Associate Director, Safety Scientist Boston, Massachusetts, United States of America LGY_CDSU -[...]
$126k - $190kAlexion Pharma Spain S.L.
- # Associate Director, Safety ScientistBoston, Massachusetts, United States of AmericaApply NowFind out how well you match with this jobThe Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.**You will be responsible for:*** Managing safety scientist activities across multiple product portfolios and/or indications* Organizing, training and/or supporting junior safety scientists and fellows* Supporting activities related to new drug applications and other regulatory filings* Representing global patient safety at regulatory inspections e.g., MHRA, FDA, EMA, etc.* Leading gap analysis to ensure alignment with changes in global regulations* Strategizing and drafting of responses to regulatory inquiries on product safety issues inclusive of defining MedDRA search strategy* Representing GPS in global program teams and associated cross functional teams and/or projects as needed* Proactively providing guidance and educational training to GPS therapeutic teams* Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors* Performing Signal Surveillance activities for respective programs in collaboration with GPS Medical Directors* Project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with GPS Medical Directors* Authoring safety sections, in collaboration with team members, on regulatory responses, IBs/CCDS, protocols, ICFs, Data Monitoring Committee reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position.* Manage portfolio of products/projects related to risk management; assists GPS Medical Directors in the development of risk management strategy and activities for assigned products* Contribute to on-going process enhancement for safety analytics and reporting, such as developing standard procedures and templates* Assisting GPS Medical Directors to oversee risk minimization activities including tracking of activities as needed* May be directed by the line function to support initiatives outside of their projects**You must have:*** Bachelor's degree in a biologic/medical/clinical/nursing field* At least 5 years' experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry* Knowledge and understanding of US and EU safety regulations pre- and post- marketing* Experience with Risk Management and Minimization programs* Experience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans* Experience with clinical development including risk/benefit analysis and safety assessment* Strong clinical, analytical, problem solving and scientific writing and communication skills* Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis* Expertise with Microsoft Word, PowerPoint, SharePoint and Excel**Nice to have:*** Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhD* Expertise with clinical and safety databases* Experience in MedDRA coding and search strategies* Excellent, independent judgment based on knowledge and expertise* Strong personal time-management and project-management skills* Knowledge of Power BI, and other visualization tools*The annual base pay ranges from $126,000 to $190,000. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.***Date Posted**16-Jul-2026**Closing Date**31-Jul-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
- J-18808-Ljbffr Alexion Pharma Spain S.L.
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Associate Director, Safety Scientist Boston, Massachusetts, United States of America LGY_CDSU -[...] in Boston, MA vacancy
$112.18k - $168.26k
## Associate Director, Global Category SourcingBoston, Massachusetts, United States of AmericaApply NowFind out how well you match with this jobThe Associate Director, Global Sourcing will develop strong partnerships with functional leaders in the management of external...SuggestedHourly payContract workTemporary workLocal area- ## Senior Director, Field ReimbursementBoston, Massachusetts, United States of AmericaApply NowFind out how well you match with this job**This is what you will do... ...bias toward proactively identifying problems and associated solutions* Proven experience creating and...SuggestedWork at office
$109k - $163.4k
...to-day facilities operations of Hasbro's Boston headquarters and serves as the primary... ...Collaborate with Hasbro's Environmental, Health & Safety (EHS) team to assist in monitoring and... ...naval or air service, participated in a United States military operation for which an Armed...SuggestedContract workTemporary workFor contractorsFor subcontractorInterim roleWork at office- Candidates must reside in the Eastern United States and ideally Boston The Associate Director, Patient Advocacy and Engagement, Rare and Pipeline will play a... ...Science Magazine’s Top Biopharma Employers, one of America’s Most Responsible Companies for 2024 by Newsweek,...SuggestedLocal area
$66k - $99k
...Equipment) required (safety glasses, gowning, gloves... ...) Field Application Scientist, Imaging & Detection... ...the Northeast United States, including MA, CT, RI... ...ideally reside near Boston. Key Responsibilities... ...this position based in Massachusetts is $66,000.00-$99,000...SuggestedTemporary workRemote workWork from homeHome office$93.75k
Sr Associate, Marketing, Intergrated Campaign Manager, State Street, Boston, MA Join to apply for the Sr Associate, Marketing... ...to your success. Country: United States of America Your Journey Starts Here... ...Boston Other Locations: Massachusetts-Boston Organization: Santander...Hourly payFull timeContract workWork experience placementRemote work$154.4k - $242.55k
...Oncology Drug Discovery Unit is seeking an experienced Associate Director to serve as a... ...and mentor scientists contributing to program... ...practices. For Location:Boston, MAU.S. Base... ...in accordance with state or local minimum wage... ...is unlawful in Massachusetts to require or administer...Minimum wageTemporary workLocal area- This is what you will do: The Scientist III will be a key member of the Injectable Drug Product... ...(e.g., mixing, filtration, fill/finish unit operations, hold steps, viscosity... ...solve scientific and operational challenges. Safety & Laboratory Operations — Operating primarily...
