Planet Pharma
Manager Database Management & Analytics, CSPV
Planet Pharma, Basking Ridge, New Jersey, us, 07920
Job Description
Pay range: 40-70/hr *depending on experience • Assists in the implementation of project specific safety database configurations to meet the regulatory and business needs of the CSPV department. • Participates in system validation activities for the safety database and other safety-related systems. • Perform quality checks on configuration changes performed by the database service provider; Identify discrepancies between the request and the implementation and resolve or initiate their resolution. • Serve as a system administrator and perform configurations/master data updates like code lists, user access, reporting rules, product, and study, pilot tests with E2b partners in Development environment. • Work with CSPV Team(s) and DBMA team to complete the configuration forms and coordinate with the Safety system service provider to complete the needed configurations. • Maintain best practices for safety database configurations, customizations, aggregate reporting, data migration, data integration, E2B Gateway reporting set-up, interface with EDC and other new automation initiatives. • Assists with data management of safety-related PV systems. • Other duties as assigned.
Skills:
Experience supporting Oracle Argus Safety is required. Experience in safety reporting applications is required. Knowledge of PV reports would be helpful. Relational database(Argus Safety database) knowledge working with Oracle and SQL is required. General knowledge of Electronic Data Interchange (Axway B2Bi Interchange in particular a plus),Rave Safety Gateway, E2b Pilot Test with HA. General knowledge about the global safety reporting requirements and ICH E2B guidelines that govern the international reporting of adverse events on investigational and marketed products are preferred. Soft Skills: Candidate must have a professional, respectful, proactive demeanor. Able to communicate effectively and collaborate with different stakeholders and functional areas. Willing and able to provide support to other team members on projects; tasks; etc. Education: BS Computer Science/equivalent qualification with at least four (4) years of experience in Pharmacovigilance
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Pay range: 40-70/hr *depending on experience • Assists in the implementation of project specific safety database configurations to meet the regulatory and business needs of the CSPV department. • Participates in system validation activities for the safety database and other safety-related systems. • Perform quality checks on configuration changes performed by the database service provider; Identify discrepancies between the request and the implementation and resolve or initiate their resolution. • Serve as a system administrator and perform configurations/master data updates like code lists, user access, reporting rules, product, and study, pilot tests with E2b partners in Development environment. • Work with CSPV Team(s) and DBMA team to complete the configuration forms and coordinate with the Safety system service provider to complete the needed configurations. • Maintain best practices for safety database configurations, customizations, aggregate reporting, data migration, data integration, E2B Gateway reporting set-up, interface with EDC and other new automation initiatives. • Assists with data management of safety-related PV systems. • Other duties as assigned.
Skills:
Experience supporting Oracle Argus Safety is required. Experience in safety reporting applications is required. Knowledge of PV reports would be helpful. Relational database(Argus Safety database) knowledge working with Oracle and SQL is required. General knowledge of Electronic Data Interchange (Axway B2Bi Interchange in particular a plus),Rave Safety Gateway, E2b Pilot Test with HA. General knowledge about the global safety reporting requirements and ICH E2B guidelines that govern the international reporting of adverse events on investigational and marketed products are preferred. Soft Skills: Candidate must have a professional, respectful, proactive demeanor. Able to communicate effectively and collaborate with different stakeholders and functional areas. Willing and able to provide support to other team members on projects; tasks; etc. Education: BS Computer Science/equivalent qualification with at least four (4) years of experience in Pharmacovigilance
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.