Professional Summary:

I am Pharmaceutical physician/subject matter expert with 11 years of core Pharmacovigilance experience (end to end process) with known expertise to set up Pharmacovigilance and medical writing functions, advanced knowledge on ArisG, Argus, Empirica tool and several Clinical trial databases. I am experienced in handling Health Authority queries and multiple Inspections (FDA, MHRA, and Health authorities of Emerging markets) and audits (License partner, client, Internal/PVQA).

ACADEMIC CHRONOLOGY:

MBBS

Rangaraya Medical College, Kakinada

2001-2007

DGO (Diploma in Gynecology and Obstetrics)

Andhra Medical College, Vishakhapatnam

2007-2009

●Registered medical practitioner, Indian Medical council (IMC)

●Member of Federation of Obstetrics and Gynecological societies of India(FOGSI)

PROFESSIONAL EXPERIENCE:

1.Head Pharmacovigilance-India, ROW region (Director), Dr. Reddy’s Laboratories from 01-04-2019 till date

●Pharmacovigilance officer in charge (24/7) for responding to queries from Health authorities, License partners

●Oversight of all regional Pharmacovigilance activities (post marketing, clinical trial projects for drugs and medical devices) in line with EMA, FDA, MHRA, GCP, GVP and other latest Health authority regulations

●Monitoring Risk benefit analysis of all MAH products through ICSRs (and Clinical trial SAEs), Aggregate reports (PSUR, PBRER, DSUR PADER), RMPs, Clinical expert statements/overviews, Signal detection activities (Empirica, EVDAS)

●Review of Clinical trial documents including protocols, MMP/SMP, Interim analysis report, CSR, Annual reports, Safety flow charts etc

●Review and sign off of Health Hazard assessment reports

●Supporting QPPV for maintenance and updation of PMSF, Additional risk minimization activities, cost centre activities, leading SMT/Product safety committee/leadership meetings

●Project management and keeping oversight of all vendors/service providers, affiliates and license partners

●PV database management (validation, upgradation)

●Initiation, updation and signing off SDEAs, inputs in Commercial/Quality agreements

●Development of Pharmacovigilance processes and procedures; responsible for robust company QMS (including policies, SOPs)

●Coordinating with ancillary departments (RA, QA, CT, Medico Regulatory, Finance, Marketing, Business development, Medical affairs, Medico regulatory, Legal) and supporting for Pharmacovigilance related queries

●Subject matter expert handling Health Authority Inspections and Audits and first point of contact for queries from Health Authorities and license partners

●Annual budgeting, resource management and forecasting

●Recruitment, training and managing local Pharmacovigilance responsible persons/PRP/NRPs

●Monitoring KPI targets of all team members, affiliates, vendors

Successfully implemented cost cutting for additional Pharmacovigilance activities, vendor expenses in FY2019

Associate Director Pharmacovigilance Dr Reddys Laboratories from 17-11-2018 till 31-03-2019

●Monitoring Risk benefit analysis of all MAH products through Aggregate reports, RMPs, Signal detection activities (Empirica, EVDAS)

●Supervision of deliverables: daily, monthly, annual- to different Health authorities, License Partners, and stakeholders.

●Annual budgeting, resource management and forecasting

●Pharmacovigilance officer in charge

●Conducting and Monitoring Pharmacovigilance Annual trainings for all ancillary departments

●Coordinating with ancillary departments

●Maintenance of robust Quality Management system

●Initiation, updation and signing off SDEAs, SOPs, Working practices

2. Team Manager (Aggregate Reports and Empirica Signal Detection) Cognizant Technology Solutions from 12-05-2016 till 16-11-2018

●Monitoring benefit risk assessment of the products through review of the Periodic safety update reports (PSUR/PBRER)

●Signals detection with Empirica tool (representing at SMT/SIGDET meetings) integration with Eudravigilance

●Performing review/ analysis of Safety sections/Safety topics of aggregate reports and Clinical overviews on Signals and Safety issues; Addressing Health Authority comments and recommendations

●Creation and management of action items (SMaRT topics) of products in Empirica tool

