Remote PhysicianJobs
.org
Talent CollectiveJob Alerts

Medical Director, Ophthalmology - Safety and Benefit Risk Management

LocationRemote-USA
Salary
Remote🌴Remote allowed
First listedIn the last 6 days
Company Info👉 See Apellis Pharmaceuticals company tax, EIN & IRS information

Job Description

Position Summary:

The Medical Director, Ophthalmology - Safety and Benefit Risk (SABR) is responsible for all aspects of patient safety including single case and aggregate safety monitoring, safety reporting, benefit-risk assessment, risk management planning and strategy, execution of certain post-marketing commitments, and compliance with global regulatory requirements. The Medical Director is a critical part of this function providing safety and benefit risk management strategies across Apellis products and programs. They are the Safety Medical lead for all safety activities. Reporting to the Head of Medical Safety Science, the Medical Director will serve as the Medical Safety Lead for Apellis ophthalmology products.

Key Responsibilities Include:

  • Collaborate with relevant functions, the Medical Director will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit risk of their products.
  • The Medical Director will communicate potential and known risks, when appropriate, to Chief Medical Officer (CMO), Pharmacovigilance team including the Qualified Person for Pharmacovigilance (EU QPPV) as applicable, Senior Management, Health Authorities (HA), prescribers and/or patients.
  • Lead safety activities and benefit-risk strategies for assigned compounds and chair the product safety signal management (SSMT) team meeting.
  • Perform ongoing safety data review and analysis for products in the therapeutic areas of ophthalmology.
  • Lead team in evaluation of signals emerging from any data source through case-series review, document analysis, safety topic reviews or other means of communication.
  • Provide input to R&D publication strategy, publication plan, and ensure safety input to publications and presentations.
  • Lead medical safety development and execution of benefit-risk management strategies for assigned products.
  • Provide safety input to clinical development plans, study protocols, amendments, investigator brochure, statistical analysis plans, informed consent, clinical study reports, responses to queries from health authorities or ECs/IRBs.
  • Provide medical safety, benefit-risk input and approve periodic safety update reports, product renewal submissions, post marketing study documents and reports, and responses to health authority queries.
  • Lead or actively participate in department-wide initiatives.

Education, Registration & Certification:

  • Healthcare Professional (HCP) or Physician (MD or equivalent) with a minimum of 2 years of pharmacovigilance experience or other relevant experience (e.g. Clinical research, Medical Affairs)

Experience:

  • Experience in ophthalmology, experience in retinal disease is a plus.
  • Demonstrated experience with medical assessments and medical monitoring activities.
  • Experience with ophthalmology clinical development including risk/benefit analysis and safety assessment.
  • Able to plan work to meet deadlines and effectively handle multiple priorities.
  • Strong analytical, problem solving and scientific writing and communication skills.

Physical Demands and Work Environment:

  • This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

  • Up to 20% travel expected.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more! Visit https://apellis.com/careers/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

;

Apply to Job

👉 Please mention that you found the job on RemotePhysicianJobs.org, this helps us get more remote physician jobs & companies listed here, thanks!

Get a referral to Apellis Pharmaceuticals

If possible, try to get a warm intro/referral to Apellis Pharmaceuticals before applying! Do a LinkedIn search to see who you may know at the company. See this LinkedIn from Steven for more details on this tactic.

More jobs from Apellis Pharmaceuticals

Get job alerts & stay up to date via our newsletter:

Remote physician jobs jobs by role

Cardiology jobsDermatology jobsMedical Director jobsMedical Science Liaison jobsOB-GYN jobsPart-Time jobsPediatrics jobsPhysician jobsPrimary Care jobsPsychiatry jobsUrgent Care jobsUtilization Management jobs

