Sr Manager, Global Patient Safety & Risk Management

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Sr Manager, Global Patient Safety & Risk Management Company: Alnylam Pharmaceuticals

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Association of Certified Anti-Money Laundering Specialists(ACAMS) Sr Manager, Global Patient Safety & Risk Management -RD2020T1005

AP Sr Manager, Global Patient Safety & Risk Management -RD2020T1005 Alnylam Pharmaceuticals

Cambridge, Massachusetts, United States

1 day ago

Description

Senior Manager, Quality Standards and Compliance (QSC), GlobalPatient Safety & Risk Management

Founded in 2002, Alnylam was built upon a bold vision of turningscientific possibility into reality by harnessing the power of RNAifor human health as an innovative new class of medicines. We are agrowing biopharmaceutical company with two approved medicines and arobust pipeline of investigational medicines focused in fourstrategic therapeutic areas: genetic medicines, cardio-metabolicdiseases, infectious diseases, and central nervous system (CNS) andocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,400people in 19 countries and is rapidly growing globally, withadditional offices in Norton, Mass., Maidenhead, U.K., Zug,Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam isproud to have been recognized as one of The Boston Globe’s TopPlaces to Work five years in a row (2015-2019), a Great Place toWork in the U.K. and Switzerland in 2020 and Science Magazine’s #1Top Employer in 2019. Please visit www.alnylam.com for moreinformation.

The Senior Manager of Quality Standards and Compliance isresponsible support the development, implementation, and oversightof all quality aspects of the Global Patient Safety (GPS) QualityManagement System. These activities include but are not limited tothe following: Audit and Inspection Readiness, Training, PVDeviation Investigation Management, Ad-hoc and Aggregate Report QC,PV Regulatory Intelligence, PV Agreement Maintenance, KeyPerformance Indicators (KPIs), Process Improvement, and GPSDocumentation Management.

Summary of Key Responsibilities

Support development, implementation, and oversight of quality &compliance activities in support of GPS which include, but are notlimited to the following:

Supports compliance evaluation and review function for GPSprocedures

Helps to track and monitor quality system KPIs / QPIs to conductanalysis for Alnylam’s GPS Organization

Develops and reports pharmacovigilance compliance metricsrelated to GPS activities to ensure appropriate levels ofoperational performance & compliance

Supports the development, documentation, monitoring, and followup of corrective and preventive actions related to PV operationsactivities to address GPS compliance risks and ensure timelycompletion

Assists the development of content for SOP documentation &management, as requested

Supports the development and implementation of measures tomanage compliance and oversight of external groups, vendors andaffiliates that impact GPS deliverables (contractual partners,vendors, client groups, CROs, etc.)

Coordinates and collaborates with the Training department toensure delivery of role-based content, as requested

Works with cross-functional teams to advance quality activitiesrelating to Alnylam Pharmaceuticals

Requirements

Qualifications

Education : Bachelor’s degree in life sciences or related field.Master’s degree preferred although not required.

Experience : Minimum of 5 years in the pharmaceutical industrywith a demonstrated focus on PV operations, quality, and compliancein a global environment. Knowledge of relevant FDA, EMA andInternational Conference on Harmonisation (ICH) guidelines,including Good Vigilance Practices (GVP) guidelines. Workingknowledge of MedDRA coding and Argus Safety database a plus.Specific experience in rare diseases therapeutic area at a globallevel is an advantage

Strong skills and experience in:

Demonstrates expertise related to understanding the principlesand application of quality and regulatory compliance

Demonstrates aptitude for facilitating group or project teamendeavors, and building team unity

Demonstrates ability to effectively communicate and influencethe outcomes of the decision-making process

Maintains a contemporary knowledge of current industry trends,standards and methodologies as it relates to PV qualitymanagement.

May conduct presentations on quality issues, initiatives andprojects at cross functional meetings

Special Skills : Ability to represent the functional departmentas an internal and external contact on PV Quality deliverablesrelating to Global Patient Safety & Risk Management. Strongnegotiation skills encouraging discussion and driving decisions todesired results.

Job Complexity : Support Quality Pharmacovigilance Activitiesfor the GPS Department. Support cross-function relationships aswell as those with business partners and CROs.

Supervision : Position will report directly to (Associate)Director, Global Patient Safety & Risk Management. Individual isexpected to work independently with support from management andcolleagues in Global Patient Safety & Risk Management. Thisindividual will communicate and collaborate with GPS subject matterexperts to optimize departmental compliance and quality.

Alnylam Pharmaceuticals is an EEO employer committed to anexciting, diverse, and enriching work environment.

LI#JR1

Job Information

Job ID: 54440591

Location:

Cambridge, Massachusetts, United States

Position Title: Sr Manager, Global Patient Safety & RiskManagement - RD2020T1005

Company Name: Alnylam Pharmaceuticals

Job Function: Management

Job Type: Full-Time

Job Duration: Indefinite

Min Education: BA/BS/Undergraduate

Min Experience: 5-7 Years

Required Travel: None

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