Sr Principal PV Scientist- Oncology
12 Month contract (Possible full-time conversion)
Cambridge, MA (On-site)
Your role in a nutshell:
- Seniority: Senior Principal (No direct reports)
- This business unit is specialized in oncology, so prior oncology experience is heavily preferred!
- Previous experience in drug development/pharma/biotech is essential.
- You will have the opportunity to create and deliver presentations!
- There is opportunity for a contract to permanent conversion after the 12 month contract, as there is an expected headcount increase in 2020 within this group.
- This role sits within a team that uses ARGUS.
- Culture fit is important! You would be working and communicating with people cross functionally on a global scale.
- It would be helpful if you have prior experience with Risk Management Plans and Statistical Analysis Plans
- No travel will be involved.
- Good writing skills are necessary, as you will be involved in revision of documents such as CSRs and investigative reports, as well as drafting Informed Consent Forms for patients.
- Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products. As appropriate and exceptionally, may be the lead safety support for a compound as the Global Safety Lead (GSL).
- Proactively facilitating pharmacovigilance activities for assigned developmental and/or marketed products in conjunction with or as the GSL
- Represent pharmacovigilance, both regionally and globally as an authoritative and knowledgeable member of Global Clinical Development Teams (GCDTs) and similar commensurate with position's seniority/experience and particularly when the designated GSL
- Closely involved in signal detection/safety monitoring activities for designated compounds/therapeutic area.
- Proactively develop functional & therapeutic area expertise
- Flexible outside of primary therapeutic area as directed by business and departmental need
- Appropriately experienced to undertake all usual Pharmacovigilance Scientist activities, including case report QC, review, follow-up reportability assessments and input into aggregate safety reports globally, with the flexibility of mindset this requires.
- The attainment of advanced compound expertise might, for exceptional individuals, allow for Global Safety Lead (GSL) responsibilities where the individual has demonstrated both the requisite depth of knowledge and associated advanced communication skills.
- Work with other relevant functional areas both within and outside of global PV to ensure efficient and timely attainment of compliant and patient focused safety data.
- Represent pharmacovigilance department in cross-functional teams and/or meetings at a regional and global level as required, alongside the commensurate communication skills required.
- In depth knowledge and understanding of designated products/studies. If the responsible GSL, will be the company's lead responder and source of expertise for safety related issues for designated compound.
- Build on knowledge and understanding of designated products/studies
- Regular interaction with scientist and physician colleagues under the auspices of the safety Therapeutic Area Lead (TAL), particularly when the responsible GSL.
- Provide support and oversight of pharmacovigilance operational activities for designated compounds, with lead responsibilities when acting as the GSL
- Help mentor new entrants/less experienced PV scientist colleagues.
- Involvement in facilitating safety procedures for developmental programs
- Contribute to safety exchange agreements for co-development projects
- Review and provide functional area expertise for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents
- Close knowledge of protocols to effectively respond to safety issues.
- Providing investigator and monitor training on safety procedures
- Participate in Global Safety Teams, coordinating all aspects of signal detection/safety review activities.
- Draft responses to regulatory/ethics safety questions
- Assist with writing and maintenance of the Safety Monitoring Plan
- Assist with set-up and running of DSMBs
- Close working relationship with physicians, both technically and managerially
- Perform ad-hoc analyses e.g. in response to regulatory queries
- Integral to Global Safety Teams and associated support
- Other functions as directed by departmental and business needs
- Proficient in all communication skills, with the agility to respond to different audiences in a clear and concise manner. Where acting as the GSL can expect to lead presentations to Safety Board, with the detailed preparatory work this implies and, where ad hoc issues arise, the short timelines that can ensue.
Education, Behavioral Competencies And Skills
- Bachelors required; Advanced degree in scientific/medical field preferred
- Excellent databases and coding skills including ability to perform advanced searches
- Detailed knowledge of clinical trial methodology, pharmacovigilance regulations, safety profile and risk/benefit analysis.
- Critical thinking and decision-making skills
- Ability to review, analyze, interpret and present complex data to a high standard
- Commitment to a global organization
- Excellent communication and presentational skills
- Good level of computer literacy
- Excellent organizational skills and ability to prioritize
Sthree US is acting as an Employment Business in relation to this vacancy.