Deciphera Pharmaceuticals Inc.
Job Title: Pharmacovigilance Scientist
Job Number: 24327
Location: 500 Totten Pond Rd 6th Floor Waltham, MA 02451
The 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 PV Scientist is expected to be equally effective in working collaboratively or independently. She/he will support activities such as signaling, safety data analyses/authorship for ad hoc queries and aggregate reports and ensure that these 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 PV Scientist also supports to maintain and update SOPs and work instructions regarding signaling, ad hoc and aggregate safety and risk management reports as applicable. The successful candidate will have demonstrated adequate experience of the above responsibilities in their work. Accountability and a sense of urgency in supporting these 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.
- 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.
- Support PSUR/PADER/DSUR strategy and timelines with key stakeholders and vendor.
- Support RMP updates and REMS reports as appropriate.
- 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 2-3 years relevant medical, scientific/clinical, or pharmaceutical experience, including experience in drug safety serving in a PV Scientist or similar role.
- Advanced degree (PharmD, RN, MD, PhD, MPH, NP, MS)
- Demonstrated experience in analysis, 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
- Collaboratively, works on processes such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
- 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