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Primevigilance

PrimeVigilance is a global pharmacovigilance and drug safety services provider focused on ensuring the safety of drugs within the pharmaceutical and biotechnology sectors.

17 Job openings at Primevigilance
Senior Statistical Programmer

Pune

3 - 7 years

INR 5.0 - 9.0 Lacs P.A.

Work from Office

Full Time

The Statistical Programmer (SP) within the Ergomed Biostatistics (BS) department is responsible for the creation of SDTM/ADaM datasets and programming tables, listings and figures or other types of output, supporting and complimenting the biostatistician(s) of a project and creating and maintaining appropriate documentation. The Statistical Programmer is accountable for the first-time quality of the product, either dataset or output, via thorough QC steps. Role and Responsibilities Maintains responsibility for all assigned duties within a clinical study, this may include: Ensuring that work is performed on time Ensuring all content created/reviewed is appropriate, valid, and relevant to the study and of high quality Works with other biometrics team members to represent the needs and input of the programming components of the study Program SDTM and ADaM datasets Create SDTM and ADaM specifications Create CDISC submission packages e.g. Define.xml and Reviewers Guide Program tables, listings, and figures in SAS from specifications Deliver training and mentorship to SP and other operational staff, as applicable Contribute to the development of the department in supporting adherence to good programming and best practices by contributing to training, development of macros and standard processes, input and/or review of controlled documents, or other related content Act as a statistical programming expert and provide consultative support to internal programmers and biostatisticians with any programming related topics Act as a program or sponsor lead across multiple studies, clinical programs, and/or large complex studies with responsibility for all statistical programming activities and ensuring consistency across multiple studies Develop innovative techniques to solve complex programming problems on a clinical study or program of clinical studies to increase efficiency Assist their manager with programming work projections to aid departmental planning Represent statistical programming in client or agency study audits Supports the Head of Biostatistics, or Manager/Director, Statistical Programming on topics related to programming issues, process improvement, industry trends, and other relevant topics Excellent knowledge and understanding of SAS Base, Macro and ODS Education Bachelors Degree, preferably in Computer Science, Mathematics/Statistics, or a quantitative natural science. Thorough knowledge of SAS programming and statistical programming topics

Senior Statistical Programmer

Pune

3 - 7 years

INR 5.0 - 9.0 Lacs P.A.

Work from Office

Full Time

The Statistical Programmer (SP) within the Ergomed Biostatistics (BS) department is responsible for the creation of SDTM/ADaM datasets and programming tables, listings and figures or other types of output, supporting and complimenting the biostatistician(s) of a project and creating and maintaining appropriate documentation. The Statistical Programmer is accountable for the first-time quality of the product, either dataset or output, via thorough QC steps. Role and Responsibilities Maintains responsibility for all assigned duties within a clinical study, this may include: Ensuring that work is performed on time Ensuring all content created/reviewed is appropriate, valid, and relevant to the study and of high quality Works with other biometrics team members to represent the needs and input of the programming components of the study Program SDTM and ADaM datasets Create SDTM and ADaM specifications Create CDISC submission packages e. g. Define. xml and Reviewers Guide Program tables, listings, and figures in SAS from specifications Deliver training and mentorship to SP and other operational staff, as applicable Contribute to the development of the department in supporting adherence to good programming and best practices by contributing to training, development of macros and standard processes, input and/or review of controlled documents, or other related content Act as a statistical programming expert and provide consultative support to internal programmers and biostatisticians with any programming related topics Act as a program or sponsor lead across multiple studies, clinical programs, and/or large complex studies with responsibility for all statistical programming activities and ensuring consistency across multiple studies Develop innovative techniques to solve complex programming problems on a clinical study or program of clinical studies to increase efficiency Assist their manager with programming work projections to aid departmental planning Represent statistical programming in client or agency study audits Supports the Head of Biostatistics, or Manager/Director, Statistical Programming on topics related to programming issues, process improvement, industry trends, and other relevant topics Excellent knowledge and understanding of SAS Base, Macro and ODS

Junior PV Officer/PV Officer

Pune

1 - 4 years

INR 2.0 - 5.0 Lacs P.A.

