COMPUTER SKILLS:

• MS Project, SharePoint, Windows, Microsoft Word, Excel, Powerpoint, Access
• Expert in Argus, Aris - g, Clintrace, Oracle-based safety databases
• Knowledgeable regarding GCPs, ICH and FDA guidances and regulations

WORK EXPERIENCE:

Confidential, Cambridge, MA

Senior Clinical Narrative Writer (Remote Consultant)

Responsibilities:

• Supporting the overall clinical study patient narratives process for CSRs by authoring and coordinating the clinical study patient narratives for assigned studies
• Authoring clinical study patient narratives for assigned studies
• Reviewing work of other writers (in - house or consultant) for accuracy, quality, focus, and adherence to format and stylistic requirements
• Reviewing data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation

Confidential, Bridgewater, NJ

Senior Pharmacovigilance Scientist (Consultant)

Responsibilities:

• Performed routine safety surveillance/signal detection
• Facilitated signal management process for assigned products (i.e. signal tracking, data analysis, leading review meetings, and presenting)
• Involved with updating labeling
• Contributed to/creation of regulatory responses
• Performed medical literature review and summarizing information
• Reviewed outsourced reports
• Contributed and reviewed aggregate safety reports (PSUR, PBRER, RMP, DSUR)
• Authoring of Safety Evaluation Reports and (SERs) and ACOs
• Supporting Global Safety Officer with other safety related activities i.e. regulatory filings, benefit risk assessment, safety risk management and risk minimization activities (i.e. RMPs and REMS)

Confidential, Waltham, MA

PV Agreements Manager

Responsibilities:

• Initiated, reviewed, and updated pharmacovigilance agreements (PVAs) as required
• Facilitated and participated in cross-functional team meetings to develop PVAs
• Created and maintained relationships with cross-functional team and with business partner representatives to facilitate PVA development
• Acted as a liaison with Global PV and international affiliates
• Maintained and updated PVA data collection and tracking system for PVAs and other agreements
• Managed active and terminated PVAs as well as notifications to partners
• Responsible for sending out PVA checklists to partners
• Responsible for storage and maintenance of PVAs and PVA templates in Sharepoint
• Provided and documented AE reporting training to Business Partners and vendors in consort with execution or revisions of PV agreements
• Assisted with general pharmacovigilance activities as needed (compliance, safety sciences, metrics)
• Responsible for oversight of vendors and partners’ compliance based on agreements

Confidential, Summit, NJ

Oncology Clinical Narrative Writer (Consultant)

Responsibilities:

• Supported the overall clinical study patient narratives process within Hematology/Oncology by authoring and coordinating the clinical study patient narratives for assigned studies
• Authored clinical study patient narratives for assigned studies
• Reviewed work of other writers (in-house or consultant) for accuracy, quality, focus, and adherence to format and stylistic requirements
• Reviewed data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation

Confidential, Princeton, NJ

PV Agreements Manager (Consultant)

Responsibilities:

• Initiated, reviewed, and updated pharmacovigilance agreements (PVAs) as required
• Led and participated in cross-functional team meetings to develop and update PVAs
• Acted as liaison with cross-functional team, business partner representatives, and international affiliates
• Created tracking system for PVAs and other agreements
• Managed active and terminated PVAs as well as notifications to partners for creation or updating of PVAs
• Responsible for sending out PVA checklists to partners and manage data collection
• Responsible for storage and maintenance of PVAs and PVA templates in Sharepoint

Confidential, Princeton, NJ

Senior Project Manager (Consultant)

Responsibilities:

• Performed routine safety surveillance/signal detection and literature review
• Facilitated signal management process for assigned products (i.e. signal tracking, data analysis, leading review meetings, and presenting)
• Led Safety Management Team meetings and escalation of safety issues to Medical Safety Review Team meetings and provided final minutes and action items/decisions log
• Facilitated Medical Safety Review Team meetings and provided final minutes
• Contributing and reviewing of aggregate safety reports (PSUR, PBRER, RMP, DSUR)
• Responsible for supporting departmental and corporate initiatives to drive process improvements within Global Pharmacovigilance Department
• Facilitated the review of development projects and initiatives with senior management, made recommendations for action and ensured appropriate follow-up by management to achieve approved program/project objectives
• Supported the Global Pharmacovigilance Department toward implementation of strategic and operational plans and track progress to goals
• Responsible for maintenance of the project actions, risks, decisions and issues log for project team interactions
• Notified and escalated issues, risks, and outcomes to senior management and governance bodies

