Director Pharmacovigilance

AZITA EBTAHAJ

**** * ******** ******, *** ***, Los Angeles, CA 90025 M: 818-***-**** ********@*****.***

British Citizen and US Permanent Resident (Green card holder)

SUMMARY

State registered biomedical scientist with 18 years of experience in drug safety/clinical operations and some regulatory projects within pharmaceutical and biotech companies globally. Proven success in modeling and development of safety databases, managing internal / external projects with vendors as well as management of staff and training individuals in performance improvement projects for safety and clinical. High achiever motivated by delivering results for corporate and personal objectives. Known for enthusiastic energy, flexibility in working with diverse audiences and an upbeat sense of humor. Always reaches goals with success.

Core Competencies

Training and development

Business development

Change management

Client engagement

Executive interface ability

Extensive safety database knowledge

Clinical and post marketing knowledge

EU & FDA regulatory submission knowledge

Insight into many therapeutic areas including oncology, inflammation, and general medicine.

PROFESSIONAL EXPERIENCE

CONSULTANT /AMGEN-GLOBAL PATIENT SAFETY MAY 2022-CURRENT

Provide proactive safety surveillance across immuno-oncology therapeutic area working early development products and all clinical development.

Safety signal Management and detection for immune-oncology products

Rave, Argus, Right find, Spotfire analysis and platforms used.

Assisting the GSO will all safety documents and presentation of data to executive teams

Communicate and attend meetings with global development, clinical and regulatory executive teams.

REGENERON

CONSULTANT /AD/DIRECTOR SAFETY SCIENTIST - JUNE 2021- MAY 2022

Provide proactive safety surveillance across REGEN-COV antibody treatment and all clinical development clinical trials including pediatric patients

Lead of EUA safety analysis

BLA safety queries and answers for MHRA/EMA and FDA

Safety signal analysis

Author FDA monthly safety documents

Presenting safety data to upper management for COVID-19 treatments EUA and clinical studies.

Strategy, support, and creation of new safety platform within Regeneron for SRP Safety Reporting Platform.

GENENTECH-ROCHE MAY 2020-JUNE 2021

CONSULTANT /ASSOCIATE DIRECTOR SAFETY SCIENTIST (PORTFOLIO CLINICAL SAFETY)

Provide proactive safety surveillance across TECENTRIQ (ATEZOLIZUMAB) ongoing clinical trials

Support development, author and execution of Risk Management Plans for Atezolizumab

Support the creation and execution of the Risk Implementation Plans based on HCP Brochure and Patient Alert Cards (PAC)

Safety lead point of contact for two multi-cohort ten arm studies (TAPISTRY AND MYTACTIC) -both tumor agnostic clinical trials Europe and in US.

Safety Author for Health Authority Questions and Answers per cohort arms in clinical studies.

Spotfire training and use of system.

Providing Safety Support for RMP updates on other therapy areas

Clinical Meetings-Cross functional meetings study team leads and interaction with other departments

Safety Presentations for Investigator meetings live – speaker for clinical safety.

GREENWICH BIOSCIENCES MAY 2019- MAY 2020

CONSULTANT ASSOCIATE DIRECTOR GLOBAL PHARMACOVIGILENCE

Provide proactive safety surveillance across lifecycle of CBD and THC products for ongoing clinical trial data in support of rare childhood epilepsy, support development and execution of Risk Management Plans, Risk Assessment, and Risk communications pre/post marketing, in addition to responsibilities listed below

Head of Signal Evaluation and leader of safety management meetings for CBD therapies. Update of Core data sheets, PADER, PBERS, PSUR review. Worked closely with medical writers.

Safety lead of Schizophrenia IND

Safety Lead of RETTS IND

Safety Lead for Pediatric Investigator studies

Provide safety analysis and input of aggregate data reports.

Audit leads

Training of Marketing and medical information Vendors for Pharmacovigilance

Operational management oversight with the team in UK Cambridge.

Present to the Corporate Safety Board

Argus Databases use and PVQ analysis.