Work from Office

Full Time

At PrimeVigilance, Junior PV Officer/ PV Officers are experienced case processing team members who are expected to manage a variety of case processing and quality review activities with minimal guidance from senior team members. Responsibilities include: Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps. Reconciliation activities for all types of received reports Workflow management activities

Junior PV Officer/PV Officer

Pune

1 - 4 years

INR 3.0 - 6.0 Lacs P.A.

Work from Office

Full Time

At PrimeVigilance, Junior PV Officer/ PV Officers are experienced case processing team members who are expected to manage a variety of case processing and quality review activities with minimal guidance from senior team members. Responsibilities include: Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps. Reconciliation activities for all types of received reports Workflow management activities Requirements: Life science / bio medical background - healthcare related degree (chemistry, biology, biotechnology, veterinary science) Demonstrated full start to finish case processing experience and quality review exp

PV Officer, Team Leader

Pune

2 - 5 years

INR 4.0 - 7.0 Lacs P.A.

Work from Office

Full Time

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them. The PV Officer should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc. ) and have demonstrated experience in case processing. The PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance. PV Officers are expected to reach and maintain a high level of performance within 3 months of being assigned to an ICSR team, following onboarding completion. Responsibilities include: Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review. Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations) Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc. ) Mentoring and training of new and more junior employees within the department, including procedure optimization and development

Project Finance Analyst

Pune

2 - 5 years

INR 5.0 - 9.0 Lacs P.A.

Work from Office

Full Time

The Financial Project Analyst has wide ranging responsibilities of PFA related duties. Work with Project Management Team to accurately forecast future units and revenue. Manage the financial health of our projects, working closely with the project to team to accurate record all financial data, report financial data clearly to the Project team. Monitor the total project cash positions. Responsible for all the financial aspects of assigned projects Ongoing maintenance of the financial and operational data within the companies management information structure Creation and distribution of scheduled reports Complete month end responsibilities including revenue recognition and forecasts, variance analysis, profitability analysis, and any other reporting needs as required Support Proposals Contracts and Project Directors on the development of financial analysis for proposals Work closely with the Project Manager to provide on-going financial resource planning, management and analysis Supports the overall health of assigned projects Perform ad hoc financial analyses as requested by Project Managers and/or Department Heads

Project Finance Analyst

Pune

2 - 5 years

INR 5.0 - 9.0 Lacs P.A.

Work from Office

Full Time

The Financial Project Analyst has wide ranging responsibilities of PFA related duties. Work with Project Management Team to accurately forecast future units and revenue. Manage the financial health of our projects, working closely with the project to team to accurate record all financial data, report financial data clearly to the Project team. Monitor the total project cash positions. Responsible for all the financial aspects of assigned projects Ongoing maintenance of the financial and operational data within the companies management information structure Creation and distribution of scheduled reports Complete month end responsibilities including revenue recognition and forecasts, variance analysis, profitability analysis, and any other reporting needs as required Support Proposals Contracts and Project Directors on the development of financial analysis for proposals Work closely with the Project Manager to provide on-going financial resource planning, management and analysis Supports the overall health of assigned projects Perform ad hoc financial analyses as requested by Project Managers and/or Department Heads BA/BS degree in Business, Accounting, Finance, or equivalent education and experience. Demonstated relevant finance or accounting experience, project accounting/analysis a plus Pharmaceutical or CRO experience is preferable

Safety System Administrator

Pune

4 - 5 years

INR 13.0 - 15.0 Lacs P.A.

