Pharmacovigilance Database Specialist in Cambridge

The Scientific Team at Russell Tobin / Pride Health is hiring a Pharmacovigilance Specialist for a top pharmaceutical organization near Cambridge, MA.

Responsibilities:

• Triage, Intake, case entry and QC of ICSRs originating from Biogen sponsored studies or other assigned cases.
• Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders.
• Perform retrospective quality checks on processed cases.
• Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting.
• Review and resolution of reconciliation issues between the clinical and safety databases in collaboration with Data Management.
• Provide investigation details into late regulatory reporting of CT cases.

Requirements:

• Bachelor’s degree in science or healthcare related field.
• 4+ years experience in pharmacovigilance.
• Knowledge of Global and local safety regulations.
• Excellent written and verbal communication skills.
• Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva.
• Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance.
• Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
• Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required.

Additional Details:

• Onsite position.
• Position Type: contract position through the end of the year with potential for extension.
• Salary range approved: $50-60/hr depending on experience.
• Must be authorized to work in the United States.

Pride Global and its affiliates, including Russell Tobin, Pride Health, Pride Now, and Pride One, offers eligible employees comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.

Equal Employment Opportunity: Pride Global and its affiliates are an equal opportunity employer. We do not discriminate on the basis of race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.

Fair Chance Employment: Pride Global and its affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including the California Fair Chance Act and all applicable local Fair Chance ordinances.

Accommodations: We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.

Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.