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HomeCompanies674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001Manager, Global Medical Safety

Manager, Global Medical Safety

674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001 · Lexington, MA, US, Lexington, MA · Remote · Active · $152,000–$160,000 / year · ADP Workforce Now Recruiting

Job facts

FieldValue
Company674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001
TitleManager, Global Medical Safety
Normalized title-
Department / team-
LocationLexington, MA, United States
Work modelRemote / Remote
Employment typeFull Time
Salary$152,000–$160,000 / year
Statusactive
ATS providerADP Workforce Now Recruiting
Posted / first seen2026-04-03 / 2026-05-31
Changed / last seen2026-06-06 / 2026-06-06

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PageWhat it containsOpen
Company jobsActive postings from 674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001.Open
Company breakdownsRole, location, ATS, and work model facets for this company.Open
ATS provider jobsActive postings observed through ADP Workforce Now Recruiting.Open
Provider filtered searchThe same provider as a filtered job collection.Open
City jobsActive postings in Lexington.Open
Work model jobsActive Remote postings.Open
Lifecycle eventsOpen, update, close, and reopen events for this posting.Open
Original postingCanonical source or apply URL captured from the ATS.Open

Linked records

Company674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001
Source4f2fb43e-6107-4f34-ab57-87d29ca5c68a
ATS providerADP Workforce Now Recruiting

Description

Reporting to the GVP, Global Medical Affairs, the Manager, Global Medical Safety will be responsible supporting GMS to assess, track, and document the ongoing benefit-risk profile of all marketed products and those in clinical development. This includes (but is not limited to) providing thorough sponsor oversight of delegated safety responsibilities outsourced to safety vendor, leading operations in development of aggregate reports (e.g., DSUR, PAER), providing new hire AE/SI training, and planning Internal Safety Review Committee (SRC) and Safety Review Team (SRT) meetings. This role interfaces across all levels of management and functional areas within Kiniksa to ensure timely management of all Global Medical Safety deliverables for both post-market and clinical stage products. This role is based in our Lexington, MA, office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote. Responsibilities (including, but not limited to): Interact across multiple functions, supporting GMS operational activities Lead the daily management, operational oversight, and execution of delegated operational global medical safety tasks for all Kiniksa programs Provide Sponsor oversight of delegated safety responsibilities outsourced to safety vendor, including the timely and accurate execution of the processes defined within the applicable Safety Management and Safety Reporting Plans Oversee deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs while collaborating with the QA department Develop AE/SI training materials and lead new hire training to ensure proper AE/SI reporting for both internal Kiniksa employees but also vendors acting on Kiniksa’s behalf Efficiently plan Internal Safety Review Committee (SRC) and Safety Review Team (SRT) meetings, ensuring both senior GMS team members and key stakeholders provide input from their respective areas of responsibility In collaboration with GMS team, provide technical and scientific support for safety surveillance and signal detection activities for assigned products Oversee coordination and contribution to the production of periodic and ad-hoc safety reporting for therapeutic team products, ensuring thorough cross-functional reviews and timely submissions of documents to regulatory agencies Support for investigational products and registration activities including effectively collaborating with stakeholders outside of GMS, and representing GMS department in cross-functional clinical programs and registrational activities Support the preparation and implementation of any GMS related internal or external audits or inspections Support the review and maintenance of all GMS SOPs and AE/SI Forms Qualifications: Requires an advanced life science degree, (ie PharmD, PhD) or in a related science, with a minimum of 3 years of experience within the pharmaceutical industry or related field; minimum of 2 years of medical pharmacovigilance experience preferred. Ability to handle multiple demands in a fast-paced environment. Must be able to exercise appropriate judgment, as necessary. Requires a high level of initiative and independence. Excellent project management skills, attention to detail Highly self-motivated and able to handle multiple tasks in a timely fashion Familiarity of PC-based applications, including Microsoft Word, Excel, PowerPoint, and Outlook Analytical, solutions-oriented, negotiation, and strategic-thinking skills Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors Ability to synthesize and communicate (verbally and in writing) safety data and clinical/pharmaceutical information Working knowledge of domestic and international regulatory safety reporting requirements for investigational and marketed products, including FDA/ICH guidance’s related to pharmacovigilance (e.g., E2B) and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety Experience working with all levels of management and consulting with key business stakeholders Salary is commensurate with experience The pay range for this position is $152,000 - $160,000. Compensation is subject to change commensurate with industry standards and the candidate’s relevant experience and qualifications. Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Full job record