Remote physician jobs jobs by organization

Johnson & Johnson jobsJourney Clinical jobsJustAnswer jobsK Health jobsKEPRO jobsKMG Medical Group jobsKarius jobsKaruna Therapeutics jobsKaryopharm Therapeutics jobsKiira jobsKiniksa Pharmaceuticals jobsKite Pharma jobsKlarity Health jobsKrystal Biotech jobsKyowa Kirin jobsKyverna jobsKyverna Therapeutics jobsLENZ Therapeutics jobsLIfeMD jobsLabcorp jobsLee Health jobsLegion Health jobsLief Therapeutics jobsLifeStance Health jobsLifestyleRx jobsLittle Otter jobsLivongo jobsLongboard Pharmaceuticals jobsLumeris jobsLuna jobsLundbeck jobsLykos Therapeutics jobsLyra jobsM3 jobsMBX Biosciences jobsMCG Health jobsMDLIVE jobsMEDIjobs jobsMagellan Health jobsMantra Health jobsMarathon Health Inc jobsMartin Army Community Hospital jobsMass General Brigham jobsMaven Clinic jobsMcKesson jobsMechanism Ventures jobsMediBuddy jobsMedical College of Wisconsin jobsMedical University of South Carolina jobsMednet jobsMedpace jobsMedtronic jobsMemora Health jobsMerative jobsMerck jobsMercy Health jobsMidi Health jobsMiga Health jobsMindCare Solutions jobsMindbloom jobsMindoula Health jobsMinuteClinic jobsModRN Health jobsMoffitt Cancer Center jobsMolina Healthcare jobsMondelez International jobsMonogram Health jobsMontefiore Medical Center jobsMonument jobsMosaic Life Care jobsMount Sinai Health System jobsMovn Health jobsMoxie jobsN-Power Medicine jobsNCR jobsNEA Baptist jobsNatera jobsNeko Health jobsNeumora jobsNeura Health jobsNeurocrine Biosciences jobsNew Century Health jobsNew York Life Insurance jobsNoom jobsNorthwell Ventures jobsNovant Health jobsNovartis jobsNovo Nordisk jobsNovo Nordisk US jobsNutrafol jobsNuvoAir jobsOSF HealthCare jobsOak Street Health jobsOchsner Health jobsOncoHealth jobsOne Medical jobsOpenLoop jobsOphelia jobsOptions MD jobsOptum jobsOrdinary Folk jobsOrganogenesis jobsOscar Health jobsOsmosis jobsOtsuka Pharmaceutical Companies jobsOurHealth jobsPRECISIONvalue jobsPacific Northwest National Laboratory jobsPair Team jobsPall jobsPalta jobsParadigm jobsParexel jobsParsley Health jobsPartners In Health jobsPath jobsPeloton Therapeutics jobsPenn Medicine Lancaster General Health jobsPenn State Health jobsPeraton jobsPersonal Genome Diagnostics jobsPfizer jobsPhoenix jobsPhoenix Digital Health jobsPiedmont Healthcare jobsPine Park Health jobsPlug Power jobsPlume jobsPlushCare jobsPocket Naloxone jobsPomelo Care jobsPortrait jobsPoseida Therapeutics jobsPrecision For Medicine jobsPrecision Medicine Group jobsPresbyterian Healthcare Services jobsPrilenia jobsPrivia Health jobsProthena jobsPursueCare jobsQuadrant Biosciences jobsQuartet Health jobsQuidelOrtho jobsRTI International jobsRWJBarnabas Health jobsRadiology Partners jobsRappore jobsRaytheon Technologies jobsRedesign Health jobsRegroup Therapy jobsReliance Health jobsRemeGen Biosciences jobsReplimune jobsRestore Hyper Wellness jobsRevero jobsRho jobsRialtic jobsRippl jobsRippl Care jobsRo jobsRoyal Caribbean Group jobsRula jobsRune Labs jobsSAGE Therapeutics jobsSSM Health jobsSSM Health Cardinal Glennon Children's Hospital jobsSaint Louis University jobsSana jobsSana Benefits jobsSana Biotechnology jobsScholar Rock jobsScience Magazine jobsSeason Health jobsSeasoned Recruitment jobsSecond Opinions jobsSensible Care jobsSeon Design jobsSesame jobsSharpRank jobsShriners Children's jobsSitka Medical Associates jobsSketchy jobsSmarterDx jobsSolace jobsSolace Health jobsSoligent jobsSomatus jobsSonderMind jobsSonova Group jobsSpark