Pharmacovigilance Safety Surveillance Specialist

ProPharma Group; Makati; Presencial; PHP 500.000 - 800.000; Jornada completa

Descripción de la vacante

ProPharma Group is seeking a Pharmacovigilance Safety Surveillance Specialist in Makati City. The role focuses on daily adverse event case processing, MedDRA coding, and ensuring regulatory compliance for client projects.

You will perform literature searches, monitor health authority updates, and contribute to project documentation within a multidisciplinary team.

Formación

• Bachelor's degree in life sciences or equivalent.
• Advanced degree in health sciences preferred (RN/RPh/PharmD or similar).
• At least 2+ years of experience in pharmacovigilance.
• Knowledge of end-to-end PV case processing (clinical trial and post-market).
• Experience with literature screening is a plus.

Responsabilidades

• Oversee daily case processing of adverse events (clinical trial and post-market).
• Code using MedDRA and determine seriousness and expectedness.
• Conduct case follow-up and literature searches.
• Prepare client notifications and ensure regulatory compliance.
• Maintain project trackers and documentation; support Regulatory Intelligence.

Conocimientos

Pharmacovigilance

Attention to detail

Communication skills

Teamwork

Problem solving

Documentation

Educación

Bachelor's degree in life sciences

Advanced health degree (preferred)

Herramientas

Oracle Argus Safety

ARISg

Descripción del empleo

## Pharmacovigilance Safety Surveillance SpecialistApply: Makati City: Full time: Posted Today: JR 10569For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.**Job Summary:**The Pharmacovigilance (PV) Safety Surveillance Specialist performs case processing activities and supports the Benefit Risk group by ensuring day-to-day operational activities are completed.The PV Safety Surveillance Specialist maintains distinctive quality and commitment as the operating philosophy in carrying out all processes and continually seeks out ways to enhance customer service experience both internally and externally.**Essential Functions:*** Responsible for overseeing and performing daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level.* Perform case follow up activities such as identification of information to be collected during follow-up.* Creating and reviewing case narratives.* Providing client notifications as required for case management.* Independently completing tasks such as execution of literature searches and Health Authority website monitoring.* Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines.* Reconciliation of relevant process trackers.* Supporting the update and maintenance of project-related documents.* Supporting Regulatory Intelligence activities.* Acquire and maintain an up-to-date knowledge of global safety regulations for medicines.* Other duties as assigned.**Necessary Skills and Abilities:*** Strong verbal, written and interpersonal communication skills.* High level of accuracy and attention to detail.* Ability to identify and resolve problems in a timely manner.* Able to work within a multi-disciplinary team openly and professionally.* Sound organizational skills.* Intermediate knowledge of Pharmacovigilance.* Working knowledge of PV Systems, such as Oracle Argus Safety, ARISg, or other safety databases.**Educational Requirements:*** Required: a Bachelor's degree in life sciences, or other health-related field, or equivalent qualification/work experience.* Preferred: an advanced degree, RN, RPh, PharmD or equivalent.**Experience Requirements:*** 2+ years of experience within pharmacovigilance* Knowledge of both clinical and post market PV end to end case processing* Experiences in literature screening activities