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Associate Director, DSPV Operations

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

Job Description:

Company: HCPro, Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Reporting to the Sr. Director of Operations, Drug Safety andPharmacovigilance (DSPV), the Associate Director, DSPV will play akey role in the Drug Safety and Pharmacovigilance Operations acrossthe Postmarketing and Clinical Development program.

The Associate Director, DSPV Operations provides leadershipthrough independently managing the operational activities bothinternally and through a third-party Pharmacovigilance contractvendor related to the processing of adverse events from clinicaltrials and Postmarketing surveillance and ensures that performedtasks comply with DSPV SOPs and procedures, best industry standardsand applicable regulations.

Required Skills Independently manages the third-partyPharmacovigilance vendor outsourced Clinical Trial andPostmarketing Surveillance activities.

Provides sponsor oversight of SAE processing by outsourcedvendors, including the review and monitoring of compliance throughvarious monitoring reports and other oversight activities andensures the implementation of effective corrective and preventativeaction plans.

Participates in the review and execution of DSPV Operationssafety data collection and processing and execution strategy acrossprograms.

Maintains knowledge of adverse event reporting process andsafety system and contributes to the development, implementation,improvement, and standardization of new processes, methods, anddatabases.

Actively participates in the quality review of SAEs and SUSARsfollowing data entry by vendor. Specific focus on accuracy ofnarrative to reflect source documentation, MedDRA coding, andappropriateness of queries to seek follow-up from the clinicalsites.

Represents DSPV on clinical development teams, as assigned.

Collaborates with contract service providers regarding adverseevent reporting for Postmarketing Surveillance activities asrequired.

Collaborates with Medical Affairs personnel on InvestigatorSponsored Research programs as required.

Ensures compliant exchange of safety data between Akebia and itspartners.

Participates in the creation and dissemination of appropriatesafety reporting language in clinical trial key documents.

Participates in authoring and QC of periodic safety reports(e.g., DSUR, PSUR, IND annual reports)

Provides safety operations support for external submissions,signal detection and risk management planning activities.

Authors governing documents, such as SOPs, Work Instructions andSafety Management Plans.

Monitors compliance with regulations, PV agreements and internalSOPs.

Participates in the quality management system in Drug Safetyincluding ensuring department standards are met, including trainingrequirements, monitoring performance, implementing continuousimprovement actions and good documentation practices.

Works with QA department to maintain a state of high PVinspection readiness across all regions/countries.

Participates in internal audits and global regulatoryinspections including MHRA/FDA/EMA etc. as a SME for specific PVtopics and processes.

Contributes to formal responses to inspection and audit findingsrelated to DSPV department.

Supervision and direct management of internal safety operationspersonnel as the department expands.

Assists in performing additional ad hoc activities asassigned.

Collaborates with Medical Affairs personnel on InvestigatorSponsored Research programs as required.

Ensures compliant exchange of safety data between Akebia and itspartners.

Participates in the creation and dissemination of appropriatesafety reporting language in clinical trial key documents.

Participates in authoring and QC of periodic safety reports(e.g., DSUR, PSUR, IND annual reports)

Provides safety operations support for external submissions,signal detection and risk management planning activities.

Authors governing documents, such as SOPs, Work Instructions andSafety Management Plans.

Monitors compliance with regulations, PV agreements and internalSOPs.

Participates in the quality management system in Drug Safetyincluding ensuring department standards are met, including trainingrequirements, monitoring performance, implementing continuousimprovement actions and good documentation practices.

Works with QA department to maintain a state of high PVinspection readiness across all regions/countries.

Participates in internal audits and global regulatoryinspections including MHRA/FDA/EMA etc. as a SME for specific PVtopics and processes.

Contributes to formal responses to inspection and audit findingsrelated to DSPV department.

Supervision and direct management of internal safety operationspersonnel as the department expands.

Assists in performing additional ad hoc activities asassigned.

Required Experience Basic Qualifications:

Bachelor’s degree in nursing, pharmacy, or other health carerelated profession or life sciences preferred or equivalentqualification/work experience.

Minimum of 3-5 years of experience in DrugSafety/Pharmacovigilance in a pharmaceutical industry setting orthe equivalent.

Minimum of 2 years of experience managing with third-partyPharmacovigilance vendors, CROs, and business alliance relationshipmanagement.

Minimum of 2 years managing direct reports.

Preferred Qualifications:

Global pharmacovigilance operations experience with marketedproducts and/or products in development.

Knowledge of relevant ICH, European Commission, and FDA Guidanceand Regulations governing adverse event processing and reportingfrom clinical trials and/or Postmarketing surveillance.

Experience working with Safety databases and systems (Arguspreferred)

Experience with MedDRA coding and data entry.

Strong analytical and problem-solving skills with superbattention to detail.

Strong verbal, written technical communication and presentationskills.

Must work effectively/collaboratively in a fast-paced teamenvironment and with individuals at all levels within anorganization.

Proven ability to work within a cross-functional, matrixed teamwith the ability to manage multiple tasks with competingtimelines.

Akebia Therapeutics, Inc. is a fully integratedbiopharmaceutical company focused on the development andcommercialization of therapeutics for people living with kidneydisease. The Company was founded in 2007 and is headquartered inCambridge, Massachusetts. For more information, please visit ourwebsite at www.akebia.com .

Akebia is an equal opportunity employer and welcomes all jobapplicants. All qualified applicants will receive consideration foremployment without discrimination on the basis of race, color,religion, sex, sexual orientation, gender identity, nationalorigin, protected veteran status, disability, or any other factorsprohibited by law.

Keywords: HCPro, Inc., Cambridge , Associate Director, DSPV Operations, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Associate Director, DSPV Operations, Other , Cambridge, Massachusetts

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