Work from Office

Full Time

Position Summary This role requires working as part of the Safety System Administrator Team performing database administration activities; supporting creation and upgrade of database instances; change control and data migration activities; first line user support and troubleshooting; and training users on databases. Principal Responsibilities The Safety System Administrator is primarily responsible for: Maintenance of database libraries Involvement in system validation activities Interrogating the database and generating outputs for internal and client use Training and providing database access to internal and client users Principle Functions For the Client (may include but is not limited to the following) Set up and maintenance of project specific database libraries including: o Products o Licenses o Studies o Reporting destinations Documenting and validating any change to the project specific database Support during legacy data transfer e.g., validation Supporting/providing guidance to the Project Manager / Client / Project Start Up Team during the development of project specific data handling guidelines (to ensure project specific guidelines are necessary and will not impact line listings and report generation) Prepare line listings and tabulations and other database outputs for use in aggregate reports, signal detection, reconciliation and other activities as required Provide case processing metrics required for invoicing (e.g., number of submissions, number of spontaneous vs initial cases processed) Provide database training to clients Providing and documenting client / internal team access upon receipt of an approved access request. For the Company (may include but is not limited to the following) Coordinate user access (including maintenance and revoking access) Maintain database procedures including core data handling conventions Provide database training and certification to PrimeVigilance users Provide user support Involvement in root cause investigation of database related deviations and ensure timely and complete documentation of resulting actions in line with Quality procedures Provide case processing quality and compliance metrics to the Quality Team Identify areas for improvement and address via training, clarifying changes to data handling guidelines, user guides etc. Execute business continuity periodic testing for database failure Ensure that existing software bugs, user requests, changes to regulatory requirements etc., are considered and appropriate changes are made and validated as required Support IT, database vendor and technical colleagues in troubleshooting and implementing software fixes and enhancements as required Other Supportive Responsibilities Assist PrimeVigilance senior management on an as needed basis. Potentially provide chargeable consulting / training activities to clients regarding Argus, and if required LSSMV. Qualifications Educated to degree standard Demonstrated work experience within Argus Safety Systems.

Safety System Administrator

Pune

4 - 5 years

INR 13.0 - 15.0 Lacs P.A.

Work from Office

Full Time

Position Summary This role requires working as part of the Safety System Administrator Team performing database administration activities; supporting creation and upgrade of database instances; change control and data migration activities; first line user support and troubleshooting; and training users on databases. Principal Responsibilities The Safety System Administrator is primarily responsible for: Maintenance of database libraries Involvement in system validation activities Interrogating the database and generating outputs for internal and client use Training and providing database access to internal and client users Principle Functions For the Client (may include but is not limited to the following) Set up and maintenance of project specific database libraries including: o Products o Licenses o Studies o Reporting destinations Documenting and validating any change to the project specific database Support during legacy data transfer e.g., validation Supporting/providing guidance to the Project Manager / Client / Project Start Up Team during the development of project specific data handling guidelines (to ensure project specific guidelines are necessary and will not impact line listings and report generation) Prepare line listings and tabulations and other database outputs for use in aggregate reports, signal detection, reconciliation and other activities as required Provide case processing metrics required for invoicing (e.g., number of submissions, number of spontaneous vs initial cases processed) Provide database training to clients Providing and documenting client / internal team access upon receipt of an approved access request. For the Company (may include but is not limited to the following) Coordinate user access (including maintenance and revoking access) Maintain database procedures including core data handling conventions Provide database training and certification to PrimeVigilance users Provide user support Involvement in root cause investigation of database related deviations and ensure timely and complete documentation of resulting actions in line with Quality procedures Provide case processing quality and compliance metrics to the Quality Team Identify areas for improvement and address via training, clarifying changes to data handling guidelines, user guides etc. Execute business continuity periodic testing for database failure Ensure that existing software bugs, user requests, changes to regulatory requirements etc., are considered and appropriate changes are made and validated as required Support IT, database vendor and technical colleagues in troubleshooting and implementing software fixes and enhancements as required Other Supportive Responsibilities Assist PrimeVigilance senior management on an as needed basis. Potentially provide chargeable consulting / training activities to clients regarding Argus, and if required LSSMV. Educated to degree standard Demonstrated work experience within Argus Safety Systems.

