Understanding Pharmacovigilance Regulations in APAC Training Course

Drug Safety Manager at Pharma To Market

Mr. Param Dayal is a qualified Microbiologist with Master’s degree in Microbiology and a certified MedDRA coder. For the last 15 years, Param has worked on a variety of pharmacovigilance projects with special focus on ICSR processing (Unsolicited, solicited, Literature, legal and Clinical trials cases). In his previous roles he worked for organisations supporting pharma clients with PSP program management, PV audits, HA inspections, data migration, SOP Management, process refinement, providing PV training and mentoring to new staff. He also has experience working as a QPPV and Local Safety Officer for Australia and New Zealand. He is currently based in Melbourne working as Drug Safety Manager for Pharma To Market, managing PV activities for NZ clients.

Regulatory & Pharmacovigilance Assistant Manager

Ms. Siew Man Phang is a registered pharmacist in Malaysia, brings over 7 years of pharmacovigilance and regulatory expertise. She has served as QPPV for multinational pharmaceutical, generic, and distributor companies, gaining diverse experience across innovator drugs, generics, biologics, health supplements, traditional products, cosmetic and medical devices.

Additionally, she possesses extensive hands-on experience in pharmacovigilance, including adverse event monitoring & reporting, literature & regulatory Intelligence screening, risk management plan, SOP and PSMF writing. She is currently based in Malaysia, works as a Regulatory & Pharmacovigilance Assistant Manager in Pharma To Market handling various pharmaceutical clients, serving as QPPV and managing Pharmacovigilance activities in APAC regions.

Drug Safety Associate

Dr. Preeti Shergill holds a PhD in Biotechnology and brings over 8 years of experience in Pharmacovigilance, having worked extensively in India as a Safety Specialist and PV Manager.

Currently serving as a Drug Safety Associate at Pharma To Market, Dr. Shergill applies deep scientific knowledge and regulatory expertise to ensure the safe and effective use of pharmaceutical products.

With a strong foundation in biotechnology and a proven track record in drug safety, she is committed to advancing global health through vigilant monitoring and risk management.

Pharmacovigilance Specialist

Ms. Nurin Qistina Roslan is a master’s degree graduate in biomedical science with over 5 years of experience in Pharmacovigilance activities for multinational drug companies. She has hands-on experience in Pharmacovigilance for multinational pharmaceutical, generic, innovator, and biologic products at both local and global levels.

Furthermore, Ms. Roslan possesses extensive experience in adverse event monitoring and reporting, literature and regulatory intelligence screening, PSMF writing, and risk management planning. She is currently based in Malaysia and worked as a Pharmacovigilance Consultant at Pharma To Market, handling various pharmaceutical clients, serving as a QPPV, and managing Pharmacovigilance activities in the APAC region.

Regulatory Project Manager

Ms. Clarise Macalalad is a registered pharmacist in the Philippines with over 10 years of experience in Pharmacovigilance and Regulatory Affairs. She has served as a Qualified Person for Pharmacovigilance (QPPV) for pharmaceutical, generic, and distribution companies.

She brings extensive hands-on expertise in adverse event monitoring, regulatory intelligence, and risk management planning. Currently, she is based in the Philippines as a Regulatory Project Manager, handling a diverse portfolio of clients.

Ms. Sherley Wang
Pharmacovigilance (PV) Director

Ms. Sherley Wang brings over 16 years of experience in the pharmaceutical industry, including 11 years in pharmacovigilance and 5 years in clinical quality assurance. She has conducted more than 150 audits of hospital research centers and 100 audits of CROs and pharmaceutical companies, working with leading multinational organizations. Sherley serves as an authorised RPPV/QPPV for several domestic companies and plays a pivotal role in the development and oversight of compliant PV systems.

She authored the China Pharmacovigilance Industry Research Report 2024 and co-translated key pharmacovigilance texts in partnership with the CDE of the NMPA. A recognised industry expert, Sherley is a panelist for the China Food and Drug Industries Quality and Safety Promotion Association (FDSA) and teaches pharmacovigilance to graduate students at Tongji Medical College, Huazhong University of Science and Technology.

As a member of the China Institute of Internal Audit (CIIA), she is highly proficient in GCP, GVP, supplier audits, and regulatory inspections. Her expertise spans both domestic and international regulatory landscapes.

Ms. Marylene Zhan
Senior Pharmacovigilance (PV) Manager

Ms. Marylene Zhan holds a Master’s degree from Zhongnan University of Economics and Law and is a seasoned bilingual and bicultural consultant in the pharmaceutical industry. She brings extensive expertise in Chinese pharmaceutical regulations, with a specialisation in regulatory affairs (RA) and pharmacovigilance (PV) compliance.

With deep insight into China’s market access requirements and practical experience in navigating regulatory pathways, Marylene has successfully supported numerous international pharmaceutical companies in establishing and expanding their presence in the Chinese market. Her nuanced understanding of both local and global business environments makes her a valuable bridge between multinational firms and China’s regulatory landscape.