$162k - $270k
...Required:NoneWhat You Will Do:Guidehouse is seeking an Associate Director to help lead and grow our State Energy practice across New York and the broader... ...internal meetingsMust reside within New York City, NY or Boston, MADue to nature of client engagements, must either be...Permanent employmentFull timeFor subcontractorFlexible hours$135k - $205k
...Community Inclusion (ICI). The Director will also hold a qualified Associate/Full Professor position in an academic unit within the College of... ...of the University of Massachusetts Boston; and coordinate all ICI activities... ..., federal) and local/state/federal/international...Contract workWork at officeLocal areaUniversity of Massachusetts Boston
Boston, MAmore than 2 months ago$114.2k - $171.4k
...creativity, drives transformation, and delivers impact across our global organization! Effective from the date that Hasbro opens its new Boston location, this position will be onsite Tuesday - Thursday at Hasbro's new HQ location in Boston, MA. In the interim, this position...Temporary workInterim roleLocal areaWorldwide$92.25k - $147.6k
...explorers, pursuing society’s most critical safety and justice issues with our ecosystem of... ...of one of Axon’s US hub sites (Atlanta, Boston, Scottsdale, Seattle, or Sterling metro... ...skills, efforts, or working conditions associated with this job. The job description may...Work experience placementRemote work$20 - $35.72 per hour
...practice locations in eastern Massachusetts. Our entire team of providers... ...: 133 Brookline Avenue, Boston, MA 02215 Department: Laboratory... ...Required Qualifications: ~ Associates degree in a laboratory... ...characteristic protected by local, state, or federal laws, rules, or regulations...Hourly payDaily paidMinimum wageFull timeWork experience placementLocal area$24 - $43 per hour
...practice locations in eastern Massachusetts. Our team of physicians,... ...Location: 133 Brookline Ave, Boston, MA Department: Laboratory... ...Required Qualification: ~ Associates degree in a laboratory science... ...characteristic protected by local, state, or federal laws, rules, or...Hourly payMinimum wageFull timePart timeWork experience placementLocal areaShift work$3,079 per week
...Cath Lab Technologist Jobs in Massachusetts Location Boston, Massachusetts Shift Days, 4x10 hrs Start Date ASAP Duration 13 weeks $3,079 /weekly... ...from Cardiovascular Credentialing International (CCI). Most states have individual licensing requirements through the...Contract workImmediate startShift work- Tango Therapeutics in Boston seeks Associate Director, Pharmacovigilance Scientist to lead ongoing safety surveillance, oversee signal detection, author DSURs and PSURs, and manage regulatory safety reports across the product lifecycle from first‑in‑human studies to global...
$186.3k - $227.5k
...possible. Position Summary The Director, North America Benefits is responsible... ...being programs across the United States and Canada. This role... ...regulations. It is unlawful in Massachusetts to require or administer a... ...here."SummaryLocation: Boston, MA, USAType: Full timeFull timeContract workWork at officeLocal areaImmediate startFlexible hours$151.08k - $226.62k
The Associate Director, US HCP Peer-to-Peer (P2P) Marketing, gMG & NMOSD, Rare Neurology, is a member of the commercial U.S. Rare Neurology business unit and reports to the Sr. Director of HCP Marketing. This position is responsible for the design, development, and delivery...Temporary workWork at officeNight shift- Alexion Pharma Spain S.L. in Boston, MA seeks an Associate Director, Safety Scientist to lead safety activities across product portfolios and collaborate with GPS Medical Directors and cross-functional teams. The role emphasizes risk management, regulatory writing, and...