PUMA BIOTECHNOLOGY

Senior Manager of Pharmacovigilance

Senior Manager, Global Pharmacovigilance Dec 2016-MAR 2019

Provide proactive safety surveillance across lifecycle of Puma products, support development and execution of Risk Management Plans, Risk Assessment, and Risk communications pre/post marketing, in addition to responsibilities listed below.

Perform periodic aggregate safety data review according to signal detection strategy and escalate possible safety issues to VP of Pharmacovigilance. Involved in creation / draft of PADER/PSUR reports.

Management of 40 clinical and PV contracts, creating and finalizing statement of work documents with accounting departments.

Completing change in scope work orders and managing the accurate financial running of all PV studies.

Responsible for financial system- Oracle to enter PV departmental forecasts on a quarterly basis. Actuals vs Variance analysis for accounting and finance.

Provide safety data analysis for Safety Review Committee (SRC).

Input for RMP updates and PSMF activities- for FDA Approval and EU.

Involved in commercial activities for Puma-Medical Affairs and Marketing meetings necessary for monitoring safety during commercial phase.

Working with Parexel, Pro-Pharma, PPD vendors, oversight of vendor management set up of contract agreements.

Manager, Global Pharmacovigilance June 2014-Dec 2016

Perform periodic aggregate safety data review according to a signal detection strategy and escalate possible safety issues to the VP of Pharmacovigilance.

Generate periodic aggregate safety reports for assigned product(s)

Monitor medical and scientific literature for published articles relevant to the safety profile for assigned products(s).

Define search criteria, run validation databases searches and analyze data for safety signal detection in consultation with the VP and clinical monitor.

Plans perform analysis in support of response to regulatory, EC/IRBs and investigator or ad Hoc inquiries regarding safety issues.

Support development and execution of risk management plans, risk assessment, and risk communications.

Conduct safety data analysis in support of developing and updating safety sections of regulatory documents, informed consent, annual reports, company core data sheets and product labels.

Provide support of developing and updating investigator brochure and study protocols

Provide safety data analysis for the Safety Review Committee (SRC)

Manage the day-to-day aspects of the CRO’s

Lead efforts to improve processes and increase work efficiency applicable to safety surveillance

Remain in compliance with active puma standards and procedures.

AMGEN (USA)

Senior Associate (GRASS) Global Regulatory Affairs & Safety Surveillance Jan 2012 to Dec 2013

Pregnancy team lead for Amgen US and local Amgen offices in EU.

Main responsibilities were to triage, processing and completion of pregnancy reports in ARGUS for all Amgen products. Some 400 patients were enrolled and monitored for safety compliance. Designed and implemented an excel database to monitor patients accurately for eight years. All patients were followed up via phone calls for due diligence and in line with the FDA compliance guidelines. Regular coordination and meeting with the pregnancy team physicians for update on reports and outcomes. Responding to FDA inquiries, Power point presentation to safety group global regulatory leaders on operational updates to e-Manuals and SOPs.

Training external contractors to assist compilation of pregnancy patient database.

Leadership skills: Successfully managed and directed staff responsible for preparation of safety reports

Remote management of 10 staff, part of vendor team.

Prepared training material in the form of PowerPoint presentation for global safety training forums and was in charge of training team members.

Managed the workload and assigned work to the team members.

Appraisal and review of the safety cases completed by team members, trouble shooting and correction.

Gave advise to team members on corrections needed and guided team members in order to develop their working practices.

AMGEN (USA) operations safety

Senior Associate safety surveillance Jan 2006 to Jan 2012

Provided proactive safety surveillance across the lifecycle of Amgen products and supported the safety surveillance processes for Amgen products by the receipt, evaluation and regulatory reporting on individual case reports.

Assisted with safety product launch from early development clinical trial phase to post market safety monitoring across all Amgen products to assure compliance with corporate partners and regulatory authorities globally. Enbrel, Neupogen, Neulasta, Aranesp, Epogen, N plate and current new launch of Denosumab.

