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Senior Manager, Pharmaceuticals Resume
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| Desired Industry: Science/Research |
SpiderID: 79778 |
| Desired Job Location: Collegeville, Pennsylvania |
Date Posted: 8/17/2017 |
| Type of Position: Full-Time Permanent |
Availability Date: |
| Desired Wage: 132000 |
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U.S. Work Authorization: Yes |
| Job Level: Management (Manager, Director) |
Willing to Travel: Yes, 50-75% |
| Highest Degree Attained: Other |
Willing to Relocate: No |
Objective:
Detail-oriented and goal-driven professional with extensive experience in research and development encompassing pharmaceutical quality inspection. Known for strong work ethic in accomplishing duties and work responsibilities in a timely manner without compromising accuracy and integrity. Highly commended for excellent analytical and organizational skills in reports generation and resource analysis. Armed with excellent interpersonal skills in building relationship with professionals and individuals of all levels toward company productivity and success.
Experience:
Teva Branded Pharmaceutical Products R&D, Horsham, PA
Senior Manager, Pharmacovigilance Systems Jun 2016–Present
Supervise the United States Global Patient Safety and Pharmacovigilance system, which involves managing portfolio of projects focused on creation of system-related processes.
Communicate with project team’s department-wide to comprehend business processes and requirements, as well as liaise between project teams and Global IT and US PHV teams to ensure proper utilization of resources and systems.
Guarantee availability of sufficient US PHV system support through coordination with the United States IT team.
Oversee Cognos reporting, training, database ad-hoc queries management, file sharing, and database migration from Argus to ARISg.
Display solid leadership skills and flexibility in fulfilling a wide range of roles:
Leader between the business and local and global pharmacovigilance IT teams;
United States representative for the PhV database upgrade project and the E2B (R3) implementation;
Business support for individual case safety report (ICSR) transmission failures to health authorities and partner submissions;
Technical and business process support handling product-specific requirements and regulatory submissions;
Subject matter expert (SME) administering product safety analysis, ad hoc requests, and local Cognos support; and
Development, testing, and implementation of performance qualification (PQ) and user acceptance testing (UAT) for safety database upgrade.
Actively take part with the Inspection Readiness Team throughout local and global audits for inspections for both business partner and health authority.
Pharmacovigilance Manager Dec 2013–Jun 2016
Assumed full accountability in monitoring and managing the Case Processing Team and the Electronic Submission Team in charge of distributing ICSR, SUSARS, attachments, and periodic reports to partners and handling submissions to health authorities.
Took charge of troubleshooting XML submissions, as necessary, while interfacing with FDA.
Directed a team of five direct full-time reports and contractors, in charge of carrying out data entry and ICSR submissions.
Closely coordinated with IT teams to ensure satisfaction of business needs.
Carried out the development, testing, and implementation of performance qualification (PQ) scripts for regular database releases.
Evaluated compliance metrics and corrective and preventive actions (CAPAs), and executed training, planning and implementation of multiple major projects simultaneously including ARISg database upgrade.
Served as a liaison between PhV and cross-pharma groups, which included quality assurance and regulatory compliance, to guarantee efficient and prompt exchange of information.
Managed the staff while determining process improvement opportunities.
Provided assistance during ICRS medical reviews.
Established strong working relationships with all team members, while promoting a collaborative environment.
Innovative Team Leader Jun 2012–Dec 2013
Assisted pharmacovigilance manager in overseeing and training the Case Processing Team.
Served as resource for associates and project lead when assigned, as well as liaison between other associates, outside vendors, and PhV manager.
Partook in the quality control activities as needed to deliver timely review and management of serious and non-serious adverse events for post-marketing ICSRs, in compliance with corporate standard operating procedures (SOP) and health authority regulations such as Food and Drug Administration (FDA), Europe, the Middle East and Africa (EMEA), Medicines and Healthcare Products Regulatory Agency (MHRA).
