Associate Director, Drug Safety and Pharmacovigilance Scientist

Location
Redwood City, CA
Posted
Nov 24, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Associate Director, Drug Safety and Pharmacovigilance Scientist

The Position:

Bolt Biotherapeutics, a dynamic biotechnology company located in Redwood City, CA. is recruiting for an Associate Director, Drug Safety. The ideal candidate will work closely with the head of Clinical Operations and Clinical Development team to ensure appropriate and timely execution of pharmacovigilance activities in support of Bolt Biotherapeutics clinical development efforts. The successful candidate will be responsible to ensure the highest quality oversight and reporting of drug safety for Bolt clinical candidates.

The Role:

As a Global Drug Safety and Pharmacovigilance Scientist you will be responsible for drug related activities in close cooperation with the clinical operations and development group. The position reports to the Vice President, Clinical Development.

Key Responsibilities Include:

  • Perform safety review of Adverse Event reports
  • Perform ongoing surveillance (including signal detection/evaluation) of safety data from clinical trials
  • Be the primary safety contact for other departments and ensure appropriate and timely handling of safety issues
  • Review MedDRA and WHO Drug coding as needed
  • Review case narratives as needed
  • Oversee case triage
  • Provide safety review and input to various documents including but not limited to: Trial Protocols, eCRFs/CRFs, and TMFs
  • You will also be contributing to the development of other documentation such as: Investigator’s Brochures, Subject Informed Consent, and Development Safety Update Reports
  • Contribute to the planning and conduct of Safety Committee activities
  • Conduct safety training of Bolt employees, CROs, Investigators and other relevant site personnel as necessary
  • Contribute to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products
  • Contribute to the development and optimization of new tools and process
  • Interact with safety and clinical CROs, perform sponsor oversight activities for safety related tasks, process invoices, and ensure regulatory compliance (including regulatory reporting requirements) for assigned products.
  • Provide vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics.
  • Oversee Safety Data Exchange Agreements with partners as required
  • Collaborate with external experts and partners
  • Perform ongoing surveillance of new and updated regulations/guidelines and assess the impact on drug safety processes at Bolt
  • Ensure compliance with regulatory guidelines and internal processes and procedures in order to be prepared for audits and inspections
  • Participate in audit and inspection activities as required

Preferred Skill Sets:

  • Bachelor's degree in nursing, pharmacy, or other health care related profession or life sciences preferred.
  • Master's or Doctorate level degree in health care related profession preferred, but not essential
  • Minimum of 8 years of experience in drug safety/Pharmacovigilance in a pharmaceutical industry setting or the equivalent.
  • Experience working with CROs, vendors, and relationship management.
  • Global pharmacovigilance operations experience with products in development.
  • Safety database, MedDRA coding and data entry experience.
  • Excellent knowledge of FDA and EU legislation and ICH Efficacy guidelines.
  • Strong analytical and problem-solving skills with superb attention to detail.
  • Strong verbal, written technical communication and presentation skills.
  • Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
  • Proven ability to work within a cross-functional, matrixed team.

Moreover, you meet the following personal requirements:

  • Strong communicator and good at building professional relations to collaborators and business partners.
  • You are proactive and able to prioritize work in a fast paced and changing environment
  • You are result-and goal-oriented and committed to contributing to the overall success of Bolt.

Who We Are:

Bolt Biotherapeutics, based in the San Francisco Bay Area, is a clinical-stage biotechnology company developing Boltbodyâ„¢ Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics that have eliminated tumors following systemic administration in preclinical studies while also developing immunological memory, which may lead to more durable clinical responses for patients. This is a unique opportunity to join and build, with likeminded colleagues, a company that will transform the lives of individuals with cancers.

We are an Equal Opportunity Employer offering a competitive salary and benefits package.