Executive Director Drug Safety
Proclinical is currently recruiting for an Executive Director of Drug Safety with a clinical-stage research company located in Cambridge, MA. As the Executive Director of Drug Safety, you will establish PV operation capability in (outsourced) case processing - specifically of US post-marketing case processing, (outsourced) production of quality documents like DSURs and RMPs, risk assessments
- Lead global medical pharmacovigilance activities, operations, and risk management strategies in alignment with US, EU and ICH regulations
- Have oversight of vendors and their processes and output
- Build, lead, and support the operations of a global function supporting development, through NDA/MAA filings, to approval and post-marketing
- Facilitate cross-functional Safety Surveillance Team meetings; includes coordinating materials, data presentation and all outputs, and agenda
- Responsible for medical-safety sections of aggregate safety reports (DSUR, PSUR)
- Provide subject matter expertise and input for regulatory submissions, e.g., NDA, regulatory responses
- Provide support - in collaboration with Medical Science - for safety sections of clinical documents including the review and approval of the safety portion of protocols, annual reports, final study reports and other as needed
- Implement, execute, and maintain safety processes and systems that conform to the company's business strategy, industry standards and comply with global regulations
- Further build the quality management system for PV including policies and SOPs
Skills and Requirements:
- MD, PhD, or MSc with science background
- 10+ years of hands-on pharmacovigilance experience for a pharma/biotech company
- Strong background in PV operations, case processing, and US post-marketing PV activities.
- Deep understanding of regulations, knowledge and practices required for pharmacovigilance, e.g. ICH guidelines, international pharmacovigilance regulation, industry practice with a focus on the US; however, knowledge and experience with EU regulations is strongly preferred
- Strong written and verbal communication skills.
- Good team player
- Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes.
If you are having difficulty in applying or if you have any questions, please contact Nicole Aganon at (+1) 347-293-1161 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.