Job Title: Associate Director/ Director Drug Safety and Pharmacovigilance (DSPV)
Reports To: Sr. Director of Drug Safety and Pharmacovigilance
Location: Boston, MA
A broad-based pharmacovigilance role including oversight of outsourced case processing activities, oversight of business partner safety activities, coordination of vendor/sponsor safety surveillance activities, participation in pharmacovigilance system and pharmacovigilance quality system buildout prior to filing for marketing approval
What makes this role special:
- Seek to have a profound impact on young children and their families
- Potentially be part of the first launch of a medicine for a rare pediatric liver disease
- Work on a portfolio of multiple potential therapies
- Gain a rare diversity of commercial experience
- Develop strategy, as well as manage execution
- Help shape the culture and future of an emerging biopharma with a big vision
- Collaborate with a small, collegial team of good people
- Learn from leadership with deep experience and a history of success
- Be part of an early biopharma company in an excellent financial position
- Enjoy great work/life balance, including flex hours, ability to work remotely on Friday’s, generous holiday schedule and business-casual work environment
Responsibilities (may vary):
This description is not intended to provide an all-inclusive listing of duties and responsibilities. Duties may change at the discretion of management, and/or management may request duties be performed that are not listed. This job description is not a contract of employment and does not change your status as an at-will employee.
Key Duties and Responsibilities:
- Provide sponsor oversight for outsourced drug safety and pharmacovigilance activities performed by third-party vendors. Outsourced activities include:
- Case processing activities
- Safety surveillance and signal detection activities
- Periodic report (DSUR/PSUR) development and distribution
- Maintenance of key documents and submission and activity tracking systems
- Oversee business partner safety relationships as required
- Collaborate with marketing partner(s) in the exchange of safety information, ensuring compliance with the safety data exchange agreement and pharmacovigilance regulations
- Represent DSPV on clinical development teams
- Review relevant sections of study budget
- Oversee safety components of study setup, including safety database setup, CRF review and key document creation
- Participate in the quality review of SAEs and SUSARs following data entry by vendor, including data accuracy, narrative quality, MedDRA coding, and appropriateness of follow-up safety queries.
- Provide ongoing safety oversight as required, including support for database lock activities for SAEs
- Participate in the buildout of the Pharmacovigilance System
- Work with vendor in the development of the Risk Management Plan
- Participate in the creation and maintenance of the Pharmacovigilance System Master file
- Establish relationships with Qualified Persons for Pharmacovigilance
- Participate in the buildout of Postmarketing adverse event collection
- Participate in the development of the PV Quality System in preparation for filing for marketing approval
- Participate in quality oversight ensuring department standards are met, including training requirements, monitoring vendor performance and implementing continuous improvement actions
- Monitor compliance with regulations, PV agreements and internal SOPs
- Participate in Data Safety Monitoring Board activities, including provision of safety information for DSMB meetings and interim reviews
- Participate in authoring and QC of periodic safety reports (e.g., DSUR, PSUR, PADER)
- Works with QA department to maintain a state of high PV inspection readiness across all regions/countries.
- Participate in internal audits and global regulatory inspections including MHRA/FDA/EMA etc. as a SME for specific PV topics and processes.
- Contribute to formal responses to inspection and audit findings related to DSPV department.
- Manage and develop DSPV staff as appropriate
- Assist in performing additional ad hoc activities as assigned.
- Bachelor’s degree in nursing, pharmacy, or other health care-related profession or life sciences preferred or equivalent qualification/work experience.
- Minimum of 7 years of experience in Drug Safety/Pharmacovigilance in a pharmaceutical industry setting or the equivalent.
- Minimum of 4 years of experience working with third-party Pharmacovigilance vendors, CROs, and business alliance relationship management.
- Global pharmacovigilance operations experience with marketed products and/or products in development.
- Knowledge of relevant ICH, FDA, EMA, and PMDA Guidance and Regulations governing adverse event processing and reporting from clinical trials and/or post-marketing surveillance.
- Experience working with safety databases and systems (Aris Global preferred)
- Experience with MedDRA coding and data entry.
- Experience with authoring periodic reports preferred but not required
- Experience with safety surveillance and safety signaling activities preferred but not required
- Proficient with Word, Excel and Powerpoint
- Strong analytical and problem-solving skills with superb attention to detail.
- Strong verbal, written technical communication and presentation skills.
- Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
- Proven ability to work within a cross-functional, matrixed team with the ability to manage multiple tasks with competing timelines.