Managed main areas including E2B, ARISg upgrade, case corrections or redistributions, PQ script writing and execution, and SOP update and work instructions (WIs) whenever necessary.
Prepared periodic adverse drug experience report (PADER) submissions for generic products.
Provided help and monitored team regarding submission of individual electronic common technical document (eCTD) PADER to regulatory affairs and FDA.
Janssen (J&J) Research and Development, Global Medical Safety, Horsham, PA
Senior Submissions Specialist Aug 2010–Jun 2012
Handled local case reporting query management, involving setup, maintenance, and queries oversight.
Delivered on-time E2B or manual submission of ICSRs to regulatory authorities or business partners.
Rendered backup support to other regions for E2B reporting based on business continuity plan and conducted bi-annual review of label-constraint reachability (LCR) queries and training on E2B reporting.
Oversaw delegations of interactions with local safety officers, as well as electronic reporting to global medical safety.
Took part in leading activities with the marketing authorization holder.
Communicated with Local Safety Officer, managed E2B issues and escalation as needed, and helped on audits and inspections.
Contributed on the policy development and process improvement, whenever necessary.
Acted as backup for the manager regarding ICSR submissions and LCR query setup.
Offered overview presentations to local and global staff on FDA and business partner reporting requirements.
Drove efforts on the transition of business partner submissions offshore, which included training, planning, and execution of major projects.
Senior Drug Safety Associate Jun 2007–Aug 2010
Assessed and processed expedited reports to be submitted to worldwide regulatory authorities, which included writing of complete narratives with medical evaluations, coding of appropriate Medical Dictionary for Regulatory Activities (MedDRA), and identification of expectedness of adverse terms of events.
Functioned as SME for GMS in areas of nullification, medical and regulatory relevance, and multiple oncology trials.
Handled monitoring of products for immunology, cardiovascular, dermatology, and oncology; preparation of SUA/SUSAR reports; and collective analysis of specific events in oncology clinical trials.
Played an integral role in serving various high-visibility task force in training other associates worldwide within areas of nullification, deletions, and medical and regulatory relevance, consequently bringing essential improvements in workflow and compliance.
Earlier Position Held:
MedRisk, Inc., King of Prussia, PA
Case Manager Functional Leader
Research Experience
TEVA Neuroscience, Horsham, PA
Drug Safety Associate Jan 2006–Jun 2007
Administered timely review and management of serious (including 15-day reports) and non-serious adverse events for innovative post-marketing and generic products, in compliance with corporate standard operating procedures and health authority regulations such as FDA, EMA, and MHRA.
Held responsibility in evaluating and encoding data of complex legal and literature cases, as well as submitting PADER of branded and generic products.
Gathered, summarized, and followed up information regarding adverse events for medical review.
Comprehensively worked with company registries and serious advent reports.
Functioned as co-project leader for EB2 and documentation projects.
Conducted quality control of other member of the team’s work and triage of cases.
Education:
Coursework in Computer Science
Delaware county community college, MEDIA, Pennsylvania
Affiliations:
National Association for Healthcare Quality
Drug Information Association
American Association of Managed Care Nurses
Skills:
Operational Leadership | Project Management | Process Optimization | Quality Assurance
Multichannel Communication | Business Development | Safety and Regulatory Compliance
Product Requirements Administration | Strategic Planning and Implementation
Additional Information:
Clinical Experience:
TMCA/NOVAEON, Malvern, PA
Telephonic Nurse Case Manager
Leader Nursing Home/Manor Care, King of Prussia, PA
Pro re nata (PRN) Floor Nurse
Delaware County Memorial Hospital, Lansdowne, PA
Nurse Assistant/Orderly
License:
Licensed Practical Nurse—State of Pennsylvania (Valid Until: Jun 2018)
Professional Development:
American Board of Managed Care Nurses—Certification in Managed Care Nursing (CMCN)
Cognos 8 Business Intelligence Report Authoring I and II
Candidate Contact Information:
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