Confidential, Berkeley Heights, NJ

Senior Manager (Consultant)

Responsibilities:

• Updated Risk Management Plans (RMPs) of all Confidential marketed products with benefit-risk information, safety concerns, and signal evaluation
• Initiated risk management plans’ updates as described in Work Practice
• Ensured implementation of risk minimization activities globally according to RMPs
• Tracked implementation of additional PV activities
• Monitored compliance with risk management post-marketing commitments
• Provided compliance reports to senior management
• Escalated risk minimization issues to relevant internal stakeholders (i.e. risk management and safety groups)
• Acted as liaison with cross-functional teams to facilitate communication regarding risk minimization activities
• Disseminated risk management standards to Confidential departments and partners
• Responsible for oversight of the maintenance and updates of a (Risk Management) RM electronic repository with RM designee Europe
• Responsible for management of timelines for RMPs
• Assisted in the delivery of RM standards documents
• Updated SOPs and Work Instructions within Global Drug Safety and Risk Management Department

Confidential, Parsippany, NJ

Drug Safety Manager

Responsibilities:

• Managed and provided oversight of case management and PV operations on adverse events reports originating in US
• Ensured consistency and quality in adverse event processing
• Ensured quality and timely submissions ICSRs and aggregate reports
• Provided guidance and review of PV agreements and managed vendor contracts
• Responsible for oversight of vendors/CROs and business partners’ compliance to agreements
• Drafted and managed clinical contracts
• Negotiated financial terms and budgets with CROs
• Responsible for leading meetings cross-functionally and with CROs
• Mentored and provided training to the Confidential
• Performed weekly and monthly team metrics measuring performance, quality, timeliness and productivity
• Represented company during regulatory inspections and internal on-site audits
• Updated and maintained SOPs, Work Instructions, Guidelines and Templates to meet applicable regulations and legal requirements
• Responsible for ensuring department compliance with company objectives, regulatory requirements and regulations
• Supported preparation and development of clinical aggregate reports
• Supported signal detection processes and activities

Confidential, Spring Valley, NY

Drug Safety/Risk Management Specialist

Responsibilities:

• Performing routine safety surveillance/signal detection and literature review
• Facilitating signal management process for assigned products (i.e. signal tracking, data analysis, leading review meetings, and presenting)
• Contributing and reviewing of aggregate safety reports (PSUR, PBRER, RMP, DSUR)
• Responsible for the implementation and oversight of REMS program for Oral Transmucosal Fentanyl Citrate (OTFC) and Extended-release/Long Acting Opioids
• Reviewed assessment and submission documents for REMS programs
• Provided leadership and expertise for risk assessment, risk management, and risk mitigation
• Ensured risk minimization measures implemented through REMS programs and measured compliance
• Escalated risk minimization issues to senior management
• Provided a lead role in establishing a governance model with streamlined pathway for safety risk management related responsibilities and activities; signal detection and processes
• Provided medical review of all adverse event reports and PADERs
• Updated and reviewed SOPs and Work Instructions
• Acted as subject matter expert for pre-audit preparedness and during audit and inspections

Confidential, Pearl River, NY

Manager, Adverse Event Reporting Group

Responsibilities:

• Managed Adverse Event Reporting Group and daily operations
• Served as primary contact and liaison for CROs and stakeholders
• Drafted and managed clinical contracts
• Negotiated with CROs financial terms and budgets
• Responsible for leading cross-functional meetings and meetings with CROs
• Performed oversight of CROs
• Developed Safety Monitoring Plans for CROs
• Quality checked all serious adverse event reports from clinical trials
• Prepared and conducted monthly Safety Review Team Meeting with Medical Monitors
• Updated and reviewed SOPs and Work Instructions
• Acted as subject matter expert for pre-audit preparedness and during audit and inspections