HR Analytics and Compensation Specialist

Pune

4 - 7 years

INR 6.0 - 9.0 Lacs P.A.

Work from Office

Full Time

Role and Responsibilities Compensation Conduct job evaluations and market pricing using salary surveys and benchmarking tools. Support the design, analysis, and administration of base salary structures, incentive programs, and merit planning processes. Maintain and update compensation databases, tools, and documentation. Collaborate with HR and business leaders to ensure internal equity and external competitiveness. Prepare compensation recommendations and participate in offer reviews. HR Analytics Support development and maintain HR dashboards and reports on key metrics (e.g., headcount, turnover, diversity, compensation trends). Analyze workforce data to identify trends, risks, and opportunities. Partner with HR and business teams to develop predictive models and provide insights for strategic workforce planning. Ensure data integrity across HR systems and identify areas for improvement. Translate complex data into clear narratives and actionable recommendations. Extensive experience in Compensation and HR analytics. Strong understanding of compensation principles and familiarity with salary survey methodologies (e.g., Mercer, Willis Towers Watson). Knowledge of company benefits management.

HR Analytics and Compensation Specialist

Pune

4 - 7 years

INR 10.0 - 14.0 Lacs P.A.

Work from Office

Full Time

Role and Responsibilities Compensation Conduct job evaluations and market pricing using salary surveys and benchmarking tools. Support the design, analysis, and administration of base salary structures, incentive programs, and merit planning processes. Maintain and update compensation databases, tools, and documentation. Collaborate with HR and business leaders to ensure internal equity and external competitiveness. Prepare compensation recommendations and participate in offer reviews. HR Analytics Support development and maintain HR dashboards and reports on key metrics (e. g. , headcount, turnover, diversity, compensation trends). Analyze workforce data to identify trends, risks, and opportunities. Partner with HR and business teams to develop predictive models and provide insights for strategic workforce planning. Ensure data integrity across HR systems and identify areas for improvement. Translate complex data into clear narratives and actionable recommendations.

Safety Systems Specialist

Pune

3 - 6 years

INR 6.0 - 9.0 Lacs P.A.

Work from Office

Full Time

The Safety Database Specialist will work as part of the PV Client Success and Safety Systems IT Team and will be responsible database related activities including data migrations requiring strong SQL developer skills, for providing technical expertise on pharmacovigilance systems, specifically the Argus Safety database, including planning and validation. The role is critical to pharmacovigilance to support and maintain the overall adverse event reporting system, electronic reporting to health authorities and ensuring compliance to the relevant regulatory requirements, policies and standards. Serves as subject matter expert for pharmacovigilance systems (Argus 8.x Oracle Cloud) and associated application integrations (eg OAS, Axway) Lead client data transfers (data imports and exports), SQL developer skills required, including prior experience in data migrations. Lead development, validation and implementation of standard and custom reports within company reporting tools. Query database to support inspections as required. Proactively identifies database requirements to maximize efficiency and quality of end user performance; takes initiative to investigate, develop and implement solutions. Proactively presents solutions to management. Manages the configuration/validation of the pharmacovigilance master tenant enterprise used for client enterprise creation. Lead project kick-off for client enterprise creation, validation and configuration. Gather functional and technical requirements. Provide configuration solutions to support client case processing and reporting. Leads safety database and associated systems upgrades/patches for the IT team, including project planning, testing and implementation. Manage and escalate system issues with the pharmacovigilance software vendors as needed. Assist with authoring pharmacovigilance system work instructions, standard operating procedures and associated forms. Maintains professional and technical knowledge through continuing education, such as workshops, reviewing professional publications, participating in professional organizations Accept project assignments as delegated by senior staff, as needed. Develops staff knowledge of the safety database through individual mentoring, classroom trainings, user workshops as needed Ensure compliance with relevant company policies and procedures. Bachelors degree in Information Technology or related experience Demonstrated knowledge and experience with pharmacovigilance systems in a pharmaceutical company, biotech or CRO (on premise or cloud-based solution). Demonst

Senior FP&A Analyst

Pune

3 - 6 years

INR 10.0 - 14.0 Lacs P.A.

