Job Description

Join to apply for the Drug Safety Specialist role at Planet Pharma Join to apply for the Drug Safety Specialist role at Planet Pharma Position Summary The Drug Safety Specialist is primarily responsible for case processing of serious adverse events, serious and non-serious adverse drug reactions and other medically related project information such as adverse events of special interest and product complaints. Job Description Pay range: 61-64/hr depending on experience

DRUG SAFETY SPECIALIST

Position Summary The Drug Safety Specialist is primarily responsible for case processing of serious adverse events, serious and non-serious adverse drug reactions and other medically related project information such as adverse events of special interest and product complaints. This position is fully remote. Essential Duties And Responsibilities Reviews, processes, and assesses adverse event reports (AERs) from clinical trials and post-marketing sources Enters and maintains safety data in the global safety database Prepares and submits safety reports to regulatory authorities in accordance with global safety reporting requirements Performs QC of cases to ensure quality levels are maintained per DOB’s expectations Manages the safety intake mailbox including the triage of incoming reports for completeness, legibility, and validity Query management Maintains electronic documentation for case files within the safety database Assists with reconciliation of the safety and clinical trial databases Collaborates with cross-functional teams to ensure timely and accurate reporting of adverse events to regulatory agencies Adheres to all relevant pharmacovigilance regulations and company policies Assists in development of project-specific safety procedures, workflows, and templates. Assists in project-specific safety database setup, management of data entry guidelines, and user acceptance testing. MedDRA and WHODrug coding in the safety database Preparation for, participation in, and follow-up on audits and inspections Provides training and guidance to colleagues on drug safety processes and procedures. Stays updated on industry developments and changes in drug safety regulations. Maintains confidentiality and adheres to ethical standards in handling sensitive and confidential information. Performs other duties and responsibilities as assigned by management. Qualifications Degree in Pharmacy, Nursing, Life Science, or other fields, or equivalent qualification/work experience The ideal candidate will have 2+ years of recent case processing experience and must include experience processing post-marketing cases MedDRA and WHODrug coding experience Must be fluent in English with excellent written and verbal communication skills Detail orientated and capable of working effectively within a team environment. Excellent organizational and prioritization skills Analytical and problem-solving skills Able to perform database/literature searches Experience working in RxLogix’s Pharmacovigilance Case Management system a plus The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Seniority level Seniority level Not Applicable Employment type Employment type Full-time Job function Job function Management and Manufacturing Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Get notified about new Drug Safety Specialist jobs in South San Francisco, CA . Alameda, CA $351,500.00-$408,000.00 5 days ago Associate, Global Patient Safety Operations (TMF) South San Francisco, CA $115,500.00-$140,000.00 5 days ago Senior Director, Good Clinical Practice and Good Pharmacovigilance Practice Quality Assurance South San Francisco, CA $228,098.00-$281,768.00 1 month ago Alameda, CA $72,100.00-$114,700.00 1 week ago Hayward, CA $80,000.00-$95,000.00 2 weeks ago Alameda, CA $72,100.00-$114,700.00 1 week ago Alameda, CA $149,500.00-$213,000.00 3 days ago Foster City, CA $106,000.00-$123,000.00 3 days ago Director, Pharmacovigilance Quality Assurance Redwood City, CA $218,400.00-$256,900.00 1 week ago Alameda, CA $79,500.00-$138,700.00 2 weeks ago Alameda, CA $72,100.00-$114,700.00 5 days ago Clinical Research Associate (6-Month Contract) Preclinical Discovery Research Associate Senior Medical Director, Patient Safety & Pharmacovigilance South San Francisco, CA $287,292.00-$354,891.00 1 month ago South San Francisco, CA $34.00-$56.00 6 days ago San Francisco, CA $70,000.00-$110,000.00 6 days ago Sr. Pharmacovigilance Risk Management Medical Director Alameda, CA $270,500.00-$384,000.00 1 week ago San Francisco County, CA $90,000.00-$130,000.00 2 weeks ago Senior Clinical Trial Management Associate Fremont, CA $89,000.00-$148,000.00 6 months ago Sr. Study Specialist, Global Study Operations We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Planet Pharma

Job Tags

Full time, Contract work, Work experience placement,

Similar Jobs