Associate Manager - Safety Data and Systems
About the job
- A Bachelor's degree or country equivalent in life sciences, Information Technology, or another relevant field.
- At least 7 years of relevant experience in IT, safety, clinical research, or pharmacovigilance, including at least 3 years of experience with safety database systems such as Oracle Argus Safety or ArisG and workflow management.
- Solid knowledge of global pharmacovigilance requirements and practices across Europe, the United States, and Asia-Pacific.
- Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents.
- Proficiency with current office applications and Microsoft Excel.
- Proficiency in safety database systems such as Oracle Argus Safety and knowledge of related pharmacovigilance technical systems, including E2B gateways and safety signal detection tools.
- Proficiency with electronic safety and pharmacovigilance systems used for data visualization, analysis, and dashboards.
- Robust understanding of end-to-end clinical and post-marketing safety event collection and reporting, workflow-based case processing, and the Medical Dictionary for Regulatory Activities.
- Solid understanding of aggregate safety report development and submission, including Development Safety Update Reports and Periodic Safety Update Reports.
- Solid understanding of quality management processes, metrics, and key performance indicators.
- Fluent written and spoken English communication.
- Ability to work independently with minimal oversight, prioritize effectively, complete multiple complex deliverables within tight timelines, and function effectively in a team environment.
- Lead deliverables for GPS Safety Data Management and Safety System Maintenance activities.
- Provide high-quality data outputs for safety signal management, risk management, and safety evidence generation.
- Collaborate with argenx functions and applicable vendors to support GPS Safety Data and Systems operations.
- Manage and monitor applicable GPS mailboxes, including unblinded data.
- Serve as the key technical resource for configuring, maintaining, and administering the Oracle Argus Safety system.
- Support day-to-day operation and troubleshooting of the Argus Safety application to ensure reliable and compliant drug safety case processing.
- Assist in system validation, testing, and deployment of Argus Safety system updates, workflows, and business rules.
- Generate, validate, and customize safety reports and analytics using Argus reporting tools and associated business intelligence platforms.
- Collaborate with pharmacovigilance, clinical, and regulatory teams to align safety data management with global regulatory standards, including FDA, EMA, PMDA, and ICH.
- Participate in change-management processes to enhance Argus Safety system workflows and system integrations.
- Contribute to audit-readiness activities, including system inspections, validation reports, and compliance documentation.
- Collaborate with the internal systems team, Business Information Systems, and safety vendors on safety database configuration issues.
- Generate and perform quality control of aggregate reports and line listings.
- Initiate and contribute to procedural documents, including Safety Management Plans, standard operating procedures, work instructions, job aids, forms, and templates.
- Collaborate with argenx functions such as Medical Information, Data Management, Business Information Systems, and Quantitative Science on pharmacovigilance technical setup and operation.
- Keep up to date on applicable regulatory and pharmacovigilance technology guidelines and share relevant information within GPS and argenx.
- Participate in training related to safety data management.
- Review processes and tools proactively and suggest improvements and efficiency gains.
- Complete additional tasks and projects assigned by the line manager or Head of GPS Operations.
- Experience with SQL.
About the company
argenx develops and markets antibody-based therapies for severe autoimmune diseases. Its medicines work by modulating the immune system through engineered antibodies, notably efgartigimod (VYVGART for generalized myasthenia gravis and VYVGART Hytrulo for CIDP) that influence FcRn pathways. The company differentiates itself through antibody engineering capabilities and a co-creation model with academic and industry partners, plus a pipeline focused on FcRn-, complement-, and target-directed programs across autoimmune indications. Its goal is to provide effective antibody medicines that improve patient outcomes and expand global access through its development and commercial footprint.
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
Amsterdam, Netherlands
Founded
2008
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Simplify's Take
What believers are saying
- May 8, 2026 FDA approval opened VYVGART to all adult gMG serotypes.
- August 17, 2026 ALKIVIA met primary endpoint in autoimmune myositis, adding a multibillion-dollar indication.
- September 29, 2026 AANEM data extended VYVGART into ocular MG and longer-duration CIDP use.
What critics are saying
- UCB's RYSTIGGO and J&J's nipocalimab attack the same FcRn market by 2027.
- VYVGART concentration remains extreme; one franchise drove $2.8 billion first-half 2026 sales.
- If ALKIVIA or upcoming myositis filings disappoint, argenx loses its next blockbuster expansion.
What makes argenx unique
- VYVGART is first-and-only approved for all adult gMG serotypes after May 8, 2026.
- argenx scaled $1.5 billion Q2 2026 product sales with 60% year-over-year growth.
- August 27, 2026 Forte acquisition added FB102, broadening the immunology pipeline.