Therapeutics jobsSpora Health jobsSprinter Health jobsSt. Bernard's Healthcare jobsState University of New York Upstate Medical University jobsSteadyMD jobsStealth Ventures at Redesign Health jobsStryker jobsSummit Spine and Joint Centers jobsSurgery Partners jobsSynapticure jobsTESARO jobsTailorCare jobsTakeda Pharmaceutical Company Limited jobsTalkiatry jobsTalkspace jobsTeladoc Health jobsTeleClinic jobsTelemedi jobsTembo Health jobsTempus jobsTempus Labs jobsThe Permanente Medical Group jobsThe Skin Clique jobsThermo Fisher Scientific jobsThree Wire Systems jobsTimelyMD jobsTravere Therapeutics jobsTrialSpark jobsTrinity Health (HQ Michigan) jobsTris Pharma jobsTutorfly jobsTwin Health jobsU.S. Bancorp jobsU.S. Department of Veteran Affairs jobsUNC Health jobsUPMC jobsUSAA jobsUWorld jobsUltragenyx Pharmaceutical jobsUnitedHealth Group jobsUnitedHealthcare jobsUnityPoint Health jobsUniversity Marine Medical jobsUniversity of Colorado Health jobsUniversity of Maryland Medical Systems jobsUpScriptHealth jobsUpToDate jobsVIGILINT jobsVarsity Spirit jobsVeeam Software jobsVentureFizz jobsVera Therapeutics jobsVerily jobsVertex Pharmaceuticals jobsVida Health jobsViewFi jobsVir Biotechnology jobsVirta Health jobsVisana Health jobsVitable Health jobsViventium jobsVizient jobsVynca jobsW.L. Gore & Associates jobsWayUp jobsWeightWatchers jobsWelbeHealth jobsWellBe Senior Medical jobsWellinks jobsWest Virginia University Medicine jobsWheel jobsWinona jobsWorkit Health jobsWunderman Thompson jobsX4 Pharmaceuticals jobsXSOLIS jobsYou Health Medical Groups jobsZivian Health jobsbioMérieux jobschiesirarediseases.com jobsinsitro jobsmyLaurel jobs
"Cancer Treatment Centers of America, part of City of Hope" jobs"Peprotech, Inc" jobs"Strategic Education, Inc." jobs25Madison jobs4D Molecular Therapeutics jobsAMBOSS jobsAVITA Medical jobsAbbVie jobsAbbott jobsAbi Global Health jobsAbleTo jobsAcadia Pharmaceuticals jobsAccompany Health jobsAccuity jobsAcentra Health jobsAda Health jobsAdventist Health jobsAffect Therapeutics jobsAlcon jobsAlector jobsAledade jobsAligned Modern Health jobsAll Care Therapies jobsAllara Health jobsAllina Health Mercy Hospital jobsAllucent jobsAlpha Medical jobsAlpine Immune Sciences jobsAmaze Health jobsAmeriHealth Caritas jobsAmerican Institutes for Research jobsAmgen jobsAmplify Education jobsAmplifyMD jobsAmylyx Pharmaceuticals jobsAntara Health jobsAnthem Blue Cross & Blue Shield jobsApellis Pharmaceuticals jobsApogee Therapeutics jobsArcus Biosciences jobsArcutis Biotherapeutics jobsArdent Health Services jobsArise jobsAristaMD jobsArivinas jobsArray Behavioral Care jobsArrowhead Pharmaceuticals jobsAscendis Pharma jobsAscension Health jobsAssure Health jobsAstellas Pharma jobsAstraZeneca jobsAtara Biotherapeutics jobsAtriCure jobsAtrium Health jobsAtrius Health jobsAtropos Health jobsAuthor Health jobsAvidity Biosciences jobsAxia Women's Health jobsAzur Pharma jobsBD jobsBHG jobsBJC Healthcare jobsBank of America jobsBanner Health jobsBaptist Health jobsBassett Healthcare Network jobsBaxter International jobsBayada jobsBayer jobsBaylor Scott & White Health jobsBeacon Roofing Supply jobsBeckman Coulter jobsBehavioral Health Group jobsBeiGene jobsBend Health jobsBento jobsBeth Israel Deaconess Medical Center jobsBicycle Health jobsBillionToOne jobsBiodesix jobsBiofourmis jobsBiogen jobsBiogen Idec jobsBlink Charging Co jobsBlockchain & Climate Institute jobsBlue Cross Blue Shield of North Carolina jobsBlueVoyant jobsBlueberry