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Head of Drug Safety & Pharmacovigilance
  • Job type: Permanent
  • Location: San Francisco, California
  • Salary: Negotiable
  • Description Head of Drug Safety & Pharmacovigilance Head of Drug Safety & Pharmacovigilance San Francisco, California A late-stage biopharmaceutical company focused on discovering, developing

Drug Safety, or Pharmacovigilance, focuses on the detection, evaluation, and prevention of adverse effects of drugs. A drug safety professional is involved in drug safety management such as medical supervision, conducting clinical trials, SOPs (standard operating procedures) and keeping a check on all the applicable regulations. Some also work in co-ordination with chief medical directors.   
A drug safety professional monitors all the post-marked products, ensuring that they’re safe for use. A safety officer is involved in carrying out assessment of adverse event writings, conducting quality checks on write-ups produced by other drug safety officers, writing reports on safety, and handling drug related case reports.

Job Specification, Salary, Outlook
The primary responsibilities of drug safety specialists include participation in the processing of individual case safety reports (ICSRs), quality reviews, and overseeing certain activities that are performed by contract research organizations. Additionally, they will participate in process improvement activities such as updating or developing job aids and/or standard operating procedures. Depending on their role and experience, they may also work on other tasks, including preparation of NDA safety updates, annual reports and safety reports, and liaising with investigators.
So how much do drug safety professionals earn? It depends on several factors, but the average salary for software engineers in the United States is $67,595 per annum, with a range of $43,466 - $103,755. Factors that affect the level of salary of a drug safety professional include job location, technical skills, on-the-job experience, and academic background. In the UK, an average salary of £27,531 per year can be expected, with a range of £18,399 - £53,327.  

Job Description
A drug safety professional plays an important role in the drug lifecycle. You may be involved role in assessing the risk/benefit of products to ensure that they are safe to use. Drug safety professionals are often responsible for creating medical reports required by Food and Drug Administration bodies, and may also provide demonstrations on safety regulations, and perform auditing duties. Other tasks include reviewing the available information on adverse events and facilitating the discussions as necessary on these events with healthcare workers and other relevant professionals. Drug Safety cases can come in from medicines actively being marketed or from clinical trials. Once a side effect is reported in the company database, additional follow ups may be required to complete any gaps in the case. The completed reports are then sent onto the regulatory authorities for review.

Typical Responsibilities: 

  • Drug Safety / Pharmacovigilance (PV) Specialists are primarily engaged in case creation, reviewing the initial case for minimum safety information e.g. a reporter, a patient, an adverse event and a suspect medicine 
  • Coding adverse events in the available safety database
  • Data entry of all details available into the safety database
  • Reviewing and assessing all source documents and data in an event report
  • Writing and processing of adverse event program
  • Executing labeling evaluation of events
  • Following up and tracking crucial case reports
  • Conducting pharmacovigilance developments and supervising the processes
  • Acting as a link between the patients and company or healthcare experts, to provide information on product safety 
  • Attending meetings related to product safety
  • Supporting the generation and distribution of aggregate safety reports
  • Contributing to various process improvement activities, including drafting new job aids/SOPs and updating existing job aids and SOPs 

Key Skills & Qualifications     
Generally, a bachelor’s degree in science, pharmacy, life sciences or medical degree is required. In some cases, a Masters in Drug Safety, or project management qualifications are required or beneficial. Drug safety specialists should have good interpersonal and communication skills, as well as being able to work well on their own with minimal supervision, and have meticulous attention to detail.  

Required job skills

  •  Working knowledge of relevant ICH, EU, FDA guidelines, regulations and initiatives governing processing for clinical trial environments and safety reporting 
  • Knowledge of MedDRA dictionary with relevance to SAE coding and SAE analysis or reconciliation (desirable) 
  • Experience with common safety databases (e.g., Argus, AERS, Arisg, etc.) 
  • Solid verbal and written communication skills
  • Excellent proficiency in various computer applications such as MS Word, Excel and PowerPoint, and a willingness to increase and expand necessary competencies
  • Comfortable speaking with study/site personnel
  • Self-motivated and a committed team player
  • Superior problem-solving skills
  • Ability to meet internal and external deadlines
  • Primary oncology knowledge (desirable)
  • Meticulous attention to detail

Job Trends  
Drug Safety is an excellent employment option for medical, pharmacy and life science graduates. Drug Safety has a clear career path with the potential to work in both permanent and contracting positions. Depending on the level of experience gained, career progression can move towards line management, or in a more technical direction which includes signal detection, epidemiology and risk management.