Safety Surveillance Scientist

A dedicated professional with 16 years of pharmacovigilance expertise, combining a strong nursing background with disease management skills to provide comprehensive safety surveillance and regulatory intelligence.

Experienced in leading project management roles for safety surveillance, including DSUR/PSUR preparation, signal management, and process improvements for pre and post-marketed products.

Proficient in pharmacovigilance systems, with a focus on maintaining compliance, conducting risk management planning, and providing strategic input for complex regulatory documents.

Skilled in training and process improvement, contributing to the development and implementation of procedural documents, and ensuring adherence to pharmacovigilance requirements across multiple functions.

Aggregate reports: Lead project management role of DSUR/PSUR preparation for several marketed products in Europe overseeing a vendor

Signal identification, evaluation and mitigation

Utilizing an online platform, Rx logic to track all signals

Maintaining safety signals within the system

Compiling signal management plans for associated products

Project management: Serves as a project manager for safety topics related to signal management and aggregate report and ensures adherence to project timeline

Review and assess all respective literature per assigned products in accordance with associated SOP and WIs

Comparison and gap analysis of respective product CCDS and SmPC’s

Support and action all Safety Surveillance activities for pre and post-marketed products

Lead process improvements for areas as assigned, including proposing and obtaining agreement on methods and implementing

Conduct proactive pharmacovigilance and risk management planning

Update procedural documents and arrange and provide training, as required

Provides strategic input and oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines

Support the QPPV Office team with actions required to fulfil the legal obligations to set up and maintain performance of the quality system and the pharmacovigilance activities of the marketing authorization holder [IR Art 10(2)]

Work with QPPV Office team to identify and implement process improvements to ensure a compliant pharmacovigilance system

Lead all aspects of the PSMF, including training across all functions

Contribute to continuous improvement of the pharmacovigilance system, including monitoring of key performance indicators

Lead respective oversight and updates for all SOPs and Guidance documents

Contribute to internal and external audits and inspections

Lead PV regulatory intelligence updates and oversight

Leads and/or conduct proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk

Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products

Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports

Leads the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products

Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines

Acting as PV consultant and contact on a client’s program that may encompass several projects

Providing scientific input and expertise for all related PV documentation

Provide expert support and guidance with associated case management activities (Argus)

Review and tracking of global and local literature

Compiling detailed assessments report associated with multiple and complex literature articles

Provide respective support compiling aggregate reports, including DSURs and PBRERs

Performing signal detection related activities, per client’s request

Maintenance of local PV processes and procedures

Training and tracking of all external providers on appropriate PV-related procedures

Ensuring awareness of any programs/contractual arrangements with external providers

Tracking safety reports from a variety of sources within specified timelines

Maintaining oversight of outsourced vendors with PV responsibilities

Assisting with regulatory requests or audits/inspections

Monthly reports on PV metrics

Oversee PV Operations Vendor’s compliance and follow-up activities

Responsible for PV oversight for Company’s patient support programs and homecare

Assisting with late case investigations, CAPAs and deviations

Together with the Head of PV establishing a fully operational and compliant PV system, supporting the Head of PV and Medical information in the transition of the PV activities from the PV service provider in-house

Change management and associated transition and migration plan activities

Due diligence activities and responsible for tendering for EU QPPV and external auditor services

Assistance with scientific literature review

Responsible for the set up and maintenance of the risk management system including preparation of the signal detection

Preparation and maintenance of Pharmacovigilance agreements

Prepare training materials and deliver Pharmacovigilance training for employees/partners/distributors

Preparation of global Pharmacovigilance related procedural documents including SOPs and work instructions

Support in relation to case management activities, data migration activities (Safety Easy database)

Establishment and Support of the Local Pharmacovigilance Responsible in the preparation of local PV procedures

CAPA and deviation management. Effectiveness checks and assessment

Preparation and maintenance of the Pharmacovigilance System Master File (PSMF)

PV compliance management- preparation of ICSR compliance and metrics

Maintain up-to-date processes for safety-related aspects of interventional clinical trials, to meet current and evolving PV legislation

Provide support and review of all clinical trial documentation which may include and are not limited to clinical trial protocol, safety management plans, CRO selection and training, and reconciliation plans

Ensure that processes are in place to enable full compliance with the PV requirements for non-interventional studies (NIS) and all related clinical trials

Assist with the update to the clinical trial application

Provide expertise and support in relation to the setting up of safety-related sections within the eTMF

Patient Data Collection Systems (PDCS) - Ensure that the process for PV requirements for PDCS and Digital Media is current with the legislation, is correctly described in the respective SOP, and is communicated within the company to enable full compliance