Rohini Priyadarshini

• A high energy driven professional with over 12 years of experience in Clinical Research-Pharmacovigilance with varied cross functional expertise.
• Managed the spectrum of activities including review, analysis, QC, method development and coordination with cross-functional departments.
• Managed Safety staff responsible for delivering services in Safety Operations under the guidance of senior management as an associate manager.
• Instrumental in taking a lead role in the QC activities of ICSRs, narrative projects for different type of safety cases including clinical trial cases, vaccines and mitigate any issues for timely submission.
• Manage and the execution of ICSR’s and PSUR’s for varied types of safety assessments thus ensuring the successful progress and completion of the tasks effectively meeting regulatory compliance.
• Exposure in managing administrative functions of department thereby attaining high quality output.
• Assigned Subject Matter Expert (SME) in project applications through the delivery of workshops, presentations and relevant trainings.
• Ensured compliance to quality and regulatory measures by maintenance of appropriate documentation/ records.
• Effective communicator with strong analytical, problem solving and team building abilities.

• Thesis during Post graduation, Quality Systems Practiced in Clinical laboratories under the guidance of Dr. Jayashree and Dr. Satish collected and analyzed data from various clinical laboratories from Hyderabad and Chennai Cities, May 2007, May 2007
• Study on Diabetes mellitus, Gained practical and technical knowledge in glucose estimation at Tapadia Diagnostic Labs, Hyderabad under the guidance of Dr.R.Tapadia, Nov 2004, Nov 2004
• Completed a certificate course in Biostatistics, 2003, 2004

• 21st Century Managers “Dare to succeed, Hyderabad
• Industrial visits to LEPRA (India), Hyderabad and National Institute of Virology, Pune, 2003, 2003

• MedDRA (medical dictionary for regulatory activities) - MedDRA site contact for Hyderabad site.
• Responsible for conducting trainings for both update and basic MedDRA versions. Conducted training for all associates at Hyderabad site for MedDRA update in Oct-Nov 2011.
• MAP (manual for Argus case processing): Core team member of MAP update team and was actively involved in MAP project to update and review few specific chapters like duplicate handling and search, product, case form activities along with Hyderabad team members and closely worked with Global colleagues.
• Therapeutic Area Coordinator for Cardiovascular & Metabolism Therapeutic Area and handled a team of 12 in year 2009.
• Involved in training new hires and mentoring new associates which enhanced ability to work closely as well as gain experience and also to get more familiarized with Argus conventions and to refer and learn MAP guidelines on regular basis. Selected for “Talent Acceleration Program (TAP)” of Novartis.
• TAP is a program that is held for period of 3-4 months which emphasizes on main topic areas like communication in cultural set up, teamwork and collaboration, self-awareness, the big picture to think and to work out of the box. Completed and received certificate in May 2011.
• Automation Management experience/Solution building. To develop an AI platform to process cases end to end with machine learning and data analytics capabilities. Solution creation involves defining domain objects- for processing documents those documents would be going through case management flow for the entire end to end process.
• Entity and attributes relationship while creating domain objects.
• Was involved in annotation to tag/label different kinds of documents to enable machine learning to develop golden data sets.

• Collaborated and worked with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
• Interacted and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third-party contractor, if applicable.
• Oversaw and developed, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements. Accomplished input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
• Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities and/or clinical operations in cooperation with other Country Organization Departments.
• Performed reconciliation with other departments (e.g. Medical Information, Quality Assurance and third-party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
• Performed QC review of completed individual safety reports. Completed data entry including writing of adverse event narrative and provide preliminary assessment of event seriousness and expectedness/listedness as per applicable Reference Safety Information.
• To generate adverse event queries, liaise with the medical reviewers/client to agree upon the queries, and send request for additional information to the sites/reporter. To get engaged with the Site Monitors to ensure follow up information is obtained from site effectively.
• Lead in the development of case management related Sops and Operating Guides. Evaluation and QC of ICSRs (Serious Adverse Event / Post Marketing Adverse Event) to ensure accurate and consistent data entry and processing from source documents, with emphasis on timeliness and quality.
• Authored the periodic safety update reports (PSUR); addendum reports (AR) and bridging reports (BD) in co- ordination with Medical Safety Physicians and Regulatory Associates.
• Triaging of literature cases for databasing or pass them on to the Team Manager for approval or rejection.
• Participate in cross-functional teams on safety matters/DS&E special projects relating to investigational and marketed drugs.
• Product Guidance Documents: Involved in authoring product guidance documents and trainings for drugs of Nervous system disorder franchise.
• Ensure support for and close-out of audits, corrective action plan, and investigation and Health Authority inspections. Ensured training and oversight of staff, as applicable.
• Periodic Safety Update Reports and Addendum Reports: PSURs authored include: Complex PSURs - 3 PSURs, Medium PSURs-3, Simple PSURs-6. ARs authored include: Complex AR - 3, Medium AR - 5, Simple - 10. Also involved in QCing of PSURs and ARs.

I hereby declare that the above mentioned information is true to the best of my knowledge and I bear the responsibility for the correctness of these particulars.

• Professional

· MedDRA (medical dictionary for regulatory activities) - MedDRA site contact for Hyderabad site.

· Responsible for conducting trainings for both update and basic MedDRA versions. Conducted training for all associates at Hyderabad site for MedDRA update in Oct-Nov 2011.

· MAP (manual for Argus case processing): Core team member of MAP update team and was actively involved in MAP project to update and review few specific chapters like duplicate handling and search, product, case form activities along with Hyderabad team members and closely worked with Global colleagues.

· Therapeutic Area Coordinator for Cardiovascular & Metabolism Therapeutic Area and handled a team of 12 in year 2009.

· Involved in training new hires and mentoring new associates which enhanced ability to work closely as well as gain experience and also to get more familiarized with Argus conventions and to refer and learn MAP guidelines on regular basis.

· Selected for “Talent Acceleration Program (TAP)” of Novartis. TAP is a program that is held for period of 3-4 months which emphasizes on main topic areas like communication in cultural set up, teamwork and collaboration, self-awareness, the big picture to think and to work out of the box. Completed and received certificate in May 2011.

• Academics

. Pursuing Product Management

. Thesis during Post graduation: Quality Systems Practiced in Clinical laboratories under the guidance of Dr. Jayashree and Dr. Satish collected and analyzed data from various clinical laboratories from Hyderabad and Chennai Cities -May 2007.

. Study on Diabetes mellitus: Gained practical and technical knowledge in glucose estimation at Tapadia Diagnostic Labs, Hyderabad under the guidance of Dr.R.Tapadia in Nov 2004.

. Completed a certificate course in Biostatistics in the year 2003-2004.