Senior Director, Drug Safety & Pharmacovigilance
Location: New Jersey - Hybrid
Salary: $240,000-$280,000 + Bonus
A Commercial stage pharmaceutical company is seeking to add a Senior Director of Pharmacovigilance to their team. The company is a large, international pharmaceutical manufacturing firm, specializing in producing essential generic medicine that is affordable. This is a U.S based company also seeing massive international success.
This person will be the pharmacovigilance expert in the firm, overseeing full scale strategy to the entire safety department across the company. The role works in tandem with clinical and medical affairs and reports issues to executive leadership. The Senior Director will ensure FDA regulations are met, as well as all aspects of signal detection and risk management.
Duties and responsibilities:
- As the leader of the Global Patient Safety team, responsible for all aspects of pharmacovigilance, including the management of cases from intake call centers, quality complaints triage, adverse event and medical inquiry case processing, and the generation of post-marketing surveillance aggregate reports for drugs and Medical Device Reports for combination products, as well as handling safety-related queries.
- Analyzes and assesses safety signals by examining individual case safety reports and trends in aggregate safety reports. Facilitates the development and maintenance of product risk-benefit profiles and actively seeks opportunities for innovation and continuous improvement in drug safety surveillance.
- Collaborates with colleagues from partnership companies in Global Patient Safety to establish compliant Safety Data Exchange Agreements.
- Oversees external vendors providing support for the Argus Database, Medical Information Management Software, and Pharmacovigilance/Call Center assistance.
- Conducts health hazard assessments for quality-related issues.
- Ensures adherence to departmental SOPs in a compliant manner.
- Reviews product labeling for any safety-related modifications.
- Reviews safety-related sections of clinical protocols and addresses potential safety concerns during the conduct of clinical studies.
- Manages projects by coordinating the efforts of the drug safety and Pharmacovigilance team members, and if required, contractors, to ensure deliverables meet internal quality standards, comply with FDA and other regional Regulatory Authority regulations, are completed within specified timelines, and stay within the allocated budget.
Qualifications:
- Medical Doctor degree OR Pharm D
- 10+ years of drug safety experience with Risk management and managerial experience
- Problem solving skills
- Proficiency in Microsoft office
- Understanding of global regulatory requirements
