VP Drug Safety

Location
San Diego, California
Posted
Jun 16, 2022
Ref
oGM4jfwz
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Company Overview

 Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.

 

Job Summary

The Head of Drug Safety and Pharmacovigilance provides leadership, oversight and strategic vision for the Drug Safety Department. Major areas of responsibility include: ensure compliance with applicable Pharmacovigilance (PV) regulations and guidelines for the product portfolio at all stages of the product lifecycle; provide PV expertise and guidance to clinical development, the Safety Oversight Committee (SOC) and to Clinical Project Teams; evaluate emerging safety data and providing recommendations to the project teams and SOC; provide risk management guidance and deliverables; participate in benefit/risk assessments; oversee the safety contributions to Health Hazard Assessments; and serve as the Drug Safety/PV ambassador to business partners, investigators, regulatory agencies and the scientific community.

Essential Duties and Responsibilities

Responsibilities as Head of Drug Safety and Pharmacovigilance

  • In conjunction with the Chief Medical Officer and other functional/disease area heads of Clinical Development, sets the strategy for Drug Safety management of investigational and marketed products at Avidity, leveraging the outsourced model as appropriate
  • Oversees the activities of the Drug Safety group including SAE assessments (including AOSEs when applicable), safety notifications (e.g. DHCP letters), safety surveillance, coding, global safety database development, signal detection/evaluation and writing of regulatory safety documents (e.g. DSURs)
  • Ensures appropriate safety for all subjects treated in clinical trials sponsored by Avidity
  • Rapidly and effectively responds to any safety issues that affect any subject
  • Establishes and maintains Drug Safety policies and procedures in compliance with applicable regulations and guidelines
  • Ensures adequate and complete safety assessments in all the company’s clinical trials
  • Oversight of external vendors used to fulfil drug safety activities and ensure that they are performing at an appropriate level in line with contracted obligations
  • Provide guidance and oversee deliverables related to risk management (e.g. RMPs) and benefit/risk assessments
  • Liaison with regulatory agencies and business partners on drug safety matters
  • Oversee the safety contributions to Health Hazard Assessments
  • Ensures training in pharmacovigilance for all applicable Avidity employees in line with applicable regulations, guidance documents and best practices
  • Ensure consistency of safety assessments
  • Ensure that the assessments of all adverse events filings to Regulatory Authorities are consistent with company policies and the respective regulatory requirements
  • Responsible for ensuring inspection readiness for Regulatory Authority inspection activities related to Drug Safety/PV

General Responsibilities as Drug Safety Physician

  • Provide tactical support to the Safety Oversight Committee
  • Offer medical judgment on complex safety issues
  • Determine the most appropriate monitoring and stopping rules for clinical trial protocols in partnership with the project’s lead MD and/or medical monitor
  • Present safety data to DSMBs for assigned products
  • Liaison with partner company’s drug safety team and clinicians to ensure that safety data exchange agreements are in place and regular safety summaries are provided (bilaterally as appropriate)
  • Provide vendor oversight for assigned products
  • Participate in cross-functional project teams; this requires communication across all organizational levels and functions
  • Provide medical review of case narratives for medical content and accuracy
  • Participate in SOP updates, audits, data analysis and other ad hoc activities
  • Write/update core safety information and patient safety information for assigned projects
  • Write the safety sections of regulatory documents for assigned projects (i.e. protocols, IBs, IND submissions, annual reports etc.)
  • Prepare and/or review safety documents in response to regulatory inquiries
  • Remediate any PV deficiencies during regulatory or internal audits
  • Develop and operationalize a system for signal detection, signal evaluation and signal tracking/reporting
  • Support medical coding as required
  • Responsible for risk management (e.g. RMPs) and benefit/risk related deliverables for assigned products
  • Responsible for the safety contributions to Health Hazard Assessments for assigned products
  • Identify corrective actions and facilitate, support, and implement, as appropriate
  • Ensure appropriate clinical safety risk communication and escalation within the organization
  • Guide and/or train external personnel/parties involved in Avidity clinical studies
  • Provide clinical education support for internal company customers
  • Maintain clinical and technical expertise in the therapeutic areas and technologies in which Avidity is vested (i.e. through review of scientific journals, attend scientific and key technical meetings etc.)
  • Assist in accomplishing department and corporate objectives
  • May be required to act as medical monitor for some clinical trials
  • Other duties as assigned

Qualifications

To perform this role successfully, an incumbent must be able to perform each essential duty satisfactorily. The preferred requirements listed below are representative of the skills, knowledge, and/or abilities required.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Preferred Education and/or Experience

  • Medical degree (eg MD, MBBS)
  • At least 3 years of clinical experience post-registration
  • High level of medical competence, with an ability to balance this with industry standards to achieve business goals
  • At least 7 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery
  • A thorough knowledge of the pharmaceutical/ biopharmaceutical industry, especially clinical research and global regulatory requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities
  • Able to work across TAs and Functions
  • Works Collaboratively (establishes shared purpose across boundaries)
  • Develops People and Organization (invests in long-term development of others)