$45 - $55 per hour
...General Medical Technologist - Boston, MA (8 Hour Nights) Boston, Massachusetts United States Medical Technologist Location: Boston, Massachusetts Pay: $45-$55 / hour Specialty: Generalist Job Type: Travel Job Shift: 8 Hour Nights Contract: 6 Months Credential...Contract workSeasonal workWork at officeShift workNight shift- ...DescriptionGeneral Summary:The Patient Safety Epidemiology Associate Director leads safety and... ...with federal and state requirements. Actual base... ...E-Verify Employer in the United States. Vertex will make reasonable... ...@vrtx.comSummaryLocation: Boston, MAType: Full timeFull timeSummer workWork at officeRemote workFlexible hours2 days per week
$109.4k - $182.3k
...new drugs observational safety studies of marketed products... ...patients’ lives. The Associate Director, Epidemiology Scientist position provides an... ...are located in New York, Boston, MA, Collegeville, PA or... ...the location of hire. The United States salary range provided does...Relocation package2 days per week$89.9k - $250.4k
The Assoc. Director, Solution Sales, Patient Access SupportServices sits in the Patient Access and Support Services... ...or other benefits.SummaryLocation: San Francisco, CA, United States of America; Boston, Massachusetts, United States of America; Wayne, PA, United States...Full timePart timeImmediate startRemote workWork from homeWorldwide$172k - $237k
About This Role As the Associate Director for the Safety Surveillance and Aggregate Reports... ...Do Serve as the lead PV Scientist for a specific product or... ...on individual, business unit and company performance. In... ...protected by federal, state or local law. Biogen is an...Full timeTemporary workWork at officeLocal area$190k - $240k
Location: Boston, US (hybrid) Reporting to: Executive Director, Regulatory Science Orchard Therapeutics... ...in Boston, Massachusetts. Job Summary This role... ...Orchard Therapeutics North America we provide a... ...candidates hired in the United States - and this range is specific...Odd jobLocal area$200k - $300k
...DescriptionGeneral Summary:The Patient Safety Associate Medical Director will provide medical safety expertise, state of the art pharmacovigilance,... ...an E-Verify Employer in the United States. Vertex will make... ...@vrtx.comSummaryLocation: Boston, MAType: Full timeFull timeSummer workRemote workFlexible hours2 days per week$142.5k - $256.5k
The RoleThe Associate Director, Global EHS will serve as a key... ...Health and Safety, Occupational Safety,... ...regions, or business units. Global or multi-site... ...Employer in the United States. We consider qualified... ...SummaryLocation: Norwood, Massachusetts; Technical DevelopmentType...Permanent employmentFull timeFor contractorsWork at officeLocal areaWork from home- ## Scientist, CNS Biology ResearchUnited StatesApply NowFind out how well you match with this jobJob ID3227This role is considered:On-Site... ...affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer. #J-18808-Ljbffr...Full timeContract workTemporary workLocal areaFlexible hours
Alnylam Switzerland GmbH
Cambridge, MA4 days ago $138.4k - $207.6k
...and Technology (AS&T) Principal Scientist, Separation Method Expert,... ...in accordance with federal and state requirements. Actual base salary... ...an E-Verify Employer in the United States. Vertex will make reasonable... ...@vrtx.comSummaryLocation: Boston, MAType: Full timeFull timeContract workWork experience placementSummer workRemote workWorldwideFlexible hours2 days per week$23.62 - $31.69 per hour
Title: Behavior Interventionist (Naturalistic, Play-Based ABA) Cortica is looking for dedicated, compassionate Behavior Technicians to join our growing team and help us design and deliver life-changing care for children with neurodevelopmental differences. At Cortica, ...Hourly payFull timePart timeWork at officeFlexible hoursAfternoon shift2 days per week3 days per weekWeekday work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Associate Director, Safety Scientist Boston, Massachusetts, United States of America LGY_CDSU -[...]. Be the first to apply!
Related searches
- associate marketing manager Boston, MA
- associate director clinical operations Boston, MA
- associate scientific director Boston, MA
- associate media manager Boston, MA
- associate product manager web Boston, MA
- associate manager Boston, MA
- associate director biostatistics Boston, MA
- associate director market research Boston, MA
- associate director clinical data management Boston, MA
- associate media director Boston, MA