Drug Safety Specialist

Job description

  Job facts

In your role as Drug Safety Specialist, you will report to Drug Safety Manager. Your main responsibilities will be:

·  Safety oversight for all local related activities that trigger collection of safety information from spontaneous source, solicited sources
·  Management of case report: review safety information from all sources, triage, case processing, following up and submission
·  Management of Pharmacovigilance (PV) training for Affiliate personnel and ensure the PV training compliance rate aligned with global requirement
·  Information sharing with other departments, e.g., Drug Safety, Medical Information, Sales, Medical Affairs, Marketing
·  Management of Periodic Benefit and Risk Evaluation Report (PBRER) including tracking receipt, submission and record (as applicable)
·  Collaborating and supporting APAC Hub in the transition of applicable activities together with overseeing Hub performance in those transited

You have Pharmaceutical/Biology University Degree. Further experience, knowledge, skills and competencies are:

·  Minimum 01 year pharma industry experience, preferably PV experience
·  Understands, interprets medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology)
·  Familiarity with Pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulation, case processing and expedited reporting rules
·  Strong organizational and detail-oriented skills, including the ability to prioritize independently with minimal supervision
·  Fluent English (prioritized writing, reading)

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.