Job Description

Summary of Key Responsibilities

• Works closely with the safety 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
• Responsible for evaluation and development of Safety Management Plans.
• Develop knowledge of capabilities and limitations of various data sources.
• ssist in the evaluation of potential safety issues and quality risk assessment reports.
• Contribute 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 of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
• Responsible for ensuring the global team can anticipate, develop and support improved/consistent scientific ways of working to implement effective Patient Safety and Risk Management processes.
• Contribute as a member of the Drug Safety team to scenario planning, strategy analysis, portfolio prioritisation, budget management and forecasting.
• Manage and support the 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 (MD, PharmD, RN) 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 :
Supporting the development and application of business process improvement methodologies and/or developing ideas into practical business solutions.
bility to manage teams and to work in a matrix environment in accordance with the company leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures.
Pharmacovigilance, safety or clinical science, and/or other relevant areas of clinical biopharmaceutical development or medical affairs.
Knowledge of Argus Safety Databases
Knowledge of Signaling tools (eg. Empirica)
dvanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
Strong planning, organization, written and oral communication skills
Experience in clinical patient care is a plus
Regulatory Inspection readiness experience is a plus

Special Skills : Ability to represent the functional department as primary internal and external contact on contracts and delivery for services relating to drug safety risk management. Lead cross-functional briefings and technical meetings for project stakeholders and customer representatives. Strong negotiation skills encouraging discussion and driving decisions to desired results. Strong analytic and scientific writing abilities.
Job Complexity : Involved in RMP and Aggregate Report Management. Managing through cross-functions, business partners and CROs. Responsible for the successful implementation and management of activities contributing to risk management.
Supervision: Individual is expected to work independently with support from management and colleagues in GPSRM.

• If employed in the U.S., being fully vaccinated aProductst COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required

Languages:
English( Speak , Read , Write )

City: Cambridge

Schedule:
Start Date: 08/08/2023
End Date: 02/09/2024
Schedule Notes: Potential to extend; Prefer onsite, but hybrid or remote ok
Hours Per Week: 40.00
Hours Per Day: 8.00
Days Per Week: 5.00

New Scientist