Work from Office

Full Time

We are seeking a highly skilled Senior FP&A Analyst to join our dynamic finance team in Zagreb, Croatia. As a key member of our Financial Planning and Analysis department, you will play a crucial role in driving financial decision-making and supporting strategic initiatives across the organization. This role supports the Head of Group FP&A delivering consolidated budgets and forecasts for the Group along with the ownership of departmental budgeting, forecasting, and financial performance monitoring. Develop and maintain complex financial models to support budgeting, forecasting, and long-term planning processes. Consolidation and reporting of multi-divisional budgets and forecasts. Lead the budgeting and forecasting processes for assigned business units or regions. Analyse financial and operational data to identify trends, risks, and opportunities for performance improvement. Collaborate with cross-functional teams and stakeholders to gather inputs and understand business drivers. Perform variance analysis and provide actionable recommendations based on findings. Prepare and present comprehensive financial reports and dashboards for senior management and assist in the preparation of board presentations. Contribute to process improvement initiatives within the FP&A function and promote best practices in financial analysis, automate recurring tasks, and enhance data reliability. Ensure consistency and accuracy of financial data across systems and reports. Assist with integration activities for acquired companies to align and improve processes. Provide ad-hoc financial analysis and recommendations to support business initiatives. Bachelor s or Master s degree in Finance, Accounting, Economics, or a related field. Qualified member of an internationally recognised accounting body preferred (e.g. ACA, ACCA, CIMA, CPA). 4+ years of experience in Financial Planning & Analysis or a similar finance role Excellent analytical and problem-solving skills with a keen attention to detail Advanced Excel skills and proficiency in financial modelling techniques and PowerPoint for creating impactful presentations Strong communication skills with the ability to present complex financial information to non-financial stakeholders Experience with data analysis and visualization (FP&A / BI) tools (e.g. Anaplan, Board, PowerBI) is a strong plus Proficiency in ERP/Financial systems (e.g. SAP, Oracle, Sage) Ability to work effectively in a fast-paced, deadline-driven environment Proactive mindset, able to work on own initiative while also a collaborative team player. Strong time management and organizational skills, with the ability to handle multiple priorities. Fluency in English

Senior FP&A Analyst

Pune

3 - 6 years

INR 10.0 - 14.0 Lacs P.A.

Work from Office

Full Time

We are seeking a highly skilled Senior FP&A Analyst to join our dynamic finance team in Zagreb, Croatia. As a key member of our Financial Planning and Analysis department, you will play a crucial role in driving financial decision-making and supporting strategic initiatives across the organization. This role supports the Head of Group FP&A delivering consolidated budgets and forecasts for the Group along with the ownership of departmental budgeting, forecasting, and financial performance monitoring. Develop and maintain complex financial models to support budgeting, forecasting, and long-term planning processes. Consolidation and reporting of multi-divisional budgets and forecasts. Lead the budgeting and forecasting processes for assigned business units or regions. Analyse financial and operational data to identify trends, risks, and opportunities for performance improvement. Collaborate with cross-functional teams and stakeholders to gather inputs and understand business drivers. Perform variance analysis and provide actionable recommendations based on findings. Prepare and present comprehensive financial reports and dashboards for senior management and assist in the preparation of board presentations. Contribute to process improvement initiatives within the FP&A function and promote best practices in financial analysis, automate recurring tasks, and enhance data reliability. Ensure consistency and accuracy of financial data across systems and reports. Assist with integration activities for acquired companies to align and improve processes. Provide ad-hoc financial analysis and recommendations to support business initiatives.

Client Quality Assistant

Pune

2 - 3 years

INR 1.0 - 4.0 Lacs P.A.

