17 Pader Jobs

Medical Reviewer Responsible for Medical review of Company and Literature and Regulatory cases Appropriate selection of adverse events and assessment of seriousness criteria MedDRA Coding of the adverse events Review of reporter/company causality and Label assessment Selection of product role (suspect, concomitant or interacting) and concomitant conditions, medical history, and laboratory data Case Narrative evaluation Drafting/Quality/Medical review of aggregate reports (Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs) Medical review of Risk Management Plans (RMPs) Medical review of Signal Management Reports Preferred candidate profile MBBS or MD doc...

As a Regulatory Affairs Specialist, you will be responsible for leading regulatory submissions for Inhalation, Nasal, Oral Solid Dosage (OSD), Contract Manufacturing, and Strategic Alliance projects for the US market. Your role will involve ensuring timely and compliant responses to product deficiencies raised by US regulatory authorities, including the USFDA. Additionally, you will manage post-approval submissions and annual reports for USFDA-approved products to ensure continuous regulatory compliance and lifecycle management. Key Responsibilities: - Drive labeling updates in alignment with changes to Reference Listed Drug (RLD) labeling approved by the USFDA. - Provide regulatory support ...

Skill required: Pharmacovigilance Operations - Safety Writing Designation: Delivery Operations Associate Manager Qualifications: MBBS/MD Years of Experience: 7 to 10 years What would you do Responsible for medical review of the aggregate reports (PSUR/PBRER, PADER and other AR reports) and RMP report within agreed timeframes and to a high standard of accuracy, in compliance with client’s standard operating procedures and global regulatory requirements. What are we looking for Hands on experience of medical review of PBRER, PSUR, RMP and other aggregate report writing.Hands on experience of medical review of PBRER, PSUR, RMP and other aggregate report writing. Roles and Responsibilities: Part...

This position plays a role in the authoring, compilation and peer review of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e g Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form In compliance with global regulatory requirements This role supports the end-to-end writing and documentation process and ensures timelines are met Key Responsibilities:Compilation and authoring o...

The primary responsibility of this role is to perform quality control reviews of of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures t...

Role & responsibilities 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. Essential Functions : • 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,...

Job Role : Pharmacovigilance (Aggregate Reporting) Designation : Assistant Manager Job Description: Preparation and review of aggregate reports such as Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Risk Management Plans (RMPs), Addendum to Clinical Overview (ADCO) etc. Co-ordination with various stakeholders to gather data required for Aggregate reports. Work closely with service providers and resolve their queries. Co-ordinate with various stakeholders internal and external required for the completion reports. Preparation and review of Query responses from Regulatory Authority Job Specification : B. Pharm/ M. Pharm with 6-12years of ex...

About The Role Skill required: Pharmacovigilance Operations - Safety Writing Designation: Delivery Operations Associate Manager Qualifications: MBBS/MD Years of Experience: 7 to 10 years 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 count...

This position plays a role in the authoring, compilation and peer review of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/ Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. In compliance with global regulatory requirements. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Compilation and autho...

Aggregate Report Specialist JOB DESCRIPTION Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title: Aggregate Report Specialist Location: Bengaluru/Mysore - Hybrid Function: Drug Safety DESCRIPTIO...

As a Regulatory Affairs Specialist in our company, your role will involve the following key responsibilities: - Ensuring timely response to deficiencies raised by Agency on ANDAs. - Reviewing all specifications and proposals from sites of approved ANDAs for supplement filings. - Providing regulatory support and reviewing pre-filing and development documentation such as development reports, BMR, BPR, specifications, method validation, process validation, change control, etc. - Authoring, compiling, and reviewing ANDA dossier in eCTD format and structured product labeling (SPL), followed by publishing, validation, and submission of the dossier. - Submitting PADER to comply with USFDA requireme...

Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases and signal detection. Writing Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update Reports (DSUR), Addendum to the Clinical Overview (ACO), Periodic Adverse Drug Experience Report (PADER), and Clinical Expert Statements., Publishing, distribution, archiving and submission of safety reports. Preparation of Signal detection reports, including EVDAS screening if applicable. Preparation of SARs (Signal Assessment Reports). Writing Risk Management Plans (RMPs). Identifying safety concerns and providing advice with regard to future ri...

Experience in handling various aggregate reports including PADERs, PSURs/PBRER, ACOs. Experience in running routine signal detection process, including review of individual case reports, literature review in coordination with QPPVs/safety physicians. Coordination and good communication with cross functional teams. Required Qualification : B.Pharmacy/M.Pharmacy/Pharma.D

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 ma...

Minimum of 8 years experience in handling Aggregate reports such as PBRERs/PSURs, PADERs, RMP and Signal Management reports. To lead the aggregate reporting team, and to schedule and ensure regulatory compliance in preparation, review and reporting of aggregate reports (PADERs andPBRERS/PSURs), signal reports, risk management plan reports. To oversee the assignment of activities within the team and ensure the timely delivery and appropriate quality oversight of aggregate reports. Ensure tasks are performed as per applicable procedures (e.g., WI, SOPs) assigned to the role. To provide response to the regulatory queries on safety topics and relevant documents in support to content of safety. Q...

Role & responsibilities To prepare and review and reporting of aggregate reports (PADERs and PBRERS/PSURs), signal reports, risk management plan reports. To oversee the assignment of activities within the team and ensure the timely delivery and appropriate quality oversight of aggregate reports. Ensure tasks are performed as per applicable procedures (e.g., WI, SOPs) assigned to the role. To provide response to the regulatory queries on safety topics and relevant documents in support to content of safety. To liaise with cross-functional departments such as Regulatory Affairs and Medical Review to ensure seamless coordination of safety-related activities. To establish and maintain effective c...

The Pharmacovigilance (PV) Scientist supports the activities in the Benefit Risk group by ensuring that day-to-day operational activities are completed. The PV Safety Scientist is expected to be professional and diligent and liaise with the director and management group members within the team on any issues, as well as coordinate the work with the senior PV Scientists. The PV Safety Scientist is also expected to lead by example and ensures quality standards are upheld within the company. Role & responsibilities 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 pa...