Maria M. Email & Phone Number

Pomona, Ny, Us

Mumbai, Maharashtra, In

Represent the Pharmacovigilance department locally and at a global level as an authoritative and professional member of relevant teams providing functional area expertise to internal and external partners• Review and provide guidance into safety sections of study related documents (study protocols, IB, ICF, CRFs SAEs forms, clinical study reports, SMPs, briefing documents) as required• Provide input into the development and review of safety reports (DSURs, IND reports, PADERS, PSUR /PBRER, Addendum to Clinical Overview, Benefit-Risk reports, RMPs/REMS etc.) and support product registration and renewals activities.• Participate in the discussions and evaluation of safety issues/signals impacting risk- benefit.• Understand the business model and risks in each country in the region and work closely with the commercial teams to ensure appropriate PV support is implemented• Responsible & accountable for ensuring compliance towards local regulatory requirements and ensure PV system is in alignment with current local regulations within USA & Canada region• Accountable to implement , monitor and support PV Staff KRAs, (LPVRP KPIs) and departmental Metrics• Responsible & accountable to ensure selection, induction & ongoing training compliance of PV staff in assigned region• Work closely with the Head of GPV, Compliance and Training, the QPPV and other PV functional leaders to ensure alignment and consistent implementation of global processes, policies and procedures• Support GPV audit/inspection readiness initiatives and in the event of an audit/inspection of any GPV affiliate support the preparation, execution and responses to audit/inspection including timely management of CAPAs and its effectiveness.• Ensure administrative activities are assigned to staff as appropriate• Lead all recruitment activities at site, PV branding, and PV awareness activities

Bridgewater, New Jersey, Us

Develop and train staff on departmental Standard Operating Procedures, including CAPA and deviations.Lead and participate in the Vendor management activities.Serve as the drug safety expert for Product Strategy development for the Marketing and Regulatory group.Understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format Provide medical safety expertise on data cleaning and reconciliation as required for BLA filingsReview line listings to detect safety signals and present the reviews to the teamWork closely with the Safety Physicians in planning, conducting, and evaluating Phase II, III and IV trials.Perform end of line and medical review of individual case safety reports, including coding, seriousness, expectedness and company causality assessment for assigned protocols from global clinical trials and BP (business partner) studies using EDC, Argus and MedDRA databases.Apply medical expertise to determine or confirm the need for expedited reporting to global regulatory agencies and comply with unique safety reporting guidelines in specific countriesMaintain and apply knowledge of global regulatory authority regulations (especially FDA and EMEA)Ensure the accuracy and completeness of case reports by generating medical queries and communicating to corresponding investigational sitesDevelop strong working relationships with colleagues, including but not limited to: Clinical Safety Scientists, Clinical Directors in Clinical Research, Quality, Marketing, and Regulatory departmentsAct as the extended member of the Risk Management Safety Teams (RMST's) for assigned products and provide input to identify safety signals and risk detectionProvide project management skills to develop and implement projects to ensure quality and efficient business processesParticipates in organizational risk management activities for assigned REMS products.

Middletown, New York, Us

- Promote collaborative cost-effective safe medication practices that improves patient outcomes-Implement medication safety and cost saving strategies-Design and deliver pharmacology related educational programs to a wide range of health care providers-Develop patient safety initiates to meet regulatory requirements such as: safe medication management, anticoagulation stewardship, opioid stewardship, antimicrobial stewardship, pharmacy renal dosing program, and geriatrics safety initiatives -Collect, review and report adverse medication events internally and to regulatory bodies as required- Manage ADR hotline and implement CAPA as needed -Utilize departmental metrics to track utility and improve services-Participate in annual budgeting process and recommends cost projections -Maintain hospital formulary system, medication infusion database, and evaluate new drug for inclusions-Review and disseminate periodic drug safety reviews from ISMP and FDA to affected stakeholders-Provide on-call staff support and responds to escalated medication inquiries from healthcare providers -Develop and maintain various clinical guidelines and medication use policies and procedures-Establish collaborative medication management practices through active participation in various multidisciplinary committees such as Pharmacy and Therapeutics Committee, Antimicrobial Stewardship Committee, Critical Care & pulmonary Committee, Infection Control, Pediatrics Committee and Medication Management -Participate in internal audits and inspections to ensure compliance with states regulatory bodies including Joint commission/ DNV

-Collaboratively implemented and managed Antimicrobial stewardship program -Participated in daily ICU interdisciplinary rounds in a 40 bed Adult ICU-Developed and maintained hospital wide medication Infusion guideline.-Maintained Hospital medication infusion pump library-Mentored APPE/IPPE Pharmacy students on rotation-Provided education for pharmacy, nursing and medical staff-Collaboratively developed various treatment ordersets and protocols-Collaborated with IT in enhancing safe medication practices using Electronic Medical Record-Led various medication utilization evaluations with the goal of optimizing positive medication outcomes and implementing cost minimization strategies-Adjunct Professor at Albany College of Pharmacy-Participated in Clinical Research activities and Staff education

-Participated in daily interdisciplinary rounds on patient care units with various care teams.-Conducted medication utilization reviews-Provided education to pharmacy, nursing and medical staff-Compounded IV Medications-Participated in Clinical Research and Publication Activities

Philadelphia, Pennsylvania, Us

-Ensure safe and accurate medication dispensing activities-Provided patient education -Resolved medication issues such as drug interactions or insurance related concerns-Managed pharmacy personnels and ensured compliance with local, state and federal regulations -Provided immunization for patients -Maintained Pharmacy inventory management

Master Of Business Administration - Mba, Health/Health Care Administration/Management

Pgy-1 Pharmacy Residency Program

Doctor Of Pharmacy - Pharmd, Pharmacy

Associates In Science, Science

Doctor Of Pharmacy - Pharmd