Manager, Drug Safety Operations


Department:  Drug Safety Operations

Reports To: Sr Manager Global Case Processing & Submissions

Education Required: 

  • Bachelor’s degree (health care professional preferred, e.g. nurse, pharmacist and etc.), and at least 7 years of Drug Safety experience.
  • Relevant experience in global Drug Safety case processing, with preference for clinical trial safety experience
  • Experience using a drug safety database (e.g. ARISg or Argus)

General Description: 

Assist in the oversight of CRO responsible for global SAE case processing and submissions

Essential Functions of the job:

  • Assist with oversight and management of safety vendor to ensure timely SAE case entry, processing, notification to business partners, and expedited report submission and tracking.
  • Monitor different project related safety issues, facilitates group meetings, and follows up on action items/initiatives to ensure safety actions are addressed.
  • Assist in the review of Safety Management Plan (SMP), protocols and any other study related documents with a safety component
  • Support the management of communications and timelines with applicable partner companies and respective CROs regarding the intake, case processing, medical review and global submission of ICSRs as well as global safety aggregate reports (e.g.; DSURs, PSURs/PBRERs)
  • Assist with establishment and ongoing review of key performance indicators for the safety CRO
  • Collaborate with cross-functional stakeholders (eg; study/safety CROs, other departments) on any late report corrective and preventive action (CAPA) plans in order to address delays in reporting on a timely manner
  • Liaises with various external and internal groups to maintain a high level of quality and consistency across functional teams on best practices and industry standards
  • Participate in training the investigators, CRAs and CROs on SAE reporting obligations and study kick-off meetings
  • Act as an ad hoc Safety Operations representative to Clinical Study Teams (CSTs) with respect to safety data/process updates
  • Collaborate with the PV & Drug Safety team in the development of Drug Safety SOPs
  • Support PVDS on GxP audits (internal and external) and inspections.
  • Attend weekly and ad hoc meetings with the safety CRO
  • May provide back up support to the Senior Manager Drug Safety Operations
  • Maintain currency with evolving international guidance and regulations for global safety reporting, safety surveillance and risk management in both a clinical and post-marketed setting (FDA, EMA CFDA/SFDA, and other Asia/Pacific territories)


  • Organization and Analytical skills.
  • Expert time management skills, with the ability to prioritize workload
  • Quality orientation: attention to detail, accuracy.
  • Project management and multitasking skills.
  • Excellent global pharmacovigilance knowledge base
  • Self-motivated and capable to work independently

Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently.  Completes administrative tasks correctly and on time.  Follows instructions and responds to management direction.

Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations.  Writes clearly and informatively.  Able to read and interpret written information.

Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed.  Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment.  Manages competing demands.  Changes approach or method to best fit the situation.  Able to deal with frequent change, delays, or unexpected events.

Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management – Communicates changes and progress; Completes projects on time and budget.

Other Qualifications:

  • Relevant experience in clinical trial SAE case processing & SUSARs
  • Experience using a drug safety database (e.g. ARISg or Argus)
  • Working knowledge of FDA, EMA and other international pharmacovigilance and clinical safety regulations and guidelines
  • Familiarity with the content of standard pharmacovigilance documents such as SOPs, guidelines, safety plans
  • Ability to independently identify problems and effectively offer solutions
  • Excellent written, oral communication, personal organizational skills and resourcefulness
  • Ability to work collaboratively as part of a team in a fast-paced challenging environment
  • Proven proficiency using MS Word, Excel, PowerPoint and Outlook

Travel:  Less than 10%

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