●Coordinating with client for timely discussion of Signals, Safety issues in PSUR drafting and providing resolution; providing medical assessment and comments on client queries

●Subject matter expert handling Audits and Inspections

3.Medical Operations Leader (Manager), Clinical Research Services, Parexel International from 22-06-2015 till 29-04-2016

●Oversight of Medical Services projects/ project management including Pharmacovigilance, Medical writing, and Clinical Trials, medical monitoring, clinical endpoint adjudication, and data safety monitoring committee management

●Providing strategic input in the planning and setup of PV projects, including scope, costing, budgeting, resourcing, workflow and process design and analysis; responsible for quality of projects; responsible for adequate resource planning and allocation through project tool

●Responsible for all deliverables including (ADRs), conduct and review of literature searches, preparation, and submission of PSUR/DSURs, clinical trial medical monitoring – review of endpoints, lab alerts and waivers and ensuring client satisfaction

●Performing Monthly revenue recognition and forecast activities on tool

●Providing training and mentoring to other, less experienced MOLs and Drug Safety Staff

●Providing support in internal and external audits and inspections and ensuring that corrective actions are implemented as appropriate for all assigned projects

4. Clinical and Medical Safety Lead (Clinical and Medical Affairs), MSN Labs from 09-10-2013 till 13-06-2015

Pharmacovigilance and Medical Writing

●Setting up of Pharmacovigilance and Medical Writing departments: Preparation of PSMF, DDPS, SPS and Pharmacovigilance SOPs & forms.

●Drafting and review of Aggregate reports (PSURs and PBRERs), Risk Management Plans, ACOs, Clinical expert statements, Impact analysis reports, Signal detection reports, and Safety Data Exchange Agreements/ SDEAs

●Metrics monitoring for ongoing Pharmacovigilance activities: ICSRs, PSURs, RMPs, PBRERs, ACOs, CES, Signal detection reports

●Oversight of vendors and third party service providers

●Responsible for handling Queries from Health Authorities, license partners and market complaints

●Subject matter expert for handling Audits and Inspections

●Review and Updation of Company Product label/SPC

●Providing training on Pharmacovigilance to ancillary departments including Marketing/ Sales team/ RA departments and to affiliates outside India

Clinical Trials

●Review of documents for New Drug Approvals and Assisting in NDAC (New Drug Approval committee) meetings at DCGI office, New Delhi

●Medical inputs in Product pipeline selection, preparation of documents for Fast track approvals

●Preparation of the company Clinical Trial SOPs and CT supporting documents (Executive summaries, ppts, Brief Information on Clinical Trial protocol); review of Clinical trial protocols, Clinical Study reports, Annual reports, Interim analysis reports

●Compilation of Cover letters, CT Waiver Letters and other Clinical trial and Pharmacovigilance related documents to DCGI and other Health Authorities

●Clinical trial monitoring and coordination with different CROs, service providers for ongoing and planned CT studies

5. Pharmacovigilance Expert in Integrated Medical Safety-Oncology, Novartis from 29-06-2011 till 13-09-2013

●Responsible for Medical Review of ICSRS, PSUR/PBRERs, Addendum reports, DSURs, Risk Management Plans

●Responsible for Monthly Signal Detection activities of 6 Oncology Products and for detecting new Topics

●Preparation of Clinical Expert Statements, Clinical overviews, Impact Analysis documents; review of Clinical Study Reports

●Supporting CAPA activity; supporting Data Management teams in Reconciliation reports

●Preparation of supporting documents for CDS update: supported Label updation of Oncology products; Drafting/updation of SOPs, working practices

●Representing Projects in MSRB, SIGDET, SMT and other concerned meetings

●Senior medic responsible for training and mentoring processing teams worldwide, New joiners, vendors and oversight through monthly metrics

6. Medical Reviewer and Pharmacovigilance Investigator, Aurobindo Pharma Limited from 17th Nov 2009 to 02-May-2011

Performing Medical review of ICSRs, PSURs, PADERs, Risk Management plans, handling Signal detection; Handling of market / consumer complaints and review of Monthly compliance reports; Providing guidance for the preparation of CAPAs; providing response to Health Authority queries and requests for safety information from the local RPPs; supporting Health authority Inspections and internal pre-audits, audits; providing training to the new recruits of GPVD team.