Pediatrics jobsBluebird Bio jobsBoehringer Ingelheim jobsBon Secours Baltimore Hospital jobsBoston Medical Center jobsBrave Health jobsBridgeBio Pharma jobsBrightView jobsBrighter.com jobsBrightline jobsBristol-Myers Squibb jobsCG Oncology jobsCHI Franciscan Health jobsCORE (Community Organized Relief Effort) jobsCSL jobsCVS Health jobsCabaletta Bio jobsCalian jobsCancer Treatment Centers of America jobsCapella University jobsCarda Health jobsCare Access Research jobsCencora jobsCengage Learning jobsCentene jobsCerebral jobsCerevel Therapeutics jobsCharlie Health jobsChatsworth Management jobsChildrens Hospital of Los Angeles jobsCircadia Health jobsCircle Medical jobsCircle Medical with UCSF jobsCircuit Clinical jobsCity of Hope jobsCityblock Health jobsClay jobsCleveland Clinic jobsCloudflare jobsClover Health jobsCogent Biosciences jobsCohere Health jobsCoherus BioSciences jobsCommonSpirit Health jobsComprehensive Rehab Consultants jobsConcentra Managed Care jobsConcert Health jobsCopilotIQ jobsCorewell Health jobsCullinan Oncology jobsCurai Health jobsCurana Health jobsCurative jobsCurv jobsCytokinetics jobsDNA Capital jobsDaiichi Sankyo jobsDane Street LLC jobsDay One Biopharmaceuticals jobsDaybreak Health jobsDeep Science Ventures jobsDendreon jobsDevoted Health jobsDimensions Centre jobsDirectShifts jobsDispatchHealth jobsDiverge Health jobsDiversified Radiology jobsDocMatter jobsDocPlanner jobsDoctor Anywhere jobsDone jobsDovetail Health jobsDoximity jobsDrHouse jobsDurham Technical Community College jobsEBSCO jobsEating Recovery Center jobsEden Health jobsEisai jobsEli Lilly jobsEli Lilly & Co jobsEmergent BioSolutions jobsEnable My Child jobsEnara Health jobsEquip Health jobsEsperta Health jobsEucalyptus jobsEverly Health jobsEvernorth jobsEvernow jobsEversana jobsEvry Health jobsExact Sciences jobsExelixis jobsExploreLearning jobsExpress Scripts jobsExpressable jobsFHI 360 jobsFORM jobsFabric jobsFairview Health Services jobsFamily Care Center jobsFella jobsFidelity jobsFifty Years jobsFirefly Health jobsFlexJobs Corporation jobsFlywire jobsFog Pharmaceuticals jobsForefront Telecare jobsForesight Mental Health jobsForm Health jobsFort Health jobsForum Ventures jobsForward jobsFoundation Medicine jobsFranklin University jobsFreenome jobsGSK jobsGabbi jobsGabi jobsGalapagos jobsGalileo jobsGameto jobsGeneral Motors Ventures jobsGenmab jobsGenoa Telepsychiatry jobsGenomics Inc jobsGeron Corporation jobsGilead Sciences jobsGlocal Healthcare jobsGrifols jobsGroups jobsGroups Recover Together jobsGuardant Health jobsGuardians jobsGuidehouse jobsHCA jobsHarmonyCares jobsHarrow jobsHazel Health jobsHeadlight jobsHeadspace Health jobsHeadway jobsHealthHero jobsHealthTap jobsHeliosX jobsHenry Meds jobsHerff Jones jobsHeron Therapeutics jobsHerself Health jobsHinge Health jobsHint Health jobsHippocratic AI jobsHireArt jobsHive Health jobsHoag Hospital jobsHone Health jobsHonest Medical Group jobsHorizon jobsHumana jobsIMA Medical Group jobsIMVT Corporation jobsIdeal Option jobsImagine Pediatrics jobsImmunityBio jobsImmunocore jobsInSightec jobsInStride Health jobsIncluded Health jobsIncyte jobsIndiana University Health jobsInfermedica jobsInflow jobsInsmed Incorporated jobsIntellihealth jobsIntercept Pharmaceuticals jobsInternational Medical Corps jobsInvitae jobsIovance Biotherapeutics jobsIsaac Health jobsIssac Health jobsJAMA Network jobs

© 2024 RemotePhysicianJobs.org. All rights reserved.

Some logos provided by Clearbit.

Get matched with jobs