Head of Pharmacovigilance, Region US
Job Title: Head of Pharmacovigilance, Region US
Job Type: Permanent
Site/Office Location: New Jersey
The LRC is currently supporting a leading speciality pharmaceutical organisation in their search for a Head of Pharmacovigilance, Region US.
The position would suit a seasoned professional looking to take the next step in their career. You will be pivotal in the creation of a safety strategy for their innovative products in development and help to start the next chapter in this highly successful businesses ventures.
The company is a global leading speciality pharmaceutical organisation that has recently transitioned into developing their own innovative products. Their pipeline is one to rival some of the top pharmaceutical companies out there, as they have late stage monoclonal antibody therapies in oncology, immunology and respiratory therapy areas.
As the Head of Pharmacovigilance, Region US, you will primarily be responsible for the management and efficiency of the US Pharmacovigilance operations, including the medical operations. You will have full responsibility over safety strategy for the assigned regions.
• Lead the Pharmacovigilance function in the US and assigned affiliate states (Canada, Latin America)
• Set out, and implement, the safety across the innovative product line to ensure smooth development processes.
• Ensure the process set forth by Global Pharmacovigilance including ICSR(s), Aggregate Reports PSUR, DSUR) are written & reported to respective regulators with maintaining the highest level of compliance
• Perform review of Aggregate Reports and Safety Surveillance documents
• Train & support the Local Pharmacovigilance Responsible Person for specific region to perform PV activities in their respective countries able Pharmacovigilance
• Manage an immediate team of 6 with further dotted line reports
• Medical qualifications with 10+ years experience in Global Pharmacovigilance
• Experience dealing with multiple health authorities, (FDA, EMA, MHRA)
• Proven track record in leading Pharmacovigilance departments
• Experience with Oncology, Immunology or Respiratory products would be a bonus, especially with Monoclonal Antibodies
To apply for this role please contact us at:
- Gideon Winton
- +44 203 640 2134
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