Work from Office

Full Time

POSITION SUMMARY The Client Quality Assistant supports the Client Quality team with administrative tasks, including but not limited to tracking, document preparation, compliance assessment and project planning. The Client Quality Assistant supports the Client Quality team in ensuring that its activities are managed in compliance with global regulations, legislation and PrimeVigilance requirements. Drives quality and compliance by ensuring tracking of completion of key quality tasks for projects. Role and Responsibilities Key responsibilities include (but are not limited to): Document organisation Data retrieval and tracking for different purposes Conduct periodic training reconciliation and maintenance of training matrix Generate metrics and KPI assessment Prepare documents drafts and/or final lay out, as applicable Organise meetings and teleconferences Assist with the organisation of Client Quality department Perform other miscellaneous administrative tasks, as applicable Assistance with preparation of documents for audit/inspection requests Specified Additional Responsibilities Other administrative support as required. The Client Quality Assistant will support the PrimeVigilance Senior Leadership team and the Associate Director of Quality with assigned quality related projects and responsibilities. University graduate Advanced English (both spoken and written) Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint 2-3 yrs of experience in an administrative position involvi

Client Quality Assistant

Pune

2 - 3 years

INR 1.0 - 4.0 Lacs P.A.

Work from Office

Full Time

POSITION SUMMARY The Client Quality Assistant supports the Client Quality team with administrative tasks, including but not limited to tracking, document preparation, compliance assessment and project planning. The Client Quality Assistant supports the Client Quality team in ensuring that its activities are managed in compliance with global regulations, legislation and PrimeVigilance requirements. Drives quality and compliance by ensuring tracking of completion of key quality tasks for projects. Role and Responsibilities Key responsibilities include (but are not limited to): Document organisation Data retrieval and tracking for different purposes Conduct periodic training reconciliation and maintenance of training matrix Generate metrics and KPI assessment Prepare documents drafts and/or final lay out, as applicable Organise meetings and teleconferences Assist with the organisation of Client Quality department Perform other miscellaneous administrative tasks, as applicable Assistance with preparation of documents for audit/inspection requests Specified Additional Responsibilities Other administrative support as required. The Client Quality Assistant will support the PrimeVigilance Senior Leadership team and the Associate Director of Quality with assigned quality related projects and responsibilities.

Senior FP&A Analyst

Pune

4 - 6 years

INR 10.0 - 14.0 Lacs P.A.

Work from Office

Full Time

We are seeking a highly skilled Senior FP&A Analyst to join our dynamic finance team in Zagreb, Croatia. As a key member of our Financial Planning and Analysis department, you will play a crucial role in driving financial decision-making and supporting strategic initiatives across the organization. This role supports the Head of Group FP&A delivering consolidated budgets and forecasts for the Group along with the ownership of departmental budgeting, forecasting, and financial performance monitoring. Develop and maintain complex financial models to support budgeting, forecasting, and long-term planning processes. Consolidation and reporting of multi-divisional budgets and forecasts. Lead the budgeting and forecasting processes for assigned business units or regions. Analyse financial and operational data to identify trends, risks, and opportunities for performance improvement. Collaborate with cross-functional teams and stakeholders to gather inputs and understand business drivers. Perform variance analysis and provide actionable recommendations based on findings. Prepare and present comprehensive financial reports and dashboards for senior management and assist in the preparation of board presentations. Contribute to process improvement initiatives within the FP&A function and promote best practices in financial analysis, automate recurring tasks, and enhance data reliability. Ensure consistency and accuracy of financial data across systems and reports. Assist with integration activities for acquired companies to align and improve processes. Provide ad-hoc financial analysis and recommendations to support business initiatives. Bachelor s or Master s degree in Finance, Accounting, Economics, or a related field. Qualified member of an internationally recognised accounting body preferred (e.g. ACA, ACCA, CIMA, CPA). 4+ years of experience in Financial Plannin

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Primevigilance

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Pharmaceutical Services

Chicago

51-200 Employees

17 Jobs

cta

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