Senior Manager, Pharmacovigilance page is loaded## Senior Manager, Pharmacovigilancelocations:
Remote - UStime type:
Full timeposted on:
Posted Todayjob requisition id:
R-103075The Senior Manager, Pharmacovigilance (PV) will be responsible for organization and managing of activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational compounds. Managing rapid and accurate data entry of AE reports into the safety database, coordinate follow-up as appropriate, maintain knowledge of SOP’s, guidance documents and the safety database under the direction of the Sr. Director, Head of Pharmacovigilance.**Essential Duties and Responsibilities**
• Responsible for receiving and processing AEs reported to American Regent, Inc. from any internal or external source of any product sold or distributed by the company and its divisions.
• Responsible for managing all PV operational activities.
• Interact with Medical Monitors, Project Managers, CRAs, Project Coordinators, external clinical site investigators, nurses, pharmacists, patients, and outside corporate manufacturing partners/distributors in order to receive, follow-up, and report AEs according to company SOPs.
• Work with individuals in each division and across various departments (regulatory affairs, clinical R&D, medical affairs, and quality assurance) interfaced with the Pharmacovigilance process.
• Coordinate investigations with Quality Assurance (QA) Department.
• Provide input into SOPs, updates, and modifications to initiate appropriate changes.
• Provide input on end-user’s issue with safety database.
• Review of study safety tables and listings.
• Supervise intake of AEs, making certain all required elements of a safety report are captured and that FDA guidelines are followed.
• Daily distribution of adverse event reports to drug safety associates.
•
Complies and distributes monthly reports.
• Oversees PV agreements (completion, revision, and resolution of partner issues, maintains spreadsheets/PV mailbox distribution list).
• Oversees, tracks, and participates in reconciliation process concerning marketed products that are the subject of safety data exchange agreements.
• Answer company queries pertaining to safety database.
• Oversees completion of monthly ad-hoc literature searches and yearly contract renewals.
• Oversees quarterly process for copying of PV files for forwarding to headquarters liaise with cross functional teams such as: QA/RA/Medical Affairs/Clinical R&D for resolution of any PV-related issues.
• Participates in quality initiatives and any associated deviations as needed.
• Tracks case processing metrics for monthly reports to senior management/leadership.
• Prepare SAE narratives and collaborate with CROs/vendors for SAE reconciliation.
• Review and verify AE and concomitant medication coding via MedDRA and WHO Drug coding internally and with CROs/vendors.
• Identify safety signal and coordinate with Medical Directors as to their interpretation.
• Perform any other tasks/duties as assigned by management.**Education Requirements and Qualifications**To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.• Healthcare Professional, Pharm.D.
or related Science Degree, BSN/RN/MSN required.
• Minimum of 8 years of experience in pharmacovigilance within pharmaceutical industry required.
• 3+ years of experience in a supervisory or managerial role required.
• Knowledge of FDA Regulations for industry governing reporting of adverse drug experiences required.
• Knowledge/experiences with handling of adverse drug experiences.
• Experience with internal and external audits is preferred.
• Excellent written and oral communication skills, strong analytical and problem-solving skills, strategic thinking, prudent decision making, proactive behavior, and the ability to collaborate effectively across multidisciplinary teams are essential.
• Strong technical aptitude with safety databases (e.g., Oracle ARGUS Safety Database) is required.
• Experience in authoring and reviewing internal documents such as Standard Operating Procedures, maintenance schedules and operating manuals.
• 10% travel required for team meetings and potential audits.**Expected Salary Range:****$165,000-185,000**## The salary range, is the
minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role.
Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.## ## American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide## range of other benefits.American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.Applicants have rights under Federal Employment Laws.* FMLA poster:* Know Your Rights: )* Employee Polygraph Protection Act:**Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:**·
All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.·
Our recruiting process includes multiple in person and/or video interviews and assessments.·
If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com
before responding.·
We never request payment, bank information, or personal financial details during our offer process.Your security is important to us, and we encourage you to stay vigilant when job searching.American Regent Inc. endeavors to make
accessible to any and all users.
If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities.
Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables.American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer.
