![Zaportiv](https://media.trabajo.org/img/noimg.jpg)
Safety Aggreg Reporting
1 week ago
Job Title:
Safety Aggreg Reporting
Total Experience: 3 -6 years
Relevant Experience: 3+ yearsLocation: Bangalore
Notice Period:
Immediate
Roles and ResponsibilitiesJob Profile SummaryTitleBill RateExpSafety Aggreg Report Spec1-3 LPA3-4 yrs Pharmacovigilance 0-2 yrs Aggregate ReportingSafety Aggreg Report Spec2-5 LPA4-6 yrs Pharmacovigilance 2-4 yrs Aggregate ReportingSafety Aggreg Report Mgr8 LPA6+ yrs Pharmacovigilance 4+ yrs Aggregate Reporting
Apply knowledge and expertise for Safety Aggregate Report and Analytics(SARA) Centre deliverables including safety aggregate reports, literaturesurveillance, signal management activities and benefit-risk managementdocuments
Roles and ResponsibilitiesServe as principal owner of the SARA deliverable and have responsibility for the 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.
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' signalling strategies. The author and/or QC review all types of signal management deliverables.Lead/ conduct ongoing signal detection activities as per agreed signalling 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 asRegulatory 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.-
Safety Reporting Coord
1 week ago
Bengaluru, Karnataka, India Thermo Fisher Scientific Full timeWe are vital links between an idea for a new medicine and the people who need it.We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...
-
Safety Reporting Coordinator
1 week ago
Bengaluru, Karnataka, India Thermo Fisher Scientific Full timeAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Safety Writer
1 week ago
Bengaluru, Karnataka, India Lifelancer Full timeJob Description Summarized Purpose: Responsible for the planning, coordination and delivery of safety writing services for multiple clinical trial and/or marketed product projects. Performs day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. Activities include but are not...
-
Safety Surveillance Advisor I
1 week ago
Bengaluru, Karnataka, India Novo Nordisk Full timeDepartment: Global Safety - Global Business Services (GS-GBS) Are you someone who thrives on challenges and enjoys working in a dynamic setting? Do you excel in environments where close collaboration with key stakeholders and strategic alignment is crucial? Is continuous improvement a key career goal for you? If so, we may have the perfect opportunity for...
-
Safety Medical Writer
1 week ago
Bengaluru, Karnataka, India Novo Nordisk Full timeDepartment - GS GBS Safety Medical WritingThe PositionAs a Safety Medical Writer (SMW), you will plan, drive and co-ordinate preparation of safety documents to ensure submission according to agreed timelines. You will prepare aggregate safety reports, clinical risk management plans and responses to questions from health authorities in collaboration with...
-
Safety Surveillance Advisor I
1 week ago
Bengaluru, Karnataka, India Novo Nordisk AS Full timeDepartment: Global Safety - Global Business Services (GS-GBS).Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives?...
-
Safety Surveillance Advisor I
1 week ago
Bengaluru, Karnataka, India Novo Nordisk AS Full timeDepartment : Global Safety - Global Business Services (GS-GBS). Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career...
-
Lead Safety Science Specialist
1 week ago
Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Safety Writer Ii
1 week ago
Bengaluru, Karnataka, India Thermo Fisher Scientific Full timeSummarized Purpose:Responsible for the planning, coordination and delivery of safety writing services for multiple clinical trial and/or marketed product projects. Performs day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines.Activities include but are not limited to delivery of...
-
Safety Surveillance Adviser I
1 week ago
Bengaluru, Karnataka, India Novo Nordisk Full timeSafety Surveillance Adviser ICategory:Reg Affairs & Safety PharmacovigilanceLocation:Bangalore, Karnataka, INDepartment : Global Safety Global Business Service (GS-GBS).-The Position As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the labelling for marketed...
-
Safety Surveillance Adviser I
1 week ago
Bengaluru, Karnataka, India Novo Nordisk Full timeSafety Surveillance Adviser ICategory:Reg Affairs & Safety PharmacovigilanceLocation:Bangalore, Karnataka, INDepartment : Global Safety - Global Business Services (GS-GBS).-The Position As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the labelling for marketed...
-
Lead Safety Science Specialist
1 week ago
Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Safety Surveillance Adviser I
1 week ago
Bengaluru, Karnataka, India Novo Nordisk Full timeDepartment : Global Safety Global Business Service (GS-GBS).The PositionAs a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the labelling for marketed products. Furthermore, perform ongoing and systematic surveillance of Novo Nordisk (NN) products during pre-approval...
-
Manager Traded Risk Aggregation
1 week ago
Bengaluru, Karnataka, India HSBC Full timeDescription - External Some Careers grow faster than others. If you're looking for a career where you can make a real impression, join HSBC and discover how valued you'll be. HSBC is one of the largest banking and financial services organisations in the world, with operations in 64 countries and territories. We aim to be where the growth is,...
-
Deputy Affiliate Safety Representative
1 week ago
Bengaluru, Karnataka, India ABBVIE Full timeJob Summary:To actively support ASR in the coordination and execution of all aspects of pharmacovigilance at the affiliate to ensure that AbbVie's statutory and ethical responsibilities are met. Act as Back up for Affiliate's main contact point for pharmacovigilance matters with the National Regulatory Agency and AbbVie Pharmacovigilance and Patient Safety...
-
Dh Safety
1 week ago
Bengaluru, Karnataka, India Aditya Birla Group Full timeDesignation:General ManagerUpdated:November 16, 2023Location:Karnataka, IndiaOrganization:CementKRA 1: Accountability - Organise & coordinate with departmental heads and monitor implementation of safety practices in the plant to achieve zero accident target. - Plan inspections, develop checklists, Monitor the Implementation, Participation in departmental...
-
Safety Officer
1 week ago
Bengaluru, Karnataka, India TVS Supply Chain Solutions Full timeInvestigate unsafe act and conditions and to provide solutions to prevent recurrences. Provide daily. Weekly & Monthly summary report of field HSE issues. HSE documentations, Risk assessments, JSAs, Toolbox talks. Provide necessary training for Staff in relations to health & safety policies, practices and procedures. Ensure all personnel and necessary...
-
Safety Supervisor
1 week ago
Bengaluru, Karnataka, India DS-MAX Properties Pvt. Ltd. Full timeYears of Experience: 5 – 10 YearsQualification: Any Graduate / Post GraduateJob DescriptionEnsure the Project Safety Plan is maintained and implemented on-site.Undertake a regular review of health and safety performance in the project and work with the site team to ensure that standards are conveyed and adopted on-site.Conduct regular health and safety...
-
Safety Officer
1 week ago
Bengaluru, Karnataka, India Sansera Engineering Full timeJob Summary:Key Responsibilities: Develop and implement safety policies and procedures to comply with local, state, and federal regulations Conduct regular safety inspections and audits to identify potential hazards and risks in the workplace Train employees on safety protocols and procedures and ensure that all staff members are aware of and adhere to...
-
Safety Assurance Engineer
1 week ago
Bengaluru, Karnataka, India Alstom Full timeReq ID:433534We create smart innovations to meet the mobility challenges of today and tomorrow. We design and manufacture a complete range of transportation systems, from high-speed trains to electric buses and driverless trains, as well as infrastructure, signalling and digital mobility solutions. Joining us means joining a truly global community of more...