Sr Drug Safety Associate/Manager
Position Title: Sr Drug Safety Associate/Manager
PRIMARY PURPOSE OF POSITION: This position will be responsible for the collection, documentation and processing of serious adverse events from clinical trials in accordance with Federal Regulations and the company's Standard Operating Procedures. This position will also be responsible for managing the CRO drug safety functions. This position will be reporting to the Director of Clinical Research (MD).
MAJOR DUTIES OF POSITION:
· Follow case processing management of incoming SAEs from Phase I and II clinical studies through case approval and closure.
· Oversee CRO drug safety functions, CRO personnel, SAE reconciliation, SAE tracking of Phase III clinical trials
· Produce Clinical Safety Queries as needed for clarification of reports.Create and maintain workflow trackers, flow charts as needed
· Serve as a drug safety resource to other departments
· Work closely with medical monitors and interact on a regular basis with clinical operations and regulatory affairs to communicate project status updates.
· Identify process improvement strategies and develop/enhance internal drug safety processes and SOPs
· Draft SAE narratives for review by Medical Monitor KNOWLEDGE AND SKILL REQUIREMENTS:
· PharmD, RN, RPh, BS with at least six years of drug safety experience
· Working knowledge of ICH/GCP Guidelines, MedDRA and WHO_DRUG coding
· Familiarity with safety databases, data entry platforms, adverse event data collection process, 15-day safety alerts, submissions of safety updates to the FDA, BLA/NDA pre-approval process, FDA Industry Guidelines, ICH Guidelines, Regulatory Approval Process and Drug Development.
· Fluent in medical terminology
· BLA/NDA experience a plus
· Must have decision-making skills
· Positive attitude
· Able to manage own work flow independently
· Be a team player
mailto:raquel@biosearchbay.com
925-516-4323
PRIMARY PURPOSE OF POSITION: This position will be responsible for the collection, documentation and processing of serious adverse events from clinical trials in accordance with Federal Regulations and the company's Standard Operating Procedures. This position will also be responsible for managing the CRO drug safety functions. This position will be reporting to the Director of Clinical Research (MD).
MAJOR DUTIES OF POSITION:
· Follow case processing management of incoming SAEs from Phase I and II clinical studies through case approval and closure.
· Oversee CRO drug safety functions, CRO personnel, SAE reconciliation, SAE tracking of Phase III clinical trials
· Produce Clinical Safety Queries as needed for clarification of reports.Create and maintain workflow trackers, flow charts as needed
· Serve as a drug safety resource to other departments
· Work closely with medical monitors and interact on a regular basis with clinical operations and regulatory affairs to communicate project status updates.
· Identify process improvement strategies and develop/enhance internal drug safety processes and SOPs
· Draft SAE narratives for review by Medical Monitor KNOWLEDGE AND SKILL REQUIREMENTS:
· PharmD, RN, RPh, BS with at least six years of drug safety experience
· Working knowledge of ICH/GCP Guidelines, MedDRA and WHO_DRUG coding
· Familiarity with safety databases, data entry platforms, adverse event data collection process, 15-day safety alerts, submissions of safety updates to the FDA, BLA/NDA pre-approval process, FDA Industry Guidelines, ICH Guidelines, Regulatory Approval Process and Drug Development.
· Fluent in medical terminology
· BLA/NDA experience a plus
· Must have decision-making skills
· Positive attitude
· Able to manage own work flow independently
· Be a team player
mailto:raquel@biosearchbay.com
925-516-4323
posted by grace wang at
2:59 PM
