• Symogen
    Global Experts in Pharmacovigilance - Service Providers & Outsourcing
  • Pharmacovigilance
    Pharmacoepidemiology - Medical Writing - Regulatory Services.
  • Global Presence
    With Offices in the United Kingdom, United States and India

Experts in Pharmacovigilance...



Symogen is a niche service provider for all aspects of Pharmacovigilance, Pharmacoepidemiology, Medical Writing & Regulatory Services.

Established in 2007, our clients are large and midsize pharmaceutical and biotech companies.

Symogen has an impeccable reputation for excellent customer services and extremely ethical
and high quality of work under the leadership of Dr Pipasha Biswas.



Mission



Symogen believes in working together with our clients in an ethical and transparent manner to advance the science of proactive pharmacovigilance
to meet the regulatory demands. We give quality service to our clients, based on continuous innovation, high quality and total confidentiality.



Experience

More than 18 years of experience providing Pharmacovigilance and Pharmacoepidemiology services, our team of global experts include highly qualified, trained and experienced professionals from the corporate and academic world.

Quality

By understanding and improving operational processes; identifying customer requirements quickly and systematically; establishing valid and reliable service performance measures and measuring customer satisfaction.

Innovation

Research and innovation is an important part of Symogen business development process. We focus in several research projects to continually improve and enhance the quality of our services and to meet the high requirements of our customers.

Our Team


Symogen staff in Pharmacovigilance and Pharmacoepidemiology are experts, who include highly qualified, trained and experienced professionals
who have many years of experience in pharmaceutical companies and from academia in Europe, USA and India.



Dr. Susan Bews
Symogen Team
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Dr. Lynda Wilton
Symogen Team
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Dr Arun Kumar Biswas
Symogen Team
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Dr Pipasha Biswas
Symogen Team
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Dr.
Symogen Team
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Mr.
Symogen Team
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Mrs.
Symogen Team
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Mr. Pedro Berrio
Symogen Team
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  • "Excellent knowledge in pharmacovigilance especially in Signal Detection and Risk Management. Approachable and executes work meticulously, accurately and on time”Senior Safety Science Leader, Roche Pharma
  • "Deep understanding of safety risk management; is a real asset to companies needing pharmacovigilance support."President & CMO, Glenmark Pharmaceuticals
  • "Professionals with an abundance of pharmacovigilance experience used to produce quality work in a timely fashion. Symogen values success of the team and is genereous in sharing their experience, knowledge and time."Director, International PV, Eisai
  • Expert knowledge of PV, enthusiasm, leadership & excellent skills."Senior Pharmacovigilance Manager, Astellas Pharma

Our Services

ADR Case Processing , Reporting & Submissions 24/7/365: Drugs, Vaccines, Medical Device, Cosmetics & Nutritionals


  • Book in, Triaging & 24/7/365 Case Management Support
  • Data entry into validated electronic PV database
  • 100% Quality control of all ICSR including medical QC
  • Medical review and assessment, narrative writing, MedDRA coding
  • Product Quality Complaints Management
  • Reporting & Submissions: Electronic (E2B), Hard copy (CIOMS, MedWatch 3500A drug, etc.) to worldwide regulatory authorities


Literature Review, Search & Monitoring


  • Full text weekly searches from worldwide literatures
  • Ongoing, weekly literature monitoring for identification of ICSRs (Individual Case Safety Reports)
  • Active ingredient specific - alternative names/ Product specific search
  • Integration with case processing in safety database
  • Full text articles procurement and translation


Production, Generation & Submission of Aggregate Reports (PBRERs, PADERs, SBRs, ASRs & DSURs)


  • Production of Product Specific Line Listings
  • Complete authoring and production of PEBRERs, PADERs, SBRs, DSURs/Addendums/SBRs/Addendum to clinical Overview
  • Compliant Formats: ICH E2C, GVP Modules; US FDA CFR Part 314.80

Safety Data Exchange Agreement Management


  • Authoring and preparation of SDEAs customized per global regulatory requirements
  • Review of SDEAs
  • Negotiating safety aspects to be included in the SDEAs with business partners


