Pharmacovigilance Scientist

Proclinical is seeking a Pharmacovigilance Scientist for a leading pharmaceutical company located in Boston, MA.

Must be eligible to work in the US.

Job 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.
• Assist in the evaluation of potential safety issues and quality risk assessment reports.
• Contribute to activities related to the functioning of 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 prioritization, 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
• 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 against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required

Skills and Requirements:

• Supporting the development and application of business process improvement methodologies and/or developing ideas into practical business solutions.
• Ability 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) Advanced 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.
• Degree in a medical or healthcare related discipline (MD, PharmD, MSN RN) is required
• 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.

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at +(1) 617-830-1769 or b.forsen@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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