Pv Coordinator

**PURPOSE**

Coordinate and support the management of the pharmacovigilance process in the region including reviewing, triaging, assessing, and processing safety data received from various sources to ensure compliance with global/local procedures, regulations, guidelines, and Standard Operating Procedures (SPOs) for the investigational/marketed products.

**RESPONSIBILITIES**
- Performs, and manages the collection, documentation, triage, and processing of safety data in compliance with applicable regulations, guidelines, Standard Operating Procedures (SPOs) and project requirements.
- Assists the PHV specialist in the processing of safety events including serious adverse events and unexpected serious adverse reactions (SUSARs).
- Coordinates and contributes to the preparation of clinical safety documents for submission to the Health Authorities, Ethics Committees, Principal Investigators, and sponsors.
- Assists in timely submission of aggregate reports -PSUR/PBEBR, DSUR, Risk Management planning and reporting where applicable.
- Performs data entry, data management and reconciliation of safety data.
- Set up and maintains proper filing, storing, and archiving of safety-related and regulatory documents in accordance with the company policy and local requirements.
- Serves as a liaison with the external and internal stakeholders for the management of safety data and reports.
- Collaborates with the project team in preparation of meetings and preparing the necessary documents.
- Works in close collaboration with the project team and provides support on project-specific or safety-related issues if needed.
- Performs timely monitoring of PV regulations in the assigned country and inform the team if there is any regulatory update or changes which might impact the PV system
- Maintains a proper understanding of Standard Operating Procedures (SOPs), guidelines and regulations associated with safety management and reporting.
- Ensures compliance with high-quality standards and the deliverables are met according to the project requirements.
- Supports/develops training materials for PV training and maintains the training records.
- Ensures the required training is completed in a timely manner and documented and reconciled with the training certificate.
- Participates in internal and external training programs, and meetings to continually improve and build a knowledge base of product safety and risk management.
- Contributes and assists with audits and inspections and supports the implementation and development of CAPA if needed.
- Assists in the preparation, set-up and provide data to Safety Committees/DSMBs if needed.
- Performs other duties as assigned.

**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**
- Good knowledge and understanding of PV regulations, processes, and requirements in the APAC region.
- Experience working with the Argus safety database.
- Familiar with the preparation of safety reports for submission to the regulatory agencies.
- Able to work in an intense, fast-paced work environment.
- Strong interpersonal and intercultural skills.
- Effective time management skills.
- Good organizational skills, ability to prioritize work and adapt rapidly to changing priorities.
- Accountable for challenges and able to put in corrective and preventive actions with mínimal support or supervision.
- Excellent communication skills both verbal and written, fluency in the language of the host country is required.
- Take initiatives to ensure the project deliverables are met.
- Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
- Ability to work effectively on multiple projects simultaneously and able to organize own workload and effectively manage competing priorities.
- Proven ability to meet strict deadlines and able to provide high-quality safety data.
- Demonstrate a flexible and receptive approach to changing demands.
- Proven ability to work independently and autonomously.
- A good team player with the ability to function in a cross-functional environment.

**MINIMUM REQUIRED EDUCATION AND EXPERIENCE**
- Bachelor’s degree or equivalent qualification in health sciences, nursing, pharmacy, or biomedical sciences. Relevant experience in clinical research/pharmaceutical industry preferably in Pharmacovigilance/Drug Safety.
- Good knowledge of medical terminology.
- Expert knowledge of international regulatory safety reporting requirements, ICH guidance related to pharmacovigilance and GCP.
- Good understanding of drug development and life cycle management.