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Athar Yaqoob

Pharmacovigilance Leader

Senior Medical Director, Medical Safety & Pharmacovigilance – Post Market Safety at Intercept Pharmaceuticals

Franklin Park, New Jersey

Section title

Athar Yaqoob's Email Addresses & Phone Numbers

Athar Yaqoob's Work Experience

Novartis Pharmaceuticals

Pharmacovigilance Leader

February 2008 to December 2009

East Hanover NJ

Intercept Pharmaceuticals

Senior Medical Director, Medical Safety & Pharmacovigilance – Post Market Safety

New York, United States

Syneos Health (Previously INC Research/inVentiv Health)

Director Safety Physician

September 2018 to October 2019

Home Based

Athar Yaqoob's Education

Quaid-e-Azam Medical College Pakistan

Doctor of Medicine (MD), Medicine

About Athar Yaqoob's Current Company

Novartis Pharmaceuticals

Performs pharmacovigilance activities for all assigned Novartis projects or products including identifying and analyzing safety signals based on a comprehensive evaluation of postmarketing data and Serious Adverse Events (SAEs) from clinical trials.

About Athar Yaqoob

📖 Summary

Pharmacovigilance Leader @ Novartis Pharmaceuticals Performs pharmacovigilance activities for all assigned Novartis projects or products including identifying and analyzing safety signals based on a comprehensive evaluation of postmarketing data and Serious Adverse Events (SAEs) from clinical trials. From February 2008 to December 2009 (1 year 11 months) East Hanover NJSenior Medical Director, Medical Safety & Pharmacovigilance – Post Market Safety @ Intercept Pharmaceuticals Contributes to the preparation of, reviews, and approves aggregate safety reports required by health authorities such as, Periodic Benefit-Risk Evaluation Reports (PBRER), US Periodic Adverse Drug Experience Report (PADER), etc. Manages compliance with standard operating procedures, regulatory, safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA) etc. for the reporting of adverse events to Regulatory AuthoritiesRepresents Medical Safety & Pharmacovigilance in communications with Health and Regulatory AuthoritiesLeads signal detection activities, authors signal analysis reports and provides periodic benefit-risk assessment reports. This includes the investigation and review of emerging safety data from various sources including individual clinical trial AE/SAE case reports, spontaneous Adverse Drug Reaction (ADR) reports from published literature, aggregate reports, toxicology reports, non-clinical studies, and other sourcesServes as the Medical Safety & Pharmacovigilance Lead for designated indications or drug portfolio(s) including providing after hours coverage for urgent/emergent medical queries related to clinical study conduct and patient safety.Provides oversight over the monitoring of clinical trial safety and monitors site compliance with protocol-specified measures intended to ensure the safety of subjects.Authors, reviews and provides input and approval for drug-safety related regulatory reports and clinical study documents including Clinical Study Protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), MedDRA coding of AEs, product package labeling, Company Core Safety Information (CCSI)Represents Medical Safety & Pharmacovigilance at independent Data Safety Monitoring Committee meetings Contributes to regulatory filings (including NDAs/MAAs) and responses as needed New York, United StatesDirector Safety Physician @ Syneos Health (Previously INC Research/inVentiv Health) • Writes safety section, including benefit risk assessment of all aggregate safety reports such as Periodic Drug Safety Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), DSUR/IND Annual reports and line listings of Suspected Unexpected Serious Adverse Reactions (SUSARs) for regulatory submission. • Provides product safety training to internal employees and external contractors / vendors as needed.• Participates in investigators’ meetings to provide training on adverse events reporting as required.• Prepares and may present product safety issues at meetings, both internal and external.• Authors/reviews relevant sections of all aggregate safety reports and ensures the overall quality of documents.• Assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety.