Pharmacovigilance SOPs

Pharmacovigilance Standard Operating Procedures (SOPs) are documented procedures designed to provide a systematic and standardized approach to collecting, recording, monitoring, and reporting adverse drug reactions (ADRs) or adverse events (AEs) associated with the use of pharmaceutical products.

Purchase Options

  1. Single SOP Purchase

    • Select your desired SOP and click the “Buy” button to purchase it individually.

  2. Complete SOP Bundle (Best Value!)

    • Get all SOPs at a 30% discount from the total price $ 2681 by clicking the “Bundle Offer” button.

  3. Custom Multi-SOP Order

    • Need multiple SOPs? Fill out the order form below, and we’ll send you an invoice. Your order will be processed upon payment confirmation.

Payment Methods

  • Pay via wire transfer or via PayPal or a credit card (linked to PayPal or as specified in the order form).

Pricing & Discounts

  • Each SOP is priced as listed.

  • Order 4+ SOPs and receive a 5% discount on the total.

  • Bundle Deal: Purchase the full set of SOPs for a 30% discount.

Delivery & Support

    • Your SOPs will be delivered as a soft copy (PDF/Word) via email within 7 working days.

    • The price includes one free assistance session for local customization to fit your company’s needs.

SOPs List Available

Collection, Assessment, Processing of Adverse Events and SAEs

Scope of SOP

Post-marketing adverse events processing from any source
Buy $ 99

Aggregate Reporting - PSUR

Scope of SOP

Management & preparation of periodic reports, PSURs.
Buy $ 99

Literature Screening

Scope of SOP

Detection of adverse event case reports through routine surveillance of scientific and medical literature
Buy $ 99

Implementation of safety variations to SmPC and patient information leaflets

Scope of SOP

Describe Procedure of Implementation of safety variations to SmPC and patient information leaflets
Buy $ 199

PV Training

Scope of SOP

The establishment of training requirements to ensure that the staff engaged in activities related to AE processing is trained
Buy $ 99

Signal Detection and Risk Management

Scope of SOP

The assessment of and update to the risk-benefit profile for company products
Buy $ 199

QPPV Role and Responsibilities

Scope of SOP

Describes the role and responsibilities of the QPPV and Deputy for marketed products.
Buy $ 99

PSMF Development

Scope of SOP

Describes activities & responsibilities Required for preparation, review, approval & maintenance of PSMF
Buy $ 199

Safety Data Exchange Agreements

Scope of SOP

Preparation & revision of Safety Data Exchange Agreements with business partners of the company
Buy $ 199

Product Quality Complain Issues, Recall or Withdrawal

Scope of SOP

Define the procedure and timeline regarding products quality compalin issues, and recalls or withdrawals
Buy $ 199

Communication of Safety Concerns to Consumers

Scope of SOP

The process of communication of safety concerns to consumers, healthcare professionals & national medicines authorities
Buy $ 99

Deviation Documentation

Scope of SOP

The management, processing, review, approval, and closeout of SOP deviations, planned or otherwise
Buy $ 199

SOP Creation, Format, Content, and Maintenance

Scope of SOP

The format, responsibilities, approval, periodic review, maintenance, & usage of controlled documents
Buy $ 99

CAPA Processes for PV

Scope of SOP

The CAPA System which apply to Dept.audit that involve deviations regarding regulations of established procedures
Buy $ 199

Good Documentation Practices

Scope of SOP

The minimum standards for GDoP and ensures that errors are properly corrected and noted as to their nature.
Buy $ 199

Management of Inspections

Scope of SOP

The responsibilities, conduct,& activities during the local regulatory inspections & post-inspection responses to findings and observations.
Buy $ 99

Document Retention

Scope of SOP

The retention of Product Safety Records.
Buy $ 99

Risk Management System(s) and Monitoring of the outcome of Risk Minimisation Measures.

Scope of SOP

Describe the procedure of Risk Management System(s) and monitoring of the outcome of risk minimisation measures
Buy $ 199
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3- Buy More than One SOP of Your Selection

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After Submitting the order , you will recive an email of confirmation , then will send you the invoice for payment

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