Pharmacovigilance Associate Analytics & Reporting

The Pharmacovigilance Associate Analytics & Reporting will:

* Ensure that regular signal detection is performed;
* Coordinate and/or prepare Aggregate Reports and Risk Management documents;
* Contribute to oversight and training of external service providers for PV Analytics and Reporting activities.

Responsibilities:

* For assigned Galderma products (drugs, device, cosmetics), compile or contribute to maintenance of Post market surveillance plans, Periodic Safety Update Reports (PSUR, PBRER, ASR, CoSR, etc.), Safety Summaries and Clinical Overviews, Risk Management documentation, and other routine and non-routine safety and benefit/risk evaluations for internal or regulatory purposes
* Support Operations projects and Development projects, including study design discussions, and compilation of documentation for study submissions, safety sections of protocols, Investigator Brochures, and Clinical Study reports for assigned studies, etc.
* Support as applicable with Safety management plan (SMP) review and SAE/SUSAR/AESI review and submissions
* Coordinate and contribute to the preparation of Development Safety Update Reports (DSURs)
* Ensure regular and ad hoc safety data trending and signal detection and evaluation, including regular ICSR data review
* Contribute to the regular post-market surveillance review meetings and to safety sections in the product Clinical Evaluation reports and Post-Market Clinical Follow-up reports for assigned device products
* Provide guidance to external PV vendors
* Prepare responses to Regulatory Authorities or other internal or external stakeholders for questions related to the safety of assigned products
* Participate in creation, maintenance and review of quality documents, preparation of internal and external audits/inspections, and implementation of any CAPAs related to department activities
* Maintain and optimize harmonized methods, workflows and processes within department areas of responsibility
* Contribute to the training of internal and external functions

Requirements:

* Pharmacist / Life sciences degree
* At least 2 years in pharmacovigilance in the pharmaceutical/medical device industry with good knowledge of PV ICSR management and knowledge of aggregate reporting, risk management and signal detection
* Solid comprehension of international PV standards(ICH, ISO, etc.) for drugs, cosmetics and medical devices (as applicable) along with good understanding of local and global regulatory roles and regulations
* Knowledge of MedDRA coding conventions and SMQs
* Relevant medical writing background, eg. aggregate reports, with the capacity to interpret and compile large amounts of data from multiple sources
* Experience with the following IT tools: Microsoft Office (Word, Excel, Power Point), eDocument Management, CAPA's and Change Control management, PV computerized systems, Signal detection tool
* Ability to operate in a global multifunctional team and take accountability to ensure deliverables within agreed timelines
* Interpersonal skills
* Fluency in English