preparation and CAPA management Participates in internal pharmacovigilance committee meetings as well as joint safety meetings with partners. Provides inputs in the preparation/revision of SOPs, working guidance and ensuring pharmacovigilance compliance. Meets pharmacovigilance commitments to regulatory authorities with respect to marketing authorization. Follows good pharmacovigilance practices (ICH, Eudravigilance, local regulations etc). Trains and mentors the team members. Other Drug Safety Physician responsibilities include: Accountable for maintaining personal readiness in response to internal audit or regulatory inspection Includes knowledge of case processing, expedited reporting and safety database concepts Proactively raises concerns/issues to senior management in a timely and appropriate manner ensures quality and integrity of the issue/event being escalated Demonstrates leadership and interacts collaboratively and effectively in team environment (including safety, clinical development, medical affairs,regulatory, commercial, devices) as well as with external stakeholders Must be an excellent communicator and have strong negotiation skills with an ability to have oversight over CRO activities Strong organisational skills, including capability to prioritise independently with minimal supervision. Qualifications MBBS/PhD/MD with 12+ years of pharmacovigilance experience in the pharmaceutical industry, clinical care setting, or Academia Knowledge of the biopharmaceutical industry, drugs and indications with an understanding of applicable guidelines, regulations and best practices for conduct of pharmacovigilance activities. High degree of professionalism, maturity, business understanding and passion. Strong written and verbal communication skills as well as strong interpersonal skills, with impeccable attention to detail Ability to collaborate effectively with internal and external stakeholders at all levels and influence decision-making. Must have knowledge of common data processing software like MS office tools (Excel, Power Point, Microsoft Word etc) Job Location: Bangalore, India.

Manager - DSRM (Aggregate and SDEA) 1. Managing the Safety Data Exchange Agreement mailbox, to track the emails received and ensure appropriate action is taken. 2. To ensure appropriate agreements are in place with prospective and existing business partners and ensure timely execution and renewal of agreements 3. To liaise with cross functional teams to seek additional information 4. To ensure compliance to the agreements and be audit / inspection ready. 5.Preparing and maintaining the aggregate report writing plan to plan and keep a track of the global aggregate report submissions 6. Preparing and maintaining the aggregate report compliance tracker and ensuring compliance and appropriate corrective and preventive actions 7. Maintenance and regular update of global / regional risk management measures tracker 8. Ensuring the implementation of additional risk minimization measures (aRMMs) and timely evaluation of the effectiveness check of additional risk minimization measures for Lupin products globally 9. To liaise with cross functional teams like regulatory affairs, marketing, local affiliates in ensuring appropriate implementation of the risk management plan. Competencies Developing Talent Result Orientation Customer Centricity Strategic Agility Process Excellence Innovation & Creativity Stakeholder Management Collaboration B. Phram / M. Pharm Graduation Masters in Pharmacy 7-8 years of experience in Aggregate Reports, Buiseness partner agreements 7-8 years of experience in Aggregate Reports, Risk Management Plans and Business partner agreements.

We are looking for MBBS - Medical Reviewer with 2-3 years of experience in Pharmacovigilance having expertise in review f aggregate reports. Candidate who are willing to come to office and work from office only can apply. Designation : Asst. Manager Department : Vigilance Competence Center Gurgaon, Qualification : MBBS/MD with 2-3 years of experience in pharmacovigilance with expertise in medical review of aggregate reports (PSURs/PBRERs) (required), with experience in performing medical review of signal management and ICSRs (recommended). Location : Gurgaon (Work from office is must with one-day flexi working option) Job Responsibility Design, develop and maintain procedures for medical review activities (ICSRs, aggregate reports and signal management). Ensure high quality of ICSR, aggregate and signal management deliverables. Perform medical review of ICSRs, aggregate reports (PSURs/PBRERs), Risk Management plans, and signal reports. Participate in/organize review of safety label updates. Mentor and train medical reviewers. Provide product and therapeutic area trainings for the PV team. Provide cross-functional training on pharmacovigilance to medical writing and ICSR team members. Behavioral Competencies Excellent interpersonal communication and writing skills with experience handling cross-functional projects Good conflict resolution skills Ability to work in a multi-cultural/global work environment Good mentoring skill

Level A4 – 3+ years Associate - Scientific Writing_Aggregate reporting Locations – across any nodal offices/Hybrid **Job Description:** **Responsibilities:** - Responsible for the entire document life cycle, maintaining quality, timeliness, and compliance with internal/client SOPs and regulations. - End-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, PSURs, SUSAR, PADERs/PAERs, ACOs, RMPs , and ad-hoc regulatory and safety reports. - Perform QC review of documents to validate accuracy and relevance, ensuring compliance with client-specific style and global standards. - Assist and mentor junior writers, provide guidance, and ensure consistency and completeness of reports. - Continuous process improvement in the team for developing content. - Participate in assigned training programs and create training materials and guidelines. - Interface with clients regularly to meet their expectations. **Qualifications:** - Medical/M.Pharm/Pharm D/life sciences degree. - Minimum 4 years of experience in medical writing or equivalent life sciences domain experience. - Knowledge of regulatory documentation, drug development process, and global regulations. - Excellent written and verbal communication skills, organizational and time management skills, and strong data interpretation and presentation skills. - Strong interpersonal skills and the ability to be flexible in varying environments. Indegene is proud to be an Equal Employment Employer committed to Inclusion and Diversity. We do not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions will be based on business requirements, the candidate’s merit, and qualifications. We are an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to any protected characteristics. Thank you for your attention to this matter. We look forward to receiving suitable profiles from you soon.

Job Title - Safety Aggregate Report Specialist 2. Skills required - Signal detection/Signal Management. Years of exp required - 4+ yrs exp in Signal Mgt. Work location - Anywhere in India. Work Mode - Hybrid/Remote. Job Overview. Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. • Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). • Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings • author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. • Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. • Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterization of risks. Responsible for full documentation and tracking of signals. • In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. • Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. • Participate in internal and external audits and inspections, as required. • Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. • Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. • Serve as the interface between the global project lead and the working team • conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. • Provide mentorship and training to less experienced resources. • Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns • participate in project review meetings with management • communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). • Support and/or contribute to technology / innovation activities. investigators, medical monitors, site coordinators and designees to address project related issues. • Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes. • To liaise with client in relation to details on day to day activities as needed. • Contribute to achievement of departmental goals • Perform other duties as assigned