Remote Safety Scientist, Global Patient Safety IV Job at Planet Group, Remote

cW9IYlpsRC9tN1gwZzVXTzRpQzRWNVdERHc9PQ==
  • Planet Group
  • Remote

Job Description


Pay 80-100/h depending on experience

Signal and Safety Data Evaluation
  • Lead the identification, analysis, and evaluation of safety signals
  • Define data acquisition strategy, methodology, and approach for safety evaluations
  • Perform analysis of safety data and lead authoring of safety assessment
  • Lead execution of signal assessment strategy and assess potential impact on the product safety profile with recommendation for action and initiate proposal for Safety Management Team
  • Lead the preparation and presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB)   
  • Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner.
  • Lead the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigator’s Brochure, Healthcare Professional communications [DHCP letter or DHPC], Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science team members and relevant cross-functional team members
  • Lead signal assessment documentation following company signal management and safety governance framework
Clinical Trial Support
  • Lead the review of safety data and monitor the safety of patients on allocated clinical trials
  • Lead the writing and review safety sections and provide safety expertise for development of Protocols, IBs, ICFs, Safety Analysis Plans (SAPs), Tables Figures and Listings (TFLs), Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project/study documents and answer ad-hoc safety queries from ethics committees
  • Support ad-hoc review of the Safety Management Plans
Risk Assessment, Regulatory Inquiries, and Periodic Reporting
  • Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report (PADER)/ Periodic Adverse Experience Report (PAER), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs)
  • Lead strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs
Requirements:
  • PharmD, NP, RN, or PhD in a medical field or biological science and 8+ years of experience as a Safety (Pharmacovigilance) Scientist.
  • Phase 1-3 clinical study experience
  • Protocol, IB, ICF development
  • SMC, DMC
  • SAE and aggregate data review and analysis
  • Signal detection and signal evaluation
  • DSUR authoring

Job Tags

Contract work,

Similar Jobs

ManpowerGroup

EXPERIENCED DELIVERY VAN DRIVER Job at ManpowerGroup

Our client, a leading dry cleaning and laundry service provider, is seeking an Experienced Delivery Van Driver to join their team. As a Delivery Driver, you will be part of the logistics department supporting customer satisfaction and timely service. The ideal candidate... 

T Bar M Camps

KITCHEN STAFF (PART-TIME) Job at T Bar M Camps

 ...Position Overview: This part-time position is in the Kitchen Department. Kitchen Staff, under...  ...as meat and vegetables Properly store food items at appropriate temperatures...  ...of calling to the ministry of T Bar M Whole-hearted support of T Bar Ms Vision, Core... 

CS Soft Solutions (India) Pvt Ltd

Senior Web Designer Job at CS Soft Solutions (India) Pvt Ltd

# Lead the design of websites and web applications from concept to final delivery. # Create wireframes, mockups, and prototypes using tools like Figma, Adobe XD, or Sketch. # Ensure responsive and mobile-first design principles are applied. # Collaborate with... 

Lakeview Lending LLC

Mortgage Loan Originator Assistant Job at Lakeview Lending LLC

We're searching for a detail-oriented mortgage loan officer assistant. This position will play a vital part in communicating with referral partners, current and past clients, real estate agents, lenders, and underwriters to nurture relationships and develop new business... 

Senior Helpers - Westford

Corporate Pilot with AgingCare Do Not Delete Job at Senior Helpers - Westford

Great people deserve a great place to work and Senior Helpers is hiring Caregivers in Westford, MA!Senior Helpers is proud to be the first and only national in-home care provider to receive certification as a Great Place to Work. Our caregivers and staff are treated ...