GENERAL SUMMARY:

Reporting to the Chief Medical Officer, the Contract (6-12 months) Sr. Manager of Safety/Pharmacovigilance Operations is responsible for providing oversight and day to day management of all activities pertaining to product safety and pharmacovigilance operations in clinical development, The Contract Sr. Manager of Safety/Pharmacovigilance Operations ensures that appropriate medical safety assessments and surveillance, compliant regulatory authority reporting, development and implementation of risk management strategies, and communication of safety information for 4DMT products.

RESPONSIBILITIES:

• In collaboration with the CMO, support the safety governance oversight for all company products.
• Collect, synthesize and deploy relevant drug safety information on all programs within 4DMT models.
• Organize and lead ongoing safety data review and signal detection, management of serious adverse event reporting, aggregate safety reporting, management of risk-benefit profiles, risk management and mitigation plans for all clinical stage programs

• Directly oversees the PV vendors/service providers to ensure that they fulfill their accountabilities and responsibilities, which includes ensuring high quality and on time case processing and aggregate reporting, as well as ensuring appropriate documentation and governance frameworks are in place
• Act as a sponsor Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) and provide input on case processing activities for 4DMT products
• Ensures that adverse events from spontaneous cases, solicited cases from studies and programs involving 4DMT products be collected, reported, and handled in accordance with global/local regulatory requirements and company policies
• Collaborate with appropriate clinical operations, clinical development, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues including authoring as appropriate and review of documents such as DSUR, IB, clinical study protocols, informed consent forms, DSMB charters/meeting materials, development plans, Safety Management Plans (SMPs) and INDs/CTAs
• Support SAE Reconciliation activities for all 4DMT ongoing studies

• Provide safety operations expertise to other 4DMT therapeutic functions
• Represent PV function in audits with health authorities and development partners
• In collaboration with QA, overseeing and support implementation of safety related CAPAs, as necessary
• Support development of training modules and provide training in Pharmacovigilance across the Company
• Other duties as assigned

QUALIFICATIONS:

• Experience in ophthalmology/gene therapy a plus

Education:

• RN or other clinical equivalent degree required with strong relevant work experience

Experience:

• 6+ years' experience in a Pharmacovigilance Operations role within the Pharmaceutical / Biotechnology industry
• Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations Previous experience managing PV vendors required

Skills:

• Good project management skills and the ability to manage multiple, diverse tasks and to prioritize tasks effectively is required
• Ability to work collaboratively with the internal partners and ability to build relationships with clinical sites and outside vendors

• The ability to work under pressure to meet deadlines, the ability to handle complex projects and to overcome delays and obstacles, and excellent team member and interpersonal skills are required
• Attention to details, able to proactively identify issues and propose solutions
• Excellent written and verbal communication skills

Physical Requirements of the Role:

• Sitting for prolonged periods of time working on a computer

Base compensation range:

Please note, the base compensation range and actual compensation offered to the final candidate is dependent on variety of factors: candidate’s geographical location, relevant work experience, skills, and years of experience.