For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide. #J-18808-Ljbffr
Remote - UStime type:
Full timeposted on:
Posted Todayjob requisition id:
R-103075The Senior Manager, Pharmacovigilance (PV) will be responsible for organization and managing of activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational compounds. Managing rapid and accurate data entry of AE reports into the safety database, coordinate follow-up as appropriate, maintain knowledge of SOP’s, guidance documents and the safety database under the direction of the Sr. Director, Head of Pharmacovigilance.**Essential Duties and Responsibilities**
• Responsible for receiving and processing AEs reported to American Regent, Inc. from any internal or external source of any product sold or distributed by the company and its divisions.
• Responsible for managing all PV operational activities.
• Interact with Medical Monitors, Project Managers, CRAs, Project Coordinators, external clinical site investigators, nurses, pharmacists, patients, and outside corporate manufacturing partners/distributors in order to receive, follow-up, and report AEs according to company SOPs.
• Work with individuals in each division and across various departments (regulatory affairs, clinical R&D, medical affairs, and quality assurance) interfaced with the Pharmacovigilance process.
• Coordinate investigations with Quality Assurance (QA) Department.
• Provide input into SOPs, updates, and modifications to initiate appropriate changes.
• Provide input on end-user’s issue with safety database.
• Review of study safety tables and listings.
• Supervise intake of AEs, making certain all required elements of a safety report are captured and that FDA guidelines are followed.
• Daily distribution of adverse event reports to drug safety associates.
•
Complies and distributes monthly reports.
• Oversees PV agreements (completion, revision, and resolution of partner issues, maintains spreadsheets/PV mailbox distribution list).
• Oversees, tracks, and participates in reconciliation process concerning marketed products that are the subject of safety data exchange agreements.
• Answer company queries pertaining to safety database.
• Oversees completion of monthly ad-hoc literature searches and yearly contract renewals.
• Oversees quarterly process for copying of PV files for forwarding to headquarters liaise with cross functional teams such as: QA/RA/Medical Affairs/Clinical R&D for resolution of any PV-related issues.
• Participates in quality initiatives and any associated deviations as needed.
• Tracks case processing metrics for monthly reports to senior management/leadership.
• Prepare SAE narratives and collaborate with CROs/vendors for SAE reconciliation.
• Review and verify AE and concomitant medication coding via MedDRA and WHO Drug coding internally and with CROs/vendors.
• Identify safety signal and coordinate with Medical Directors as to their interpretation.
• Perform any other tasks/duties as assigned by management.**Education Requirements and Qualifications**To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.• Healthcare Professional, Pharm.D.
or related Science Degree, BSN/RN/MSN required.
• Minimum of 8 years of experience in pharmacovigilance within pharmaceutical industry required.
• 3+ years of experience in a supervisory or managerial role required.
• Knowledge of FDA Regulations for industry governing reporting of adverse drug experiences required.
• Knowledge/experiences with handling of adverse drug experiences.
• Experience with internal and external audits is preferred.
• Excellent written and oral communication skills, strong analytical and problem-solving skills, strategic thinking, prudent decision making, proactive behavior, and the ability to collaborate effectively across multidisciplinary teams are essential.
• Strong technical aptitude with safety databases (e.g., Oracle ARGUS Safety Database) is required.
• Experience in authoring and reviewing internal documents such as Standard Operating Procedures, maintenance schedules and operating manuals.
• 10% travel required for team meetings and potential audits.**Expected Salary Range:****$165,000-185,000**## The salary range, is the
minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role.
Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.## ## American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide## range of other benefits.American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.Applicants have rights under Federal Employment Laws.* FMLA poster:* Know Your Rights: )* Employee Polygraph Protection Act:**Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:**·
All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.·
Our recruiting process includes multiple in person and/or video interviews and assessments.·
If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com
before responding.·
We never request payment, bank information, or personal financial details during our offer process.Your security is important to us, and we encourage you to stay vigilant when job searching.American Regent Inc. endeavors to make
accessible to any and all users.
If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities.
Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables.American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer.
For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide. #J-18808-Ljbffr