TECHNICAL SKILLS:

●MS Office, ARISg, Argus, Empirica Signal detection, VCAS( End point Adjudication),

●RAVE, Clin ops (clinical trials), MPOR (scope), Multiple budget & Forecast tools (Harmony)

●Microsoft office, excel, powerpoint

AUDITS:

Aurobindo Pharma Ltd.: Supported MHRA Inspection, 2010

Novartis: Supported internal audits, USFDA Inspection in 2012

MSN labs: Handled internal audits, inspections from Ukraine, Kazakhstan in 2013

Parexel: Handled Client audits in 2015

Cognizant: Handled Client audits in 2017, 2018

Dr Reddy’s Laboratories: Handled Internal Audit, License partner audits, supported for FDA, Health Canada, Chile & MHRA Inspections in 2018, 2019

Awards:

●Over and Above Performer of the Year Award, 2012, Novartis-IMS Oncology

●Best performer award with Deferred Cash Prize of 2.5 Lakh, in 2012, Novartis

●Best Mentor Award for Training Medical Reviewers, in 2013, Novartis.

Respected Sir/Madam

I am DrSultana from India and I am interested to apply for position of QPPV in your esteemed organization.

Presently I am working as Head Pharmacovigilance (India, ROW) at Dr Reddy’s Laboratories, Hyderabad, India and am also the Pharmacovigilance officer in charge for India.

As specified in the job profile, the requirement is for a subject matter expert with experience in multiple fields including Pharmacovigilance, Clinical trials, Medical and Regulatory affairs; also with an eye for precise deliverables on par with Health authority recommendations.

My profile would be a good match as I am Gynaecologist by education, experienced in end to end Pharmacovigilance (11 years), Clinical trials management and medical writing. I had also established Pharmacovigilance and medical writing departments for a generic Pharma company based in India. I am experienced in supporting Regulatory affairs team through CTD, ACTD module dossier preparation, updation and review of product labels.

In my 11 years of extensive career as subject matter expert,

●I have prepared multiple PV SOPs, working instructions, Forms and overseen database operations

●Drafted company PSMF/DDPS, SDEAs

●Handled multiple Health authority Inspections (MHRA, FDA, Health Canada) & Audits (client/license partner)

●Monitored the risk benefit profile of products through review of single cases/ICSRs, aggregate reports (PSUR, PADER, PBRER, DSUR), risk management (RMP REMS), Clinical overviews, Addendums, and Signal detection activities and ensures timely submission of all deliverables to concerned Health authorities

●I have experience in Clinical trial team handling (phase II, III, Clinical End point adjudication), trial monitoring, drafting and review of CT documents including protocols, IB, MMP, CSR; experienced in interacting with KOLs etc; providing dossier preparation support to Regulatory Affairs team

●As subject matter expert have been driving upgradation of company procedures in line with GVP modules and updated Health authority guidance and regulations

Achievements

●Experienced in setting up Pharmacovigilance, medical writing units

●Initiated PSMF updation for major markets and successfully faced Inspection of the same

●Initiated Quality and compliance assessment through Risk Categorization matrix for all affiliates and vendors; achieved improvised KPI targets

●Pioneered and rolled out basic Pharmacovigilance awareness training for all ancillary departments, affiliates, license partners and vendors

●Coordinated for establishment of Global Social media team : guidance for drafting Sops, working instructions, establishing MI/PV/QA/Query database, channels of communication from call centers to central PV team and processes of follow up

●Lead establishment of internal PVQA team and preparation of risk categorization for all license partners, vendors and affiliates

●Performed effective vendor, CRO selection for Post marketing and Clinical trial projects

I am very enthusiastic to join and to be a part of your esteemed organization. Looking forward to your reply and further discussion.

Yours sincerely

Dr Hussain Sultana MBBS DGO

LinkedIn link: https://www.linkedin.com/in/dr-hussain-sultana-gottipalla-4b5b6831

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