The Director of Pharmacovigilance will oversees all safety operations activities with clear accountability for goal setting and execution of those goals in line with the departmental strategy. The Director of Pharmacovigilance will also manage the day-to-day functioning of the safety operations department. He or she will ensure the timely processing and submission of adverse event reports in compliance with global regulations for marketed products and company-sponsored clinical trials. The pharmacovigilance team will process, handle and exchange all relevant safety data from partners, alliances and investigator-sponsored studies, supporting scientific and clinical teams. The Director of Pharmacovigilance also collaborates with other applicable user groups on safety operational matters.
Our early stage pharmaceutical clients seek drug safety and pharmacovigilance MDs or PharmDs who are detail and safety oriented and have strong leadership skills. It is important that they have a track record of accomplishment in managing a comprehensive drug safety program. Our companies offer excellent career growth potential, and excellent benefits. We have many opportunities - all with top companies seeking the best in pharmacovigilance leadership.
typical roles and responsibilities for Director of Pharmacovigilance
- Lead the evaluation and change management of the drug safety and pharmacovigilance team
- Oversee adverse events case investigations and reporting ensuring that all safety reports received from any source are processed and reported according to appropriate regulatory requirements and company processes.
- Ensure compliance with safety data reporting for all company products per the appropriate regulatory requirements
- Oversee that all drug safety case reports from clinical studies, post marketing sources, partnered programs, and any other sources are received
- Develop and recommend changes to procedures, ensuring adherence to those procedures
- Manage communications with and provide oversight to partner companies and CROs regarding the evaluation processing of case reports
- Oversee the standardized set-up of new safety projects, including development of safety management plans and set-up of safety systems
- Assist in the negotiation of safety exchange agreements with license partners in support of process definition, monitoring and other roles ensuring operational timelines can be met
- Oversee the production and validation of appropriate safety data output from the safety database for required safety deliverables
- Manage the process for identifying, evaluating, selecting and managing outsourcing vendors involved in safety data activities including CROs, call centers, safety database vendors
- Supervise drug safety and pharmacovigilance services outsourced to contract research organizations, independent contractors, and other vendors
Requirements for the Director of Drug Safety / Pharmacovigilance
- Bachelors’ degree in life sciences; PharmD or MD
- 10+ years' drug safety experience.
- 2+ years of supervisory experience in drug safety / pharmacovigilance
- Excellent leadership and communication skills
- Proven ability to manage multiple competing projects
- Advanced working knowledge of drug safety regulations and guidance (FDA, ICH, EU GVP)
- Demonstrated proficiency with Argus data input, MedDRA coding and ARISg, and Microsoft Office programs (Word, Excel, PowerPoint, Outlook)
- Hands-on experience using literature search tools and databases