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Growth & Insights and Company News
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↑ 0%Argenx, a biopharmaceutical company with a market capitalisation near $60 billion, has caught the attention of Wall Street analysts. Ten analysts predict the biotech stock will reach at least $1,200 over the next 12 months, up from around $919 as of 2 October 2026. Wells Fargo and UBS set the highest price targets at $1,415 and $1,400 respectively, representing potential gains exceeding 50%. The average price target amongst 21 analysts stands at approximately $1,182, suggesting 29% upside. All but one analyst recommends buying the stock. Argenx's optimism stems from strong performance, delivering $1.5 billion in global product net sales last quarter, up 60% year over year. Its flagship drugs Vyvgart and Vyvgart Hytrulo drive growth, with additional approvals for autoimmune diseases potentially forthcoming.
argenx to Present New VYVGART Data in MG and CIDP, Plus Pipeline Results, at AANEM 2026. 09/30/2026 Key Takeaways * argenx will present data on its portfolio and pipeline at the AANEM Annual Meeting and the MGFA Scientific Session, September 29 to October 2 in Orlando, Florida, including four oral presentations and dozens of posters. * New VYVGART (efgartigimod) results include deepening improvement in ocular myasthenia gravis (MG), sustained one-year efficacy in anti-AChR antibody-negative generalized MG (gMG), real-world data on earlier treatment, and long-term and switch data in chronic inflammatory demyelinating polyneuropathy (CIDP). * argenx will also present Phase 2 empasiprubart data in multifocal motor neuropathy (MMN) and Phase 1b adimanebart data in DOK7 congenital myasthenic syndrome (CMS). argenx, an Amsterdam-based immunology company, announced it will present clinical, long-term, and real-world data for VYVGART (intravenous efgartigimod alfa-fcab) and VYVGART Hytrulo (subcutaneous efgartigimod alfa and hyaluronidase-qvfc), along with results for two pipeline candidates. Chief Medical Officer Luc Truyen, M.D., Ph.D., said the data show how far the evidence for VYVGART reaches, across years of treatment and into patient populations historically left out of clinical trials. In MG, the company will present three sets of findings: * Ocular MG. In the Phase 3 ADAPT OCULUS study, patient-reported ocular scores on the Myasthenia Gravis Impairment Index (MGII) improved further after two VYVGART cycles beyond the placebo-controlled period. Scores went from -4.5 to -6.8 points in patients with anti-AChR antibodies and from -2.7 to -4.5 points in triple-seronegative patients. The company says the results build on evidence for VYVGART's potential as the first targeted treatment for ocular MG.
Argenx stock has gained roughly 14% year-to-date, with Wall Street analysts projecting a potential 23% upside over the next 12 months. The biotech company has delivered 18 consecutive quarters of revenue growth. In Q2 2026, Argenx's global product net sales surged 60% year over year to $1.5 billion, with a 17% quarter-over-quarter increase. The Vyvgart franchise, treating chronic autoimmune disorders, drives growth following May 2026 FDA approval making it the first treatment for all serotypes of adults with generalised myasthenia gravis. Approximately 24,000 US patients receive treatment for chronic inflammatory demyelinating polyneuropathy, with half not well-managed on current therapy. Argenx reported positive Phase 3 results for Vyvgart in ocular myasthenia gravis earlier this year, with regulatory filing underway.
Compliance Jobs Report: sept. 18. By Matt Kelly | September 18, 2026 This week the Compliance Jobs Report has a new top ethics and compliance dog at Uber, plus other hiring news at ATR, Argenx, Airbus, Bank of America, and several other places. Promotions to note at Kohler, RTX, Emerson, and more; job leads are in engineering, higher education, and banking. Plus its Meme of the Week! Radical Compliance gather the Jobs Report news items from LinkedIn, press releases, and wherever else Radical Compliance can find tips - and thank you to everyone who sends them in, you make the Jobs Report possible! If you have any gossip to share (even confidentially) email me at [email protected] or find me on LinkedIn. Compliance Jobs. This week Radical Compliance start with big news at Uber: the company has hired Matt Olsen as chief ethics, compliance, and security officer. Olsen comes to the ride-share giant from law firm Wilmer Hale, where he spent the last 18 months as chair of the firm's national security and government contracts practice; prior to that, he was assistant AG for national security at the Justice Department. Olson is the first permanent CCO at Uber since Scott Schools left the company in late 2024 to be head of compliance at OpenAI. (Technically, Heather Childs held the chief ethics and compliance role before Olsen; but she had been chief trust and security officer first and then Uber tacked the CCO title onto her portfolio before she left the company earlier this summer.) Michael Oren has joined Airbus as director of ethics and compliance. Oren previously worked at Lowe's Cos. as a director of compliance until earlier this spring. By the way, Radical Compliance is hearing still more rumors of departures within Centene Corp.'s compliance function, as first noted in last week's Jobs Report. Again, if you want to feed Radical Compliance more information, drop me a line at [email protected]! OneAscent, a financial services business in Birmingham, Ala., that caters to faith-based investment advisers, has named Monica Stoudemire chief compliance officer. Prior to OneAscent, Stoudemire was chief compliance officer at Bridgeworth Wealth Management, a Birmingham-based registered investment adviser with more than $2 billion