Pharmacovigilance Specialist
Pharmacovigilance Specialist
Posted on :
17-01-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Description
Job title: PV Project Lead
Reports to: Head of PV function
Job purpose
The role involves managing the project delivery and maintaining service quality for safety information management of pharmaceuticals and medical devices (clinical trials Literature and postmarketing). As the primary client contact the Project Manager oversees the operational team to ensure seamless and transparent service delivery. Additionally the role strengthens partnerships with clients and collaborates with global teams and partner organizations to expand and enhance client relationships.
Duties and responsibilities
Project Deliverables Management:
o Lead daytoday client interactions and oversee project plans timelines deliverables scope quality and profitability.
o Perform financial management tasks including financial system updates revenue recognition invoicing budget reviews financial analyses and handling change orders.
Performance Oversight:
o Monitor KPIs (revenue cost profit) and ensure financial performance targets are met.
Risk Management:
o Identify potential risks at project initiation based on SOPs and best practices and implement risk mitigation strategies during execution.
Provides expertise training and project management support to the Safety Reporting System (SRS) user community (internal & external) in gathering and documenting user requirements database setup testing maintenance and database migrations.
Work closely with vendors to provide full system support capabilities.
Keep management appraised of any potential/actual study or staffing issues and assist with developing solutions
Assist with maintenance of project budgets and oversight by identifying out of scope activities
Serve as a mentor and role model for Systems staff
Assist upper management with resourcing and business development activities
Manage PV projects including Sponsor liaison and management of timelines and budgets as appropriate
Ensure audit readiness and PV Systems representation at audits
Ensure all assigned project and departmental activities are completed in accordance with company standards regulatory requirements and contractual obligations to Sponsors
Working closely with the PV QA team to bring greater efficiencies
Facilitates the accurate configuration of Argus databases through working with users and the Safety Systems Team to ensure that requirements are documented correctly.
Work with colleagues management and other departments as necessary to implement change / process and systems improvement.
Complete all departmental project activities accurately and in accordance with SOPs Project Specific Procedures regulatory requirements and Sponsors processes.
Serve as the main point of contact for the customer for the lifecycle of assigned systems
Stakeholder Meetings: Lead internal and external meetings to update project status discuss strategies and ensure alignment with objectives.
Stakeholder Coordination:Collaborate effectively with domestic and international stakeholders to ensure smooth project execution.
Staying uptodate with the latest developments in drug safety including new regulations and guidelines to ensure that safety evaluations are conducted in accordance with the latest standards.
Participating in ongoing safety surveillance programs to monitor the safety of drugs once they are on the market.
o Lead daytoday client interactions and oversee project plans timelines deliverables scope quality and profitability.
o Perform financial management tasks including financial system updates revenue recognition invoicing budget reviews financial analyses and handling change orders.
Performance Oversight:
o Monitor KPIs (revenue cost profit) and ensure financial performance targets are met.
Risk Management:
o Identify potential risks at project initiation based on SOPs and best practices and implement risk mitigation strategies during execution.
Provides expertise training and project management support to the Safety Reporting System (SRS) user community (internal & external) in gathering and documenting user requirements database setup testing maintenance and database migrations.
Work closely with vendors to provide full system support capabilities.
Keep management appraised of any potential/actual study or staffing issues and assist with developing solutions
Assist with maintenance of project budgets and oversight by identifying out of scope activities
Serve as a mentor and role model for Systems staff
Assist upper management with resourcing and business development activities
Manage PV projects including Sponsor liaison and management of timelines and budgets as appropriate
Ensure audit readiness and PV Systems representation at audits
Ensure all assigned project and departmental activities are completed in accordance with company standards regulatory requirements and contractual obligations to Sponsors
Working closely with the PV QA team to bring greater efficiencies
Facilitates the accurate configuration of Argus databases through working with users and the Safety Systems Team to ensure that requirements are documented correctly.
Work with colleagues management and other departments as necessary to implement change / process and systems improvement.
Complete all departmental project activities accurately and in accordance with SOPs Project Specific Procedures regulatory requirements and Sponsors processes.
Serve as the main point of contact for the customer for the lifecycle of assigned systems
Stakeholder Meetings: Lead internal and external meetings to update project status discuss strategies and ensure alignment with objectives.
Stakeholder Coordination:Collaborate effectively with domestic and international stakeholders to ensure smooth project execution.
Staying uptodate with the latest developments in drug safety including new regulations and guidelines to ensure that safety evaluations are conducted in accordance with the latest standards.
Participating in ongoing safety surveillance programs to monitor the safety of drugs once they are on the market.
Education & Experience
Bachelors or Masters degree in PharmaMedical or Dental Sciences Other Life Sciences Streams
Previous experience that provides the knowledge skills and abilities to perform the job (7 years).
Experience working in the pharmaceutical/CRO industry preferred. 3 years previous experience in medical review
Previous experience using a Pharmacovigilance Database
Knowledge Skills and Abilities
Skills:
o Causality Assessment Clinical SAS Programming Communication Skills CPC Certified GCP guidelines ICD10 CM Codes CPTCodes HCPCS Codes ICD10 CM CPT HCPCS Coding ICH guidelines ICSR Case Processing Interpersonal Skill Labelling Assessment MedDRA Coding Medical Billing Medical Coding Medical Terminology Narrative Writing Research & Development Technical Skill Triage of ICSRs WHO DD Coding
Knowledge of International and US Regulatory Requirements
Ability to work effectively in high paced and team environment
Strong organizational written and verbal communication skills
Excellent technical data interpretation skills
Strong understanding of Medical Sciences
Excellent interpersonal skills including problem solving
Strong presentation skills
Languages: Businesslevel proficiency in both Japanese and English (reading writing and speaking).
Leadership and Team Management: Strong team management leadership and problemsolving skills.
Project Management Skills: Ability to manage multiple projects and prioritize tasks effectively.
Decisionmaking negotiation and problemresolution abilities.
Strategic business acumen financial analysis skills tactical planning and budgeting expertise.
Interpersonal Skills: Proven ability to establish and maintain effective working relationships with colleagues managers and clients. Excellent communication and negotiation skills within a matrix organization to achieve results.
Significant knowledge of global regional national and other document development guidelines
Flexible Adaptive Ability to work under pressure and provide quality outputs within tight timelines
Other requirements
As may be required from time to time the incumbent may be required to working slots catering to different time zones
Job Type
Full Time. Work from Office
Full Time. Work from Office
Location
Gurgaon Haryana (INDIA)
Gurgaon Haryana (INDIA)
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
