Principal PV Scientist (Oncology)
Remote or Greater Boston Area
A highly successful global biopharma organization are seeking Principal PV Scientists to join their rapidly expanding team! The opening will sit on the Oncology team. This organization's PV group is planning to expand their headcount by a minimum of 10 positions in 2021, and these roles are apart of that initial expansion! There are also immense growth opportunities to develop into a Global Safety Officer, Director of PV Risk Management, or even to take on a new therapeutic area. If interested in learning more don't hesitate to apply!
The Principal PV Scientist will be responsible for:
- 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)
- Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed products
- 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 pharmacovigilance operations with a lead responsibility if the designated GSL
- Provide functional & therapeutic area expertise, supporting less experienced colleagues and the safety effort more generally
- Flexible outside of primary therapeutic area as directed by business and departmental need
- Assist with writing and maintenance of the Safety Monitoring Plan
- Assist with set-up and running of DSMBs
- Technically fully competent to perform all usual Senior Pharmacovigilance Scientist workload, including case report QC, review, follow-up and reportability assessments and input into aggregate safety reports, 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.
- Liaise with other relevant functional areas both within and outside of global PV to best ensure the most efficient and timely attainment of compliant and patient focused safety data.
- Represent pharmacovigilance department in cross-functional teams or committees and external environments at a global and regional level as required, with the advanced communication skills this requires.
- In depth knowledge and understanding of designated products/studies. If the responsible GSL, will be seen as the company's lead responder and source of expertise for safety related issues for designated compound.
- Expect close interaction and involvement with senior PV physicians and 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.
Ideal Candidates will have:
- Bachelor's degree required. Advanced degree or specific pharmacovigilance qualification preferred (MD, PhD, and PharmD)
- Excellent databases and coding skills including ability to perform advanced searches
- In depth 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
Does this sound like you would be that next amazing fit? Apply NOW!