Novotech, a leading Asia-Pacific biotech specialist CRO, provides comprehensive clinical development services across various therapeutic areas. With over 3,700 clinical projects completed, including Phase I-IV trials and bioequivalence studies, Novotech is dedicated to delivering high-quality results for biopharmaceutical clients globally. Headquartered in the Asia-Pacific region, Novotech has offices in 11 geographies, including the U.S. and U.K., and employs over 2,750 full-time experts. The company’s commitment to quality and security is demonstrated by its ISO 27001 and ISO 9001 certifications, ensuring stringent information security and quality management standards.
Responsibilities in the Role of Drug Safety Associate
As a Drug Safety Associate, you will manage adverse event reporting processes to ensure compliance with global safety regulations. Responsibilities include:
- Overseeing drug safety reporting, ensuring accurate database configuration and review.
- Case processing: triaging, reviewing, and completing adverse event reports while ensuring quality and compliance.
- Communicating with clients, medical monitors, and safety physicians to clarify information.
- Ensuring timely submission of reports to regulatory agencies and responding to inquiries.
- Participating in audits, inspections, and pharmacovigilance project teams.
- Mentoring junior staff and staying updated on regulatory requirements for ICSR, DSUR, PSUR, and PBRER.
Qualifications and Experience Required
The ideal candidate should have:
- A registered nurse, pharmacist, or health/biomedical degree.
- A minimum of 2 years of drug safety experience in a pharmaceutical company or CRO.
- Proficiency in international drug safety regulatory reporting, case processing, and client communication.
- Strong medical terminology knowledge and an ability to write clear medical texts.
- Experience with standard operating procedures (SOPs) and a proactive approach to learning new therapeutic areas.
Skills You Should Have
- Excellent communication and interpersonal skills.
- Strong attention to detail with the ability to manage multiple tasks simultaneously.
- Good knowledge of medical terminology and drug safety regulations.
- Ability to work both independently and as part of a team.
- Proficiency in safety databases and reporting systems.
