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Vice President - Drug Safety & Pharmacovigilance

Coherus BioSciences
Redwood City, California
Start date
May 13, 2023

View more

Administration, Clinical, Drug Safety/Pharmacovigilance
Required Education
Masters Degree/MBA
Position Type
Full time
Biotech Bay

Job Details

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


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. 



  • 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.




  • 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.  



Coherus is focused on expanding patient access to important, cost-effective medicines and delivering significant savings to the U.S. healthcare system. Every member of the Coherus team is dedicated, motivated, and passionate about expanding patient access to lifesaving therapeutics. Our colleagues are experts in analytical and process sciences, deeply experienced in clinical development and regulatory affairs, and have proven commercial and marketing capabilities. Everyone at Coherus is committed to meeting the highest standards, inspiring our teammates, and achieving our goals.

Coherus was founded a decade ago to provide the highest quality biosimilar treatments to patients. We are proud to now be expanding our legacy—to build on our success with biosimilars and to focus our core strengths on immuno-oncology.

At Coherus, our employees are our most important asset. We have a dynamic and rewarding organizational culture that offers the opportunity to work with leading industry professionals who are dedicated to making a difference for patients. We are looking for individuals who see unlimited potential in themselves and are motivated by a continuous passion for breaking down barriers and expanding access to lifesaving therapeutics.

Coherus offers a competitive total rewards program comprised of various elements, including competitive base pay, short- and long-term incentives in the form of performance-based cash and equity, as well as health and wellness benefits that include

•    Healthcare: Coherus pays 90% of premiums for medical, dental, and vision coverage for our

     employees, their eligible spouses, dependents, and domestic partners.
•    Health Savings and Flexible Spending Accounts
•    Group Life, Disability, and Group Accident Insurance
•    401(k) with company match, and an Employee Stock Purchase Plan (ESPP)
•    Paid Time Off (PTO) 
•    Health & Wellness programs, including a Health Club Reimbursement and an Employee Assistance Program

Health & Wellness programs, including a Health Club Reimbursement and an Employee Assistance Program

In addition to providing attractive rewards packages, we encourage and support our employees to find the right balance of work and personal time. Coherus offers a variety of activities, perks, and holidays that encourage employees to have a healthy outlook, spend time outside of work with friends and family, and foster a productive and collaborative work environment. Our culture is one in which we challenge and support all our team members to do their best work.

For more information about Coherus, please check out:

Find Us
333 Twin Dolphin Dr, #600
Redwood City
United States

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