Managed and represented safety data within Amgen’s central safety database covering both pre- and post-market products enabling regulatory compliance and Amgen pharmacovigilance.

Provided technical (clinical and adverse event reporting) support to case management team and vendor management.

Developed methods and techniques based on project objectives. Worked with the senior management for a period of 3 months, on ARGUS safety database development. I was involved in script testing, writing and defect analysis of ARGUS System including training of staff for ARGUS GO-LIVE.

Managing CRO Vendors in India with outsourcing of safety. Involved in training for triage of safety data reports, quality review of safety data and preparation of reports for regulatory submission.

Johnson & Johnson- Drug Safety (Medical and Regulatory Department) (UK) Jan2005 to July 2005

Associate Benefit Risk Management

Worked as a consultant for safety team on Remicade (infliximab).

Pfizer Drug Safety (Medical and Regulatory Department) (UK)

Drug Safety Officer Dec 2003 to Dec 2004

Responsible for the collection, assessment and reporting of adverse events and serious adverse events within regulatory reporting timelines. Entering Clinical and spontaneous cases into local tracking database-Prometeo. Covering Cardiovascular and Central Nervous System Pfizer product therapies.

Report writing and reconciliation of spontaneous and clinical trial reports.

Generating queries letters and follow-up letters for case completion and reporting back to clinical sites.

Reporting of clinical trials to Worldwide Safety (Pfizer New York)

Clinical trials reports worked on ASCOT, LEAD, Geodon, and Atorvastatin studies.

ASCOT clinical trials, acting as a coordinator between clinical sites and the drug safety department. Liaison with Medicines and Healthcare Products Regulatory Agency (MHRA-UK).

Contributed significantly in creating a new drug safety database (Prometeo) for Pfizer and facilitate and contributed towards Pfizer having a MHRA Audit.

Novartis Pharmaceuticals (UK)

Clinical Safety Assistant May 2003 to Dec 2003

Working on several projects and coordinating closely with the “Clinical Safety Scientists” and “Medical Safety Experts”.

Interpretation of serious adverse event reports to ensure accurate and consistent data processing from source documents.

Preparing events’ narrative and summarizing the essential details of the clinical cases.

Assisting with compilation of the final regulatory forms. Adhering to GCP and ICH guidelines. Preparing follow up reports.

John Radcliffe Hospital (UK) – Biochemistry Department Trainee Biomedical Scientist

Biomedical Sciences MSc Aug 2001 to May 2003

Training for State (Board) Registration in Biochemistry. Valuable clinical experience in areas of Toxicology, Immunology, Automated and point of care testing. Working as a biomedical scientist in a biochemistry diagnostic laboratory. Knowledge of GCP, ICH, FDA and MHRA SOPs and guidance lines. Statistical analysis using Excel and Minitab.

EDUCATION & QUALIFICATIONS

John Radcliffe Teaching Hospital, Oxford, UK

State Board- Registered Biomedical Scientist-Institute of Biomedical Scientist Master Science (IBMSc) Clinical Biochemistry training and completion- (2001-2003)

University of Brighton, School of Pharmacy and Biomolecular Sciences, Brighton, UK

Bachelor’s Degree with Honors (BSc) Biomedical Science (1998-2001).

King Alfred’s Sixth Form, Wantage, UK

Three Advanced Levels; Chemistry, Human Biology, Sociology- (1996-1998

(Pre-entry qualification for Biomed)

Warneford School, Highworth, UK

General Certificate of Secondary Education – 10 GCSE Passes (1991-1996)

TECHNICAL SKILLS

WORD, EXCEL, POWERPOINT, OUTLOOK. ARISg and ARGUS Databases knowledge. Darts (Pfizer Drug Safety database) PowerPoint (Advanced) Excel (Advanced) Prometeo (Pfizer Drug Safety local database), Spotfire training

ASSOCIATIONS

State registered: IBMS- Institute of biomedical master science

John Radcliffe teaching Hospital-Oxford

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