in client assets. Ivana Popratnik has been hired at financial services firm Oanda as chief compliance officer. Popratnik comes to Oanda after four years at TastyFx, where she most recently had been compliance officer. Memorial Healthcare System in Hollywood, Fla., has hired Daniel Villavisanis as director of corporate compliance. Villavisanis comes to Memorial after not quite three years at United Surgical Partners International, where he had been a compliance officer. Bolton Clarke, an assisted-living healthcare system in Australia, has tapped Stephanie Brown as head of internal audit. Brown previously worked as director of audit, risk, and compliance at the Department of Natural Resources in Queensland. Michael Grace has delivered himself to shipping and logistics firm Freight Flex, where he is chief compliance officer. Grace comes to Freight Flex from Highway, a business that helps track the identities of freight carriers, where he had been vice president of customer risk management. Brian Stachow has joined Argenx as as associate director of ethics and compliance training. Stachow comes to the mid-sized biotech firm from Agilent Technologies, where he had been an instructional designer. Altruist, a "tech-forward wealth platform" for independent financial advisers, has hired Nina Karbaum as director of compliance. Karbaum formerly worked at FINRA (the regulator for broker-dealers) where she had been a regulatory examiner until August. French aircraft manufacturer ATR has hired Stefano Spanò as chief compliance officer. Spanò joins ATR, a maker of turbo-prop jets for regional travel, after 11 years at Italian defense contractor Leonardo, where he had most recently been a senior trade compliance officer. Emirates NBD, one of the larger banks in the Middle East, has tapped Mohammed Samir as chief audit executive for the bank's Egypt operations. Samir comes to Emirates from Abu Dhabi Commercial Bank, where he had also been chief audit executive since. 2020. Dhiman Biswas has a new job as senior manager of compliance analytics at Bank of America. Biswas previously worked at Collabera as a project management consultant and prior to that was a business analytics specialist at MassMutual. Curia, a contract manufacturing business in the pharmaceutical sector, has hired Vicki Jackson as quality compliance manager. Jackson was last seen at Otsuka ICU Medical, where she had been an audit manager. And Seth Herrington has joined Map Transit, a freight forwarding business in Florida, as compliance coordinator. Herrington had previously been in the U.S. Marine Corps working on regulatory compliance issues for the Office of the Inspector General and just wrapped up a college degree at the University of Central Florida. Welcome to the profession, Mr. Herrington. Moving up the ladder. Akuvo, a maker of AI-powered software for collections and credit risk management, has promoted Molly DeMarcus from senior launch adviser to model governance compliance analyst (a title I suspect Radical Compliance'll see more often in its AI-enhanced future). Bath and kitchen products manufacturer Kohler has promoted Dan Rieland from manager of codes and standards to senior manager for product regulatory compliance. Katelyn Weese has moved up the ladder at defense contractor RTX Corp. Weese had worked for several years in various roles supporting the RTX board; now she's associate director of the global ethics and compliance program. Electric equipment manufacturer Emerson has promoted Michael Gilchrist from senior associate general counsel to vice president for regulatory compliance. Rody Lingiah has a new role within the Capgemini empire. He had been an export control officer for the firm's Sogeti subsidiary; now he's export control manager for Capgemini Engineering. Siemens Healthineers has promoted Ievgeniia Vasylchenko to chief compliance officer for central and eastern Europe. Vasylchenko had previously ran compliance for Siemens' lab diagnostics business in the region and was regional compliance officer for Ukraine. Open req orders. Engineering and professional services giant KBR is seeking a staff attorney for its anti-corruption and business integrity team. Job can be based in either Houston or Arlington, Va.; salary range not provided. Looks like KBR is hiring for a few other ethics and compliance roles, too. Tufts University is looking for a privacy program manager. Job is based in Medford, Mass., just outside Boston. Salary range is $108,000 to $162,000. MVB Bank is hiring a director of fair banking compliance and enterprise compliance advisory. The job can be remote, although MVB's headquarters are in West Virginia. No salary range provided. #NotCool Compliance Meme of the Week. That's all for this week's report. As always, if you have a tip or want to brag about your new job, promotion, career milestone, or anything else, email me at [email protected] or find me on LinkedIn. I'm always happy to give credit to the many hard-working people here in its corner of the business universe. Posted in News
argenx SE, a global immunology innovation company, has appointed Thomas M. Brakel and Khurem Farooq as non-executive directors to its Board of Directors. The appointments were announced following the company's Extraordinary General Meeting of Shareholders. Tim Van Hauwermeiren, chairperson of the board, said the new directors bring valuable leadership and expertise as argenx works towards its Vision 2030 goals. The company develops antibody-based medicines for autoimmune diseases and has commercialised the first approved neonatal Fc receptor blocker. Voting results and related documents from the shareholders' meeting are available on the argenx website. The company partners with academic researchers to translate immunology research into treatments for diseases with high unmet medical needs.