Title: PV Scientist Manager
Location: Cambridge or Virtual
Time Zone: EST or CST
Work Arrangement: Onsite or Remote
Contract: 6 Months
Schedule: Full-time, normal business hours
Pay: $100/hr- $110/hr on w2
Summary of Key Responsibilities:

• Works closely with the safety lead physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
• Contribute to signaling and data mining activities utilizing internal and external sources of data. Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
• Assists in evaluation and development of Safety Management Plans
• Assists in data analysis compilation and presentation at cross-functional meetings.
• Assists in the evaluation of potential safety issues.
• Contributes to activities related to the functioning of Client safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues.
• Contributes to the development and management of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
• Assists in RMP and DRMP development and updates.
• Supports authoring for aggregate safety reports (eg.PSUR, DSUR, Line listings) in close collaboration with the safety product lead and operational functions

Qualifications:
Education : Degree in a medical or healthcare related discipline (PharmD, RN, MD) is required
Experience : A minimum of five to seven years in the pharmaceutical industry with experience in drug safety/pharmacovigilance. Previous experience in managing drug safety personnel a plus. Specific experience in RNA therapeutic area at a global level is an advantage.
Strong skills and experience in :

• Ability to work in a matrix environment in accordance with the company leadership commitments and values.
• Excellent planning, organization, written and oral communication skills
• Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
• Understanding Signaling tools (eg. Empirica)
• Experience in clinical patient care is a plus
• Regulatory Inspection readiness experience is a plus

Supervision: Individual is expected to work independently with support from management and colleagues in SRM.