Drug Safety Specialist

  • Budget 0.00$
  • Location USA

Posted on April 15, 2020

In progress

Project Desciption

Looking for an active member of the team to conduct the following tasks.  Role is expected to be part time- 10 to 15 hours per week, can be remote.

PV vendor oversight

·        Establish relationship with Syneos and provide ongoing oversight via regularly scheduled meeting

·        Review of project specific documents

·        Ensure Syneos is delivering on tasks as defined in the SOW

·        Miscellaneous safety operations related tasks as assigned

Manage Signal Detection/Safety Assessment Program

·        Review current safety plan

·        Contribute to the IDMC (Independent Data Monitoring Committee) charter and TLFs

·        Develop core safety information in concert with Clinical Development

·        Lead Safety Management Activities for Internal Team in concert with Syneos

PV Strategy

·        Participate in study execution team (SET) meetings

·        Participate in other study related meetings as needed

·        1:1 meeting with Alladapt personnel

·        Provide PV strategic advice to Alladapt

Inspection readiness

·        Review Syneos SOPs as needed and supplement SOPs requisite to support the PV system

·        Ensure oversight of Syneos is documented

·        Contribute to Syneos expedited reporting plan for IND and investigator submissions

·        Ensure internal safety reviews and any actions taken are documented

not in scope:

FDA Submission

·        Assess if REMS will be needed to support submission and if so, develop strategy

·        Contribute to writing and/or reviewing Module 2 documents and the safety sections of the USPI

Launch readiness

·        Ensuring that the PV system is ready for post-marketing (PM) cases

o   Write/update SOPs to include PM sources of AEs and processes specific to PM cases

o   Work with QA to qualify vendors who have the potential to learn of AEs (patient advocacy vendors, patient support programs, specialty pharmacies, market research)

o   Write pharmacovigilance agreements (PVAs) and train these vendors

o   Develop a plan to write the Periodic Adverse Experience Report (PADER) which is due to FDA every 3 months after approval

Hiring Entity Information

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Member since: April 11, 2020