MANMIT KAUR

Phone: +614******** Email: acrzp7@r.postjobfree.com

OBJECTIVE

Experienced Pharmacovigilance (PV) professional looking to pursue opportunities that leverage skills and expertise within the pharma industry. I value teamwork, leadership and attention to detail and try to continuously challenge myself to develop further. As a diligent, goals-driven, and team-spirited individual, I am dedicated to creating value for my employer and delivering quality and outstanding services to clients. KEY HIGHLIGHTS & COMPETENCIES

o Pharmacovigilance Skills – More than 7 years of experience in drug safety, case processing, problem formulation, data interpretation, data presentation, adverse event assessment and regulatory reporting o Therapeutic Focus – Diabetes, Cardiovascular, Urology, Oncology, Neuroscience, Endocrinology, Autoimmunity and Musculoskeletal

o Client Facing Skills – Experienced in working with clients to process, review and disseminate information to meet the customer needs and requirements

o Communication Skills – Ability to communicate with all levels of senior management, regulators, business partners, healthcare professionals and customers

o Project Management Skills – Delivered exceptional vendor management experience exhibiting strong project management skills that helped deliver projects on time o Other Skills – Working knowledge of ICH-GCP guidelines and OH&S policies and procedures o Advanced user of Excel, PowerPoint, Word and ArgusTM Safety Systems (Pharma specific) EDUCATION/PROFESSIONAL CERTIFICATION

UNIVERSITY OF TECHNOLOGY SYDNEY, BACHELOR OF SCIENCE (BIOMEDICINE) 2004 –2007 INTRODUCTION TO PHARMACOVIGILANCE (ARCS AUSTRALIA) 2009 MANAGING PATIENT SUPPORT PROGRAMS (ARCS AUSTRALIA) 2013 TGA RISK MANAGEMENT PLAN WORKSHOP (TGA/ARCS AUSTRALIA) 2015 PROJECT MANAGEMENT FUNDAMENTALS (PM PARTNERS) 2015 PROFESSIONAL EXPERIENCE

ELI LILLY AUSTRALIA PTY LIMITED Aug/2013-Present

Senior Pharmacovigilance Associate, Global Patient Safety Sydney, Australia o Liaised with Global Patient Safety (GPS) and case management departments to ensure accurate evaluation of safety information for cases through the collection, processing and follow up of case data o Monitored and assessed responsible countries’ PV regulations to provide updates to global GPS o Structured, updated and implemented local procedures to ensure these were aligned with GPS global procedures and national requirements

o Interacted with Health Authority (HA) officials, internal and external stakeholders to exchange relevant patient safety information, provide timely PV expertise and support audits and corrective actions o Developed and updated training materials for PV and delivered training to external stakeholders (e.g. business alliance partners, PSP vendors) on relevant GPS procedures o Led safety transition activities for drug acquired by other companies (Actos to Takeda and Byetta to Bristol- Myers Squibb). This involved the transfer of more than 2,000 cases and source documentation to the acquiring companies

o Led the affiliate GPS/Regulatory audits to ensure that global procedures are implemented, corporate policies are followed while agreements with alliance partners/vendors meets corporate standards o Participated in cross functional teams to provide input on safety activities for products in the pipeline

(diabetes and psoriasis) particularly on implementation of Patient Support Programs (PSP) and modules Achievements:

o Implemented a global application Adverse Events Product Complaints (AEPC) iForm enabling sales representatives to enter any adverse events into a simple form. Achieved usage rates of 80% amongst sales representatives which helped reduce time and effort in creating quality reports and adding value to the interactions between sales representatives, safety professionals and physicians ELI LILLY AUSTRALIA PTY LIMITED Jan/2011-Jul/2013

Product Safety Associate, Global Patient Safety Sydney, Australia o Performed initial assessment of Adverse Event (AE) and Serious Adverse Event (SAE) cases/reports according to local/global regulations as well as corporate procedures o Translated and transcribed AE and SAE assessments into the global database and followed up with relevant stakeholders including contractual partners, other pharma companies and data entry centers o Prepared and submitted individual case safety reports (ICSR) to applicable health authorities (TGA, Medsafe), participated in ICSR compliance activities and undertook corrective action for late reporting o Conducted reconciliation of AE reports received from other operating units (including Designated Point of Contact, Medical Information) and contractual business partners (e.g. Boehringer Ingelheim, GSK, Aspen, Alphapharm, Atlantis Healthcare and Aesir Health)

o Identified and communicated potential safety issues and assisted in product safety issues investigation o Provided PV expertise to other operating units and assisted in the training to PV and customer facing staff Achievements:

o Achieved timely expedited reporting and case processing by being the single point of contact for both internal and external customers. Demonstrated leadership and learning agility with the ability to work unsupervised

o Influenced Medical Quality, GPS to update the Case Entry procedure. Reduced duplication and improved efficiency by linking unique Adverse Event ID’s for PSP adverse events as part of a global patient safety initiative

ELI LILLY AUSTRALIA PTY LIMITED Aug/2008-Dec/2010

Product Safety Graduate, Global Patient Safety Sydney, Australia o Collected, processed, documented, reported and followed-up on AE reports concerning all products from clinical trials, post-marketing studies (PMS), spontaneous reports (SRs) and commercial programs o Addressed safety issues raised by patients, healthcare professionals and customers through cross functional collaboration with Medical Information and Product Quality departments o Led training initiatives for internal business functions and external third parties on adverse event reporting requirements

o Involved in launch activities for Cymbalta and worked closely with the business alliance partner – Boehringer Ingelheim to manage high volume of Cymbalta cases

o Reviewed and implemented regulatory changes in Australia and New Zealand o Submitted safety reports to the health authority, TGA, and New Zealand CARM and Medsafe Achievements:

o Acknowledged and praised by Regulatory Affairs Manager and Senior Associate for being a quick learner. Completed case processing activities for clinical trials and spontaneous cases including timely submission of expedited reports to Health Authorities for Australia (TGA) and New Zealand (Medsafe/CARM) within 3 months of starting the role

o Received “Excellent Customer Service” award for on-time response to patients/HCP o Delivered PV training to internal employees and business alliance partners

ADDITIONAL INFORMATION

o 2014 – National Institute of Dramatic Art (Sydney, Australia), Musical Theatre course o Running, reading, and travelling

o Eligible to work in the U.S.

o References available upon request

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