Provision and Support with EU-QPPV & DQPPV


  • 24/7/365 Support with EU QPPV & DQPPV Good PV Practice Modules (GVP) - New EU PV Regulations
  • Oversight of the PV System in terms of structure & performance to ensure appropriate collation of ADRs, preparation and sign off of regulatory documents (PSURs etc) and Post-Authorisation Safety Studies (PASS Studies)
  • Ensuring all requests from Regulatory Authorities are answered completely and promptly

Quality Assurrance (QA) Services: Audits; Inspections GVP and GCP


  • Review & manage Compliance metrics for ADR reporting to regulatory authorities
  • Undertake Mock PV Audits for QPPV Office & Global PV depts.
  • Undertake GCP Audits
  • Develop & Implement Quality Management System (QMS)
  • Support & Prepare for Inspection readiness & business partner and external audits
  • Gap Analysis of systems & processes
  • Identify and Prioritize improvements & CAPA support for closure of inspection findings


Signal Detection- Benefit Risk Evaluation


  • Support with Identification and Prioritization of Signals from company databases
  • Complete work up of signals including, signal evaluation, epidemiological input and closing of signals
  • Authoring of Signal Evaluation Reports (SERs) or Issue Work Ups of signal for regulatory submission
  • Communication of Signals to Regulatory Authorities and Prescribers
  • Authoring of Dear Doctor & HCP Letters


Risk Management Plans/ REMS


  • Authoring and preparation of EU RMPs and REMS
  • Help & Support with preparation of Medication Guides, Educational Materials and other Risk Minimisation Plans
  • Help & Support with Survey and testing as a measure of effectiveness of RMP/REMS with patients and prescribers


Labelling: IB; SmPC, PIL, CCDS & USPI


  • Preparation and authoring of labelling documents and Reference Safety Information for products (CCDS, SmPCs, IBs, PILs)


Education & Training in Pharmacovigilance


  • Pharmacovigilance specific trainings for PV/Safety departments
  • Comprehensive Interactive e-Learning Certificate Course in Pharmacovigilance & Pharmacoepidemiology


Pharmacoepidemiology Services


  • Epidemiological Literature Searches & Reviews
  • Support with Study Design & protocols for studies
  • Support with PASS Studies
  • Authoring of Pharmacoepidemiological Study Reports
  • Post– Approval Safety Studies (PASS)


Medical Writing Services


  • ICSR Narratives—Company Assessment & Comments
  • Causality Assessments
  • Risk Benefit Assessments
  • Analysis of Similar Events
  • Integrated Safety Summary (ISS)
  • NDA Clinical Report Safety Sections
  • Patient Profiles in Clinical Trials Study Reports
  • Preparation of Clinical Overview & Clinical Summary
  • Safety Signal Evaluation Reports
  • Preparation of PBRERs, PADER, DSUR, SBR
  • Preparation , authoring & maintenance of PSMF
  • Risk Management Plans (EU RMPs, REMS, PIPs)
  • Phamacovigilance Plans
  • Reference Safety Information (CCDS; SmPc, PI, IBs)
  • Dear Doctor & HCP Letters


Clinical Data Management Services


  • MedDRA Coding and Data Analysis
  • Reconciliation of Clinical & Safety Databases
  • Migration of Data and Legacy data from various databases
  • Generation of CIOMS Line Listings
  • Aggregate Reports: PBRERs, PADERs, DSURst
  • Analysis of data for signal detection
  • Data Mining from various databases


Clinical Drug Development Services


  • Clinical Trial Safety Support - Phase I, IIa, IIb & III
  • Preparation of Medical Management Plan
  • Preparation of Safety Management Plan
  • Preparation of Safety sections of eCTD for NDA, IND & BLA sub- missions
  • NDA, IND and BLA Safety Review
  • Authoring of ISS and Clinical Study Reports (CSRs)
  • Compassionate Use Programs Support & Monitoring


Regulatory Strategy Help & Support


  • xEVMPD Support for maintaining products on EV Database
  • Preparation /Review/Compilation of IMPD, BLAs
  • Preparation of CTD Modules 1.8.1 (PSMF) & 1.8.2 (RMP)
  • Regulatory Strategy Support in Early Development, Ph. IIb—III, Post-Marketing & Lifecycle Regulatory Support
  • Preparation of eCTD regulatory dossiers


