Job Description

In collaboration with IDSCU, to supervise and maintain an efficient pharmacy vigilance system in compliance with the national regulation for drugs and with Maharini PhV procedures, ensure full suite of PhV SOPs are in place and function as Local Safety Officer including training and medical assessment.

A bridge between clinical research and the marketing and sales department as well as the remaining departments within the organization. He/she specifically provides an authoritative opinion and answers medically based questions concerning medical, legal and regulatory matters enabling colleagues to comply with the relevant statutory requirements.

In charge of the defined therapeutic area and is taking the overall responsibility to medical input support the business teams.

Responsible for pro-actively involving in all aspects of a product's life cycle, from pre-launch to subsequent promotion, through marketing and sales, by providing medical input to enhance the product's value in all areas of business

Responsibilities

AE Processing：To collect, process and follow up all local adverse events (AEs) from different sources

To report the AEs to the HA according to the Chinese regulation within the required timeframe and answer any subsequent questions in collaboration with Regional Director –Pharmacovigilance in liaison with the GPV (Global Pharmacovigilance)

To log in cases into the local tracking system and transmit all reports to the IDSCU within the required timeframe; answer the queries of the IDSCU in a timely manner

To answer the safety questions from the Health Care Professionals with the support of Regional Director – Pharmacovigilance

To archive all source documentation in accordance with standard operating procedures

To maintain a record of PhV source documents and keep them available on request by the HA

Studies Activities