• Responsible for responses to queries from regulatory authorities or health care professionals on safety issues and any legal queries and requests involving safety issues. From September 2018 to October 2019 (1 year 2 months) Home BasedMedical Director Pharmacovigilance and Medical Affairs @ PRA Health Sciences • Provides medical expertise on clinical drug development throughout life-cycle of compound. • Supports study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan, and other study material. • Provides continuous medical monitoring during study conduct, answers site questions on inclusion/exclusion criteria or other protocol questions, evaluates and assesses SAEs and AEs, reviews laboratory and other safety parameters, reviews patient profiles, reviews coded terms for medical history, concomitant medications, adverse events, and provides medical expertise to project teams during life-cycle of study. • Provides therapeutic training relevant to specific study to the project team. Attends and/or presents at investigator, internal and external project team meetings.• Contributes to discussions with health authorities, Ethics Committees, investigators, opinion leaders, internal and external clients.• Provides benefit/risk evaluations and drug safety expertise for drugs, diagnostics, and devices in development and during market authorization: From March 2017 to November 2017 (9 months) Raleigh, NCMedical Director Pharmacovigilance @ Pearl Therapeutics Lead or participate as members of Pharmacovigilance matrix-teams and other product teams.Provide oversight and key input for review of new or on-going safety documents that ensure compliance with domestic and international regulatory requirement such as Investigator Brochures, protocols, clinical study reports, ICF etc.Review of submissions to ensure procedural compliance and to assess the medical safety content for accuracy Manage I Lead and contribute to aggregate safety reports including Periodic Benefit Risk Evaluation Report (PBRER), Investigational New Drug (IND),New Drug Application (NDA),Developmental Safety Update Report (DSUR) and other periodic reportsContributor in the creation of risk management plans {RMP) as well as the implementation of risk management strategies Contribution and preparation of tables of expected events for Investigator Brochures (IB),Summary of Product Characteristics (SmPC),Package Insert (PI) and other label updatesCollaborates with other departments to ensure appropriate collection and handling of safety data From March 2015 to October 2016 (1 year 8 months) Morristown, New JerseyDrug Safety Physician @ CSL Behring Focus will be trials with the CSL developmental product CSL112 (developed for use in patients with ACS for the reduction in risk of recurrent cardiovascular events via the action of ApoA-I). From January 2014 to March 2015 (1 year 3 months) King of Prussia PADrug Safety Physician @ Boehringer Ingelheim Responsible for assessing individual clinical trial and spontaneous case reports for determining regulatory responsibilities Assessing seriousness, expectedness and comparing causality and quering for additional medical information needed to understand the event and determine causality Writing individual case assessments and interpreting aggregate safety data for periodic reports From March 2012 to September 2013 (1 year 7 months) Danbury CTDrug Safety Physician @ Daiichi Sankyo Responsible for carrying out pharmacovigilance activities on a product or group of products, including single case processing, aggregate reporting, signal detection and evaluation of PV database.  Contribute to the benefit risk evaluation and to safety risk management.  Support the on-going safety needs of both clinical development and post marketed products. From January 2010 to December 2011 (2 years) Edison NJ


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Frequently Asked Questions about Athar Yaqoob

What company does Athar Yaqoob work for?

Athar Yaqoob works for Novartis Pharmaceuticals


What is Athar Yaqoob's role at Novartis Pharmaceuticals?

Athar Yaqoob is Pharmacovigilance Leader


What is Athar Yaqoob's personal email address?

Athar Yaqoob's personal email address is a****[email protected]


What is Athar Yaqoob's business email address?

Athar Yaqoob's business email addresses are not available


What is Athar Yaqoob's Phone Number?

Athar Yaqoob's phone (201) ***-*775


What industry does Athar Yaqoob work in?

Athar Yaqoob works in the Pharmaceuticals industry.


Who are Athar Yaqoob's colleagues?

Athar Yaqoob's colleagues are Alex Brock, George MBA, Dannah Guest, Jennifer Kelly, Kazuyuki Suzuki, Saki Kawachi, Junko Sizemore, Kazuhiro Yamazaki, Aaron Wilson, and Sirisha Mareddy


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Athar Yaqoob's Personality Type

Extraversion (E), Intuition (N), Feeling (F), Judging (J)

Average Tenure

1 year(s), 5 month(s)

Athar Yaqoob's Willingness to Change Jobs

Unlikely

Likely

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