Regulatory


  • Book in, Triaging & 24/7/365 Case Management Support
  • Data entry into validated electronic PV database
  • 100% Quality control of all ICSR including medical QC
  • Medical review and assessment, narrative writing, MedDRA coding
  • Product Quality Complaints Management
  • Reporting & Submissions: Electronic (E2B), Hard copy (CIOMS, MedWatch 3500A drug, etc.) to worldwide regulatory authorities

Research & Innovation




Analysis and deployment of adverse events report systems


Graphic analysis & data mining in pharmacovigilance


Computer architecture for PV based systems


Data mining for signal detection applications

What They Say

"Excellent knowledge in pharmacovigilance especially in Signal Detection and Risk Management. Approachable and executes work meticulously, accurately and on time”
Senior Safety Science Leader, Roche Pharma
"Deep understanding of safety risk management; is a real asset to companies needing pharmacovigilance support."
President & CMO, Glenmark Pharmaceuticals
"Professionals with an abundance of pharmacovigilance experience used to produce quality work in a timely fashion. Symogen values success of the team and is genereous in sharing their experience, knowledge and time."
Director, International PV, Eisai
"Expert knowledge of PV, enthusiasm, leadership & excellent skills."
Senior Pharmacovigilance Manager, Astellas Pharma

Current Vacancies

Working for Symogen offers you a unique opportunity to gain experience and develop skills in the Pharmacovigilance sector.
With a scope for versatility, initiative and creativity in a stimulating and supportive environment.

DRUG SAFETY ASSOCIATE


  • Adverse event case entry and case processing, coding and narrative writing of serious and non-serious cases.
  • Processing of adverse event reports from clinical studies, post-marketing studies, spontaneous, regulatory authority and literature report sources.
  • Writing patient narratives.
  • Coding of cases and identifying missing information.

DRUG SAFETY PHYSICIAN


  • Provide medical review of individual case safety reports (clinical and spontaneous, serious and non serious), including coding, seriousness, expectedness and causality assessment for client products.
  • Ensures that appropriate medical interpretation and consistency are applied to adverse event case assessment.
  • Be the pharmacovigilance expert for assigned drugs or biologics, maintain current knowledge of full product portfolio and safety profiles for products.

AGGREGATE REPORT WRITING SPECIALIST


  • Assist and support the medical and scientific functions within safety evaluations for assigned products including preparation and coordination of reviews of individual case safety reports as well as aggregate safety data including authoring and preparation of PSURs and PADERs.
  • Support Risk Management Plans by serving as a coordinator for the acquisition and preparation of data for review from multiple sources.
  • Collect, and/or organize the data collected as part of Pharmacovigilance plan, RMP, product recalls and surveillance activities and support physician in authoring of reports.

SAFETY MEDICAL DEVICE SPECIALIST


  • Process, assess and investigate adverse incident reports from medical device products ensuring timely submission of cases.
  • Proficiency in MedDRA or other adverse event coding dictionaries.
  • Assist and participate in review meetings.
  • Prepare Medical Device Reports and other safety documents (MED DEV FORMS) and Decision Trees.

Our Offices

Symogen UK - HQ




8 Boston Drive, Bourne End Buckinghamshire, SL8 5YS +44 (0) 1628 566511 / +44 (0) 1628 525602 info@symogenlimited.com

Symogen UK - Office





Unit J, Bourne Park, Cores End Road, Bourne End, SL8 5AS +44 (0) 1628 878322 info@symogenlimited.com

Symogen Inc. (Subsidiary) - US Office




33 Wood Avenue South, Suite # 412, NJ 08830 +1 732 947 4877 / +1 732 603 5258 info@symogenlimited.com

Symogenesis (Subsidiary) - India Office





16, Ground Floor, DFL Tower B, Jasola , New Delhi +44 (0) 1628 566511 / +44 (0) 1628 525602 info@symogenlimited.com

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8 Boston Drive, Bourne End, Buckinghamshire, SL8 5YS +44 (0) 1628 566511 / +44 (0) 1628 525602 info@symogenlimited.com symogenlimited.com