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Org ID952c9fe5-daa7-4a0c-b3f8-5d560f99a753
Source ID4f2fb43e-6107-4f34-ab57-87d29ca5c68a
Board ID4f2fb43e-6107-4f34-ab57-87d29ca5c68a
Provideradp_workforcenow
Provider Job Key609621
TitleManager, Global Medical Safety
Normalized Title
Statusactive
Activeyes
Location TextLexington, MA, US, Lexington, MA
Department
Team
Employment Typefull_time
Workplace Typeremote
Remote Policyremote
CountryUnited States
RegionMA
CityLexington
Salary Raw152000.00 To 160000.00 (USD) Annually
Salary Min152,000
Salary Max160,000
Salary CurrencyUSD
Salary Periodyear
Source URLhttps://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=674a37b7-4b6a-4f38-a5e8-50a609cdab78&ccId=19000101_000001&lang=en_US&type=JS&jobId=609621&jwId=9201829398927_1
Apply URLhttps://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=674a37b7-4b6a-4f38-a5e8-50a609cdab78&ccId=19000101_000001&lang=en_US&type=JS&jobId=609621&jwId=9201829398927_1
First Seen At2026-05-31 18:30:04Z
Last Seen At2026-06-06 11:50:59Z
Last Checked At2026-06-06 11:50:59Z
Last Changed At2026-06-06 11:50:59Z
Inactive At
Source Posted At2026-04-03 18:01:00Z
Source Updated At
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    "requisitionDescription": "<div><div><div><div><p data-pasted=\"true\"><span style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Reporting to the GVP, Global Medical Affairs, the Manager, Global Medical Safety will be responsible supporting GMS to assess, track, and document the ongoing benefit-risk profile of all marketed products and those in clinical development. This includes (but is not limited to) providing thorough sponsor oversight of delegated safety responsibilities outsourced to safety vendor, leading operations in development of aggregate reports (e.g., DSUR, PAER), providing new hire AE/SI training, and planning Internal Safety Review Committee (SRC) and Safety Review Team (SRT) meetings. This role interfaces across all levels of management and functional areas within Kiniksa to ensure timely management of all Global Medical Safety deliverables for both post-market and clinical stage products.</span></p><p><span style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">This role is based in our Lexington, MA, office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.&nbsp;</span></p><p><span style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\"><strong>Responsibilities (including, but not limited to):</strong></span></p><ul><li data-pasted=\"true\" style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Interact across multiple functions, supporting GMS operational activities</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Lead the daily management, operational oversight, and execution of delegated operational global medical safety tasks for all Kiniksa programs</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Provide Sponsor oversight of delegated safety responsibilities outsourced to safety vendor, including the timely and accurate execution of the processes defined within the applicable Safety Management and Safety Reporting Plans</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Oversee deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs while collaborating with the QA department</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Develop AE/SI training materials and lead new hire training to ensure proper AE/SI reporting for both internal Kiniksa employees but also vendors acting on Kiniksa&rsquo;s behalf</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Efficiently plan Internal Safety Review Committee (SRC) and Safety Review Team (SRT) meetings, ensuring both senior GMS team members and key stakeholders provide input from their respective areas of responsibility</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">In collaboration with GMS team, provide technical and scientific support for safety surveillance and signal detection activities for assigned products</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Oversee coordination and contribution to the production of periodic and ad-hoc safety reporting for therapeutic team products, ensuring thorough cross-functional reviews and timely submissions of documents to regulatory agencies</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Support for investigational products and registration activities including effectively collaborating with stakeholders outside of GMS, and representing GMS department in cross-functional clinical programs and registrational activities</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Support the preparation and implementation of any GMS related internal or external audits or inspections</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Support the review and maintenance of all GMS SOPs and AE/SI Forms</li></ul><p data-pasted=\"true\"><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong><span style=\"color: rgb(0, 0, 0);\">Qualifications:</span></strong></span></p><ul><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Requires an advanced life science degree, (ie PharmD, PhD) or in a related science, with a minimum of 3 years of experience within the pharmaceutical industry or related field; minimum of 2 years of medical pharmacovigilance experience preferred.</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Ability to handle multiple demands in a fast-paced environment. Must be able to exercise appropriate judgment, as necessary. Requires a high level of initiative and independence.</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Excellent project management skills, attention to detail</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Highly self-motivated and able to handle multiple tasks in a timely fashion</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Familiarity of PC-based applications, including Microsoft Word, Excel, PowerPoint, and Outlook</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Analytical, solutions-oriented, negotiation, and strategic-thinking skills</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Ability to synthesize and communicate (verbally and in writing) safety data and clinical/pharmaceutical information</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Working knowledge of domestic and international regulatory safety reporting requirements for investigational and marketed products, including FDA/ICH guidance&rsquo;s related to pharmacovigilance (e.g., E2B) and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety</li><li style=\"color: rgb(0, 0, 0); font-size: 14px; font-family: arial, sans-serif;\">Experience working with all levels of management and consulting with key business stakeholders</li><li style=\"font-size: 14px; font-family: arial, sans-serif;\"><span style=\"margin: 0px; padding: 0px; color: rgb(0, 0, 0); line-height: 19px;\"><span style=\"margin: 0px; padding: 0px;\">Salary is commensurate with experience</span></span></li></ul><p style=\"margin: 0px 0px auto;padding: 0px;font-weight: normal;font-style: normal;vertical-align: baseline;background-color: rgb(255, 255, 255);color: windowtext;text-align: left;text-indent: 0px;\"><br data-pasted=\"true\"><span style=\"font-size:inherit;\">The pay range for this position is $152,000 - $160,000. Compensation is subject to change commensurate with industry standards and the candidate&rsquo;s relevant experience and qualifications.&nbsp;</span></p><p style=\"margin: 0px 0px auto;padding: 0px;font-weight: normal;font-style: normal;vertical-align: baseline;background-color: rgb(255, 255, 255);color: windowtext;text-align: left;text-indent: 0px;\"><br></p><p style=\"margin: 0px 0px auto;padding: 0px;font-weight: normal;font-style: normal;vertical-align: baseline;background-color: rgb(255, 255, 255);color: windowtext;text-align: left;text-indent: 0px;\"><span style=\"margin: 0px; padding: 0px; color: rgb(0, 0, 0); font-size: 14px; line-height: 19px; font-family: arial, sans-serif;\"><span style=\"margin: 0px; padding: 0px;\">Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</span></span></p></div></div></div></div>\n",
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