Periodic Reporting Expert

5 days ago

Remote, India IQVIA Full time

Shared INN PSR management
- Provides Global PSR format training to new and contributors, provides mentorship for new PREs;
- SME in inspections, internal and partner audits to communicate PSR processes and expectations as defined in quality documents;
- Implements process and quality document changes when regulatory requirements change or process improvements are identified;-Coordinates, collects contributions from regulatory and clinical departments, obtains cumulative exposure data, authors the pharmacovigilance content either alone or in collaboration with GSOs (Global Safety Officers), including signal detection analyses, RMP information, and compiles all information received and/or authored into a final document ready for publishing;
- 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 Pharmacovigilance contribution to PSRs to ensure regulatory submission compliance;
- Oversees the coordination, collection, and authoring of Global PSRs by vendor according to an existing outsourcing strategy, provides the necessary training, mentorship, and provides constructive feedback to ensure adherence to quality document requirements; ensures self QC and peer QC is documented and fed through the quality improvement process;
- The PRE is expected to foster productive relationships with cross-functional teams that appropriately represent the PRE team as a whole;
- Accountable for complying PSR 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 procedures and or reports that are at risk for being late for completion and distribution/submission;
- Accountable for the maintenance of the appropriate documentation utilized during Global PSR authoring in customer’s document management system;
- Participates in Health Authority assessment report responses in collaboration with the GSO and QPPV as it relates to Pharmacovigilance content as well as with regulatory and other stakeholders;
- Coordinates and participates in responding to health authority and partner questions regarding the Global PSR content and processes;
- Responsible for PSR quality and compliance oversight and continuous improvement of processes;
- Accountable for complying to timeline expectations and for the accurate and reliable tracking of quality and compliance metrics for Global PSRs;
- Supports/provides the root cause analyses associated with quality and compliance deviations.
- trains and mentors new staff

  • Periodic Report Exp Oversight

    2 weeks ago

    Remote, India IQVIA Full time

    Provides Global PSR format training to new staff and contributors, provides mentorship for new PREs. - SME in inspections, internal and partner audits to communicate PSR processes and expectations as defined in QDs. - Implements process and QD changes when regulatory requirements change, or process improvements are identified. - Coordinates, collects...

  • Reporter

    1 week ago

    Remote, India Norstella Full time

    **Description** **About Norstella**: At Norstella, our mission is simple: to help our clients bring life-saving therapies to market quicker—and help patients in need. Founded in 2022, but with history going back to 1939, Norstella unites best-in-class brands to help clients navigate the complexities at each step of the drug development life cycle —and...

  • Sustainability Reporting Expert

    1 week ago

    Remote, India EU Tech Chamber Full time

    The European Technology Chamber is a registered NGO that enables European companies to use their technologies for the benefit of Europe and mankind - following our vision "Technology obliges". As Europe’s leading tech network, we are constantly enlarging our team to serve our network even better. We are currently building our team and now searching...

  • Reporting Consultant/Developer

    1 week ago

    Remote, India InfoVista Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    The RoleWe're looking for a dynamic Reporting Consultant/Developer to develop reports and customise KPIs for our early customer engagements in our Network Testing product lines in the CSP sector. Infovista has a new product offering, and we require someone with very strong reporting skills, who can take customer requirements and create a solution based on...

  • Certified Oracle Fusion Finance

    1 week ago

    Remote, India Blue Ocean Systems Infotech Pvt. Ltd. Full time

    Hi **Immediate Hiring - Offshore / Remote Work** **Time**: 9 AM to 5 PM KST (5:30 AM to 1:30 PM IST) **Mode**: Remote / Offshore **Certified Oracle Fusion Finance (Cloud) Expert** - At least 7 years’ experience providing functional and technical support for the Oracle Fusion Finance (Cloud) modules as scoped above, including supporting enhancements,...

  • Stock Market

    1 week ago

    Remote, India MB Full time

    **Looking for someone who is expert and profitable in stock market.** **Please answer following question during interview.** 1. Has the ability to generate good return in swing trading. 2. Know how to generate Alpha in compare to ETF's. 3. Can identify stocks that can generate 10-15% retun in a short period of time. 4. Please share how much return you...

  • Servicenow Expert

    6 days ago

    Remote, India Vtricks Technologies Full time

    **Job Description: ServiceNow Expert (Remote)** **Position**: ServiceNow Expert **Experience**: 4 to 6 Years **Location**: Remote **Employment Type**: Full-Time **About the Role**: **Key Responsibilities**: **ServiceNow Implementation & Customization**: - Implement and configure **various ServiceNow modules** (ITSM, ITOM, ITBM, CSM, HRSD, SecOps, etc.). -...

  • Consultant - Operations, Monitoring & Reporting

    1 week ago

    Remote, India Dhiraa SkillDev Foundation Full time ₹ 1,80,000 - ₹ 2,40,000 per year

    Consultant - Operations, Monitoring & ReportingCoordinating operations, monitoring program delivery, and preparing reports for our funders. You will support both on-ground and online execution, maintain records, and ensure effective communication with community beneficiaries, trainers, and stakeholders.Key ResponsibilitiesOperations & CoordinationCoordinate...

  • Doubt Solving Expert

    6 days ago

    Remote, India Kunduz Technologies private limited Full time

    **Selected Subject Matter Expert's day-to-day responsibilities include**: - Work on solving doubts & writing solutions for students' live questions in Physical Chemistry. - Write answers in blue or black ink on a blank piece of white paper, take a snapshot, and upload solutions on the app. - Write detailed & readable step-by-step solutions to be understood...

  • Ai & Automation Expert - SEO/content

    2 weeks ago

    Remote, India FullStackTechies Full time

    **AI & Automation Expert - SEO/Content (Digital Marketing)** Experience: 3 to 8 years Location: Work from Home/Bangalore/India CTC: 10 lacs to 20 lacs INR per annum Work Time: 9 am IST to 6 pm IST (Flexi Time) No of positions: 2 Educational qualification: MBA/PGDM/Engineering Industry: Digital Marketing / IT-ITES Notice Period**:Immediate - 2...