Vice President - Drug Safety & Pharmacovigilance

Title:                                 Vice President, Drug Safety & Pharmacovigilance
Reports To:                      Chief Medical Officer
Location:                          Redwood City, California
Classification:                  Exempt

Overview:   

The VP, Drug Safety and Pharmacovigilance provides strategical and operational leadership and management for all pharmacovigilance activities for globally marketed products and clinical drug safety evaluation/reporting for clinical trials sponsored by Coherus.  The Head of PV is responsible for ensuring that the safety systems and procedures are in place to support an outsourced global pharmacovigilance system, as well as, for ensuring compliance with on-going safety evaluations and reporting to regulatory agencies. 

Responsibilities:

• Responsible for leading the creation of the Global Pharmacovigilance and Clinical Drug Safety groups including: resources, strategy, goals and objective and maintaining the highest level of quality and regulatory compliance.
• Responsible for building Global PV and Clinical Drug Safety groups as appropriate to CHRS pipeline, need and budget.
• Responsible for coaching and developing PV staff by providing an environment that encourages ongoing personal and professional development.
• Accountable for assessment of performance of PV staff against CHRS PV and Clinical Drug Safety processes (SOPs), standards and performance goals, and for ensuring successful completion of all training required for each role. Responsible for process and performance improvement plans for global PV staff as needed to achieve department standards.
• Provide oversight of the global pharmacovigilance system (outsourced to CRO).
• Collaborate with Quality Compliance and other Clinical Science/Regulatory departments to ensure PV and clinical drug safety SOP and procedures are in place and reviewed and updated as necessary to ensure compliance with global pharmacovigilance requirements.
• Ensure regular communication with PV team at CRO and with the QPPV or designee from the CRO.
• Oversee the performance of the CRO and Partners with respect to managing database, reporting safety trends, reporting SAEs and AEs of Special Interest appropriate for indications and product.
• Ensure implementation of local and global safety strategy including maintaining awareness of new and emerging safety concerns and related communication to competent authorities in a time frame appropriate to the benefit-risk assessment in the applicable areas.
• Implement new safety initiatives and new Health Authority safety requirements as appropriate for CHRS to support global safety strategy.
• Provide input into responses to inquiries from regulatory authorities or health care professionals on drug safety issues.
• Participate in the development of and updating of safety information to the core data sheet, the investigator’s brochure (IB), label, risk management plan (RMP), and other safety documents for CHRS products.
• Pharmacovigilance is responsible to support and manage quarterly Executive Safety Review Committee meetings, coordinate post marketing surveillance and pharmacovigilance activities.
• Collaborate with other departments (e.g., Regulatory, Medical Affairs, Marketing, Clinical Operations, Drug Supply, Clinical Science personnel) to provide expertise and guidance to personnel regarding good pharmacovigilance and clinical drug safety practices.
• Interact with other PV units (e.g., Partners, CROs, vendors) to address safety queries, share best practices, and discuss new safety regulations.
• Responsible for overseeing Clinical Drug Safety and building group as appropriate to CHRS size and needs.
• Review all Informed Consent Forms are consistent with IB and originator molecule global safety information.
• Support Clinical Operations and Clinical CROs in all of the Data Safety Monitory Committee meetings.
• Meet with internal and external medical monitors for each clinical study to ensure best practices, review safety information and consistent responses to investigators across study sites on a regular and as needed basis.
• Review all CIOMS for accuracy, completeness and ensure timely closure as appropriate.
• Assist Regulatory and Clinical Operations as necessary with filing SUSARs, DSURs, and other required responses to Regulatory authorities and IRBs to maintain compliance with GCP and regulatory guidelines.
• Participate in protocol and CSR reviews.
• Participate in Clinical Science/Regulatory meetings as appropriate for PV and Clinical Drug Safety Role.
• Participate in Sr. Staff Meeting and Quality Review Committee meetings per agenda requirements.

Requirements:

• MD, RN, BSN, Nurse Practitioner, Pharmacist (PharmD) or related degree
• Minimum fifteen (15+) or more years Pharmacovigilance experience with at least five (5) years of department leadership/management experience
• Experience in safety document and medical writing including experience coding with MedDRA and WHO dictionaries in preparation of these reports preferred
• Excellent understanding of clinical trial methodology, GCP and medical terminology
• Attention to detail and quality focused
• Strong organizational and project management skills
• Strong negotiation and ability to operate effectively in an international environment
• Excellent understanding of physiology, pharmacology, clinical study objectives, and the drug development process
• Strong technical and problem solving skills
• Excellent presentation and communication (listening, forming ideas, speaking, writing and formal presentation) skills
• Strong computer skills, including but not limited to, Excel, MS Word, Please Review editing, MS Power-point or other presentation applications, and safety database applications
• Ability to work independently in a face-paced environment
• Demonstrating initiative and flexibility through effective innovative leadership
• Welcomes new ideas and constructive criticism
• Agrees with CHRS core values and mission
• Proven leadership skills in a cross-functional global team environment

The Base Salary Range for this position is $275,000 - $350,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.

Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.