Sr. Principal PV Scientist (Oncology & Rare Disease)
Greater Boston Area
A highly successful global biopharma organization is seeking two Sr. Principal PV Scientists to join their rapidly expanding team! One opening will sit on the Oncology team while the other will sit on the Rare Disease 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 Sr. Principal PV Scientist will be responsible for:
- 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.
- Mentorship and guidance for less experienced colleagues within the department.
- Conduct project activities for designated developmental products.
- Lead set up of safety procedures for complex developmental programs.
- Contribute to development of 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
Ideal Candidates will have:
- D., or foreign equivalent, PhD, or Bachelor's degree with significant industry experience.
- Minimum 3 pharmacovigilance experience in safety science related tasks.
