Title: Senior Director Pharmacovigilance and Drug Safety
Introduction:
A leading pharmaceutical company based in New Jersey is seeking a highly skilled and experienced Senior Director of Pharmacovigilance and Drug Safety. This permanent position offers an exciting opportunity for the right candidate to lead end-to-end case processing while managing vendors & call centers. The successful applicant will be responsible for overseeing aggregate reports as well as signal detection.
Responsibilities:
As our new Senior Director of Pharmacovigilance and Drug Safety, you will be responsible for a wide range of tasks including but not limited to:
- Overseeing End-To-End Case Processing
You will be responsible for managing all aspects related to adverse event reporting including medical review processes. This will involve working closely with cross-functional teams such as clinical development, regulatory affairs, and medical affairs to ensure timely and accurate reporting of safety data.
- Signal Detection
You need previous expertise detecting signals from various data sources by using statistical methods. You will be responsible for overseeing signal detection activities and working closely with cross-functional teams to assess the clinical relevance of signals and determine appropriate risk management strategies.
- Aggregate Reports
You will be responsible for overseeing the preparation and submission of aggregate reports such as periodic safety update reports (PSURs) and development safety update reports (DSURs). This will involve working closely with cross-functional teams to ensure the accuracy and completeness of safety data.
- Risk Management
You must have experience creating risk management strategies that meet regulatory requirements such as REMS programs or other safety monitoring procedures. In addition, you will be responsible for identifying potential safety risks and developing appropriate risk mitigation strategies.
- Vendor And Call Center Management
In this role, you'll take charge of vendor selection & oversight which means ensuring compliance with global regulatory authorities. You will be responsible for managing relationships with external service providers such as contract research organizations (CROs), call centers, and safety database vendors.
Qualifications/Skills Required:
To be considered for this role, you must meet the following qualifications:
- MD Or Pharmd Needed For Role
- Relevant Experience As A Pharmacivgilence Director
Experience working within the Pharmaceuticals sector would be advantageous. You should have a minimum of 10 years of experience in pharmacovigilance, with at least 5 years in a senior leadership role.
- Strong Leadership Skills
You should have a proven track record of leading and managing cross-functional teams and external service providers.
- Excellent Communication Skills
You should have excellent communication skills, both verbal and written, and be able to communicate complex safety information to a wide range of stakeholders.
