Principal Pharmacovigilance Safety Study Coordinator

Description

Step into a key role at Boehringer Ingelheim as our next Principal Study Coordinator. Drive the integration of patient safety across clinical studies, streamline data processes, and enhance collaboration within our clinical and post-marketing teams. Utilize your technical skills to support and improve pharmacovigilance operations and cross functional processes. If you're passionate about advancing healthcare from within, we want you. Join us in shaping the future of patient care.

This position can be filled in different countries.

If you want to apply for the position in Germany, please use this link: coming soon

If you want to apply for the position in the US, click "Apply now".

Duties & Responsibilities

• Leads cross functional working groups and discussions and steer development of user requirements for both BDS systems as well as PSPV systems.
• Provides strategic input about processes, landscape of interfaces and common topics and issues and provides solutions that ensure efficient and effective processes as they pertain to safety topics in clinical studies.
• Give input in other functions' SOPs and drive changes in the interfacing areas with regards to PV processes that affect them. Ensure consistency and process improvements (including system to system automations) with respect to data handling (including reconciliation and end of trial unblinding activities).
• Leads discussions between PSPV, Clinical Operations, Biostatistics and Data Science (BDS) in the set up and maintenance of clinical studies and ensure patient safety aspects are included in the trial protocol and in the processes of these functions.
• Communicates, collaborates and when required provides training as appropriate to internal and external (CRO) groups who collect and transfer adverse event information to PSPV. Interface with PSPV patient safety physicians in all those tasks.
• Ensure safety management plan set up with suppliers and BDS.
• As necessary program and implement tools, e.g. access databases and SAS programs to ensure efficient and effective processes in the Study Coordination team.
• Performs tasks as they pertain to clinical trials that are part of other job profiles in Global case management. This can include medical review of clinical trial cases, quality checks of clinical trial cases or reconciliation.

Requirements

• Bachelor's degree required, and in addition fulfill one of the following education levels:
  o Advanced degree (PharmD, NP, PA, Master's, M.D., DO, Ph.D.)
  o Combined BSc. with a MBA, or BSN with an MBA
  o Other medically qualified licensure (e.g., RPh, Respiratory Therapist)
• Five (5) years or more experience in the pharmaceutical industry, preferably focused on pharmacovigilance and clinical research (i.e. medical documentation specialist, clinical research associate (CRA), study nurse, other health care specialist or other comparable medical background)
• Proven proficiency in analytical software's and technology, such as SAS, R, or Python
• Knowledge of international regulatory requirements within Pharmacovigilance and study activities
• Ability to solve complex problems and take decisions independently.
• Ability to prioritize workload and perform under stress in situations in which working speed and sustained attention are critical aspects of the job.
• Application of medical knowledge to collect, interpret and reconcile medical information to precisely capture the adverse event as reported.
• Must be able to communicate and resolve issues effectively with inter/intra departments through strong interpersonal skills.

Compensation

This position offers a base salary typically between $140,000 and $222,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here .