Contractor, PV Scientist

Job Description

Job Description

The Contractor, Pharmacovigilance Scientist supports safety data analyses for investigational and / or marketed products in partnership with the Pharmacovigilance Sciences team and product Safety Physician. The Pharmacovigilance Scientist is expected to be equally effective in working collaboratively and independently. She / he will support activities such as signal management, aggregate safety reports, RMP development, ad hoc safety query responses, literature surveillance, and safety analyses for regulatory submissions or clinical trial documents, as applicable. The Pharmacovigilance Scientist also supports process improvement initiatives, including updates to SOPs, WIs, and other documents.

Key Responsibilities :

• Support signal management activities, as needed, in collaboration with the Pharmacovigilance Scientist team product Safety Physician.
• Support aggregate safety reports (e.g. DSURs, PADERs, PBRERs), including data analysis, report authoring, and quality checks.
• Support RMP updates and REMS reports as appropriate.
• Support ad hoc query responses and safety analyses for regulatory submissions or clinical trial documents, as needed.
• Support literature surveillance for marketed products and medicinal products under development, as applicable.
• Demonstrate knowledge and remain up to date to ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.).
• Contribute to process improvement initiatives and consistency of cross-product processes.
• Maintain inspection readiness.
• Perform other tasks as assigned or required.

Qualifications :

Company Description

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser : https : / / jobs.beaconhillstaffing.com / eeoc /

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Company Description

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply. If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser : https : / / jobs.beaconhillstaffing.com / eeoc / Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.