Head of Drug Safety

The Head of Drug Safety is critical to insuring your product achieves and maintains regulatory approval. This person is responsible for all Safety Evaluation and Risk Management (SERM) and Pharmacovigilance (PV) activities.

Contribution to Business Success

A strong Head of Drug Safety can make a significant contribution to a company’s long-term financial success. They will review individual safety reports beginning in Phase II and will contribute to Phase III safety sections of regulatory applications. They will set up and run safety and pharmacovigilance operations if none exist, most likely using cloud-based systems popular in the drug safety community. An outstanding Head of Drug Safety will keep operations lean until their clinical-stage company is sold, at which point safety operations will be folded into the acquiring company and it’s software systems.

These things save the company significant money, not usually realized until the end of the regulatory approval process.

Major Achievements (examples)

  • Established Safety Committees
  • Implementation of safety monitoring systems and software.
  • Efforts resulted in the end of a FDA study hold.
  • Developed country-specific Risk Management Plans
  • Lead publication of multiple Drug Safety Update Reports (DSURs) or Periodic Safety Update Report (PSUR) or Periodic Benefit-Risk Evaluation Report (PBRER)

Potential Pitfalls

  • Poor quality safety data.
  • Poor understanding of safety data.
  • Missed internal or regulatory agency deadlines.
  • FDA requirements not anticipated.
  • Not meeting regulatory requirements. Examples include early release of data, failure to ensure patient confidentiality, incomplete regulatory submissions and failure to understand the different requirements made by each regulatory body (FDA, EMA, PDMA, etc..).
  • Poor ethical decisions.
  • Studies being put on clinical hold and FDA having a significant amount of follow up questions, which will require additional time, money and resources to answer.
  • Turnover of staff on the safety team is worse than the rest of the company.
  • Not building strong working relationships with the FDA, IRB and contributors to regulatory submissions (IND, NDA, PMA, IDE, etc) such as the Chief Medical Officer, and heads of Quality, R&D or Biostatistics.

If your Head of Safety has hit more than one of these pitfalls it may be time for a confidential search.


MEIRxRS aims to provide three top-notch candidates in 21 business days. We vet candidates closely, interviewing them, checking with their peers and assessing each candidate for abilities to help you achieve your business objectives.

Strong candidates for a Head of Drug Safety will not be trolling job boards looking for their next position. They will be too busy avoiding potential pitfalls above and contributing to their business’s success. Generally, they will be working diligently towards insuring patient safety. Your company may have to wait a few months until a strong Head of Drug Safety with the proper boards and therapeutic expertise comes along, so it’s best to start the search process as early as possible. Your company may want to use a consultant until a replacement starts.

Confidential Searches

Your company may wish to conduct a confidential search through MEIRxRS for a number of reasons. One is to keep a faltering leader on the job until a replacement can be found. Second is that the candidate pools for such position may be small and your company may not wish for its competitors to know that you may be interviewing their employees.

Retained Searches

Retained searches are less expensive if you are committed to filling a position. A portion of the fee is paid up front, a second payment is due during the interview stage and the final payment is due after the candidate starts work. Your retained search gets first priority over contingency searches.

Contingency Searches

Companies sometimes engage multiple agencies concurrently in an effort to speed the search up. Unfortunately, this results in a barrage of agencies submitting poor-quality resumes in an effort to get their candidates in first (and earn the fee) in case they are good. Resumes may be submitted even if the candidate hasn’t been interviewed or told that their resume is being submitted to your company. Recruiters place multiple calls and emails to get the resume in first, diverting attention of hiring managers from their other responsibilities. All this undermines our goal of providing top-notch candidates for our clients. Because of this MEIRxRS will not conduct a contingency search if other agencies are working the search at the same time.

Requirements for a Head of Drug Safety

A PharmD or medical degree and board certification (MD or DO) is usually required. Current knowledge regulations (local,and global) for drug safety and pharmacovigilance practices is also a must. As is hands on experience with guidelines for AE/SAE reporting, conducting clinical research, and ICH/GCP practices. Relevant therapeutic experience is generally preferred, sometimes required. Preclinical and clinical-stage companies need previous experience drafting safety sections for regulatory filings because of their shorter timelines and reliance on investor funding.


  • Establish, oversee and lead Safety Evaluation and Risk Management (SERM) and Pharmacovigilance (PV) activities
  • Medical review of individual safety reports and emerging safety data (signal detection)
  • Analyse safety data from on-going and completed clinical trials and presentation in Clinical Study Reports (CSRs)
  • Facilitate production and maintenance of risk management plans and safety communication to regulatory agencies or third parties.
  • Participate in continuous improvement activities including systems design, performance measurement and quality management.
  • Work with external partners, e.g. CROs

Suggested Readings

  • Books on Leadership, Project Management, Regulatory Writing, and Business Writing


If you would like to be confidentially contacted when we have a relevant Head of Drug Safety search please contact a talent manager today.

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