Director, Pharmacovigilance (PV)

Job Title: Director, Pharmacovigilance (PV)

Reports To: Chief Medical Officer

FLSA Status: Exempt

Department: Safety

LOCAL CANDIDATE PREFERRED

PRIMARY RESPONSIBILITY

Candidates for Director, Pharmacovigilance, independently or in consultation with the Medical Monitor, will be responsible to serve as the Head of Pharmacovigilance and provide Pharmacovigilance leadership for all investigational and commercial products. This includes assuring the timely and accurate collection, review, and analysis of all safety events (i.e., AEs, SAEs), including safety reporting and compliance. The PV Director will oversee implementation and maintenance of the safety database as well as develop and implement coding standards for adverse events and concomitant medications. This position is also responsible for oversight and management of global PV vendor(s).

The Director, Pharmacovigilance should be able to perform the following tasks:

  • Optimize and oversee processes for management of adverse events, including serious adverse event (SAE) information from clinical studies and ensure compliance with safety reporting timelines
  • Oversee implementation and maintenance of the Safety Database maintained by PV vendor and/or CRO 
  • Oversight and Management of PV vendor and/or CRO safety to develop and maintain the Pharmacovigilance Trial Master File and work with the EU Qualified Person for Pharmacovigilance (QPP)
  • Establish clinical and safety database AE/SAE reconciliation and AE/concomitant medication coding conventions and systems to ensure consistency across all studies
  • Contribute to safety sections and review clinical study or regulatory documents such as study concept documents, protocols, case report forms (CRFs), statistical analysis plans (SAPs), investigator brochures (IBs), informed consent form (ICF) templates, clinical study reports (CSRs), safety monitoring plans (SMPs), study manuals, regulatory submissions
  • Review aggregate safety events and perform trend analysis for signal detection
  • Responsible for drafting and development of DSUR and coordinate the review
  • Responsible for drafting narratives and final review/oversight 
  • Attend study team or other intradepartmental meetings to represent Pharmacovigilance
  • Plan Pharmacovigilance resources to support all clinical studies and programs
  • Chair the Pharmacovigilance Committee and lead safety related discussions and meetings
  • Support the preparation and review of DSMB materials
  • Provide training on safety processing and issues for clinical study team, Investigators, study coordinators, and regional site monitors, etc. as needed
  • Responsible to ensure departmental and company Standard Operating Procedures (SOPs) are adequate from a Pharmacovigilance perspective 
  • Create and manage departmental budget
  • Adhere to InCarda Therapeutics, Inc. Employee Handbook

Knowledge, Skill and Competency Requirements:

  • Experience providing Pharmacovigilance / Drug Safety support for clinical studies and commercial products; cardiovascular experience desired
  • Expert knowledge of domestic and international Drug Safety regulations/guidelines and Industry best practices or standards
  • Experience maintaining and validating Drug Safety databases; ARGUS experience preferred
  • Experience managing PV vendors/CROs who hold the Safety Database
  • Coding and reviewing experience with adverse event and medication coding dictionaries; MedDRA and WHO Drug experience required
  • Prior experience with Phase 3 clinical trial leading to marketing application with integrated safety dataset
  • Demonstrated ability to establish and meet priorities, deadlines, strategic department goals, and objectives
  • Experience in departmental budgeting, organizing, and planning
  • Excellent collaborative skills, ability to work in a start-up environment, and manage change complexity
  • Computer literacy including working knowledge of computer applications such as Word, Excel, and Outlook required
  • Ability to organize activities and multitask, be performance driven, and possess good decision- making skills
  • Strong verbal and written communication skills.

Education/Experience:

A Bachelor’s degree or higher in a scientific discipline with at least 7 years of Pharmacovigilance/Drug Safety experience; advanced or health-related degree a plus

Supervisory Responsibilities: 

This position has no current direct supervisory responsibilities within InCarda.  Candidate is responsible for management of vendors, CRO safety, and or safety advisors/consultants as applicable.