Deciphera Pharmaceuticals Inc.
Job Title: Senior Pharmacovigilance (PV) Scientist
Job Number: 22448
Location: Waltham, MA
The Senior PV Scientist serves as a critical medical analytic and coordinating role in partnership with the Safety MD/Medical Monitor for investigational and/or marketed product(s). The Senior PV Scientist is expected to be equally effective in working collaboratively or independently. She/he must demonstrate effective leadership skills with cross functional partners to ensure that signaling, safety data analyses/authorship for ad hoc queries and aggregate reports are of high quality and are completed and submitted according to required timelines. For investigational products, this role may also participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB activities, coding review as well as SAE reconciliation activities. The Senior PV Scientist also plays a key role in ensuring that the above activities remain compliant with evolving regulations, that respective SOPs and work instructions regarding signaling, ad hoc and aggregate safety and risk management reports are adequate.
The successful candidate will have demonstrated successful mastery of the above responsibilities in their work. Accountability and a sense of urgency in leading/managing projects is a key success factor for this role. Demonstrated ability to review and analyze clinical data, be able to make assessments and be able to communicate effectively both verbally and in writing. Position will report to the Director/Senior Director of Pharmacovigilance
- Serve as key analytic and safety support lead in close collaboration with the product safety physician/medical monitor
- Responsible for signaling review and the coordination and documentation of all signal review activities with the product safety physician and product complaint staff. This includes performing signal investigations and drafting signal investigation reports.
- Manage literature review plan for product(s)
- Safety Committee preparation and documenting of meeting minutes
- Coordinate ad hoc safety query or health hazard evaluation response plan for analysis in conjunction with the safety physician, Biostatistics and others as needed, including performing analysis and drafting of query responses for review and finalization.
- For investigational product(s): safety review of protocol and CRFs, safety content of IB, ICF, and as appropriate support DSMB activities. Assist with lab and AE data review, associated with clinical study reports.
- Lead PSUR/PADER/DSUR strategy and timelines with key stakeholders and vendor. Support RMP updates and REMS reports as appropriate.
- Key safety representation in Integrated Safety Summary reviews, which may include narrative generation, review and approval for filing related activities.
- Keeping updated on relevant regulations associated with the above activities. Contributes to initiatives for process improvement and cross-product process consistency.
- Other tasks as assigned or required
- Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, including 3 years of experience in drug safety serving in a PV Scientist or similar role.
- Advanced degree (PharmD, RN, MD, PhD, MPH, NP)
- Demonstrated experience in analyzes, and interpretation of medical and scientific data and excellent verbal and written skills.
- Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
- Strong organizational, project management and leadership skills: Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. Oversees and mentors less experienced PV Scientist staff.
- Applies clinical judgment to interpret case information.
- Familiarity with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.
- Strong knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects) and Argus Safety systems
Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.