Senior Drug Safety Associate
About the role
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- In this position, you may manage Clients or Project specific processes, associated with the entire medical information or adverse events process, which may include safety data collected from clinical trials and/or post marketing setting for specified projects or act as safety lead for multiple small/medium pharmacovigilance standalone projects.
- May monitor and manage project deliverables regarding contract assumptions; identifying out of scope work or potential to run over budget and escalate to upper management as needed; and provide necessary data to support Change Notification Forms and/or Change Orders.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations made to enable individuals with disabilities to perform the essential functions.
All regions: In depth relevant proven PVG experience, minimal 2 year's pharmacovigilance experience or other equivalent clinical or pharmaceutical experience.
*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, and working within safety database.
- Excellent understanding of global regulations are related to pharmacovigilance and safety processes
- Excellent computer skills (Microsoft Word, Excel, Outlook) and safety system proficiency
- Safety Database, or Medical Information System skills as applicable (Argus, Arisg)
- Excellent decision-making skills
- Excellent communication and conflict/relationship building skills
- Ability to lead teams and guide/mentor staff
- Excellent organizational, time management and problem-solving skills
- Strong sense of responsibility and ownership to deliver quality services
Application process
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Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
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Reasonable AccomodationsDay in the life
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