Title: Medical Safety Scientist
Location: Fully Remote (East Coast +/- 1-2 hours)
Hourly Rate: Competitive
Contract Type: 12-month Contract
BioTalent is delighted to be partnered with a leading Pharmaceutical Manufacturing company and we are on the hunt for a Medical Safety Scientist to join the team on a long term contract basis.
You Will:
- Manages and trains junior safety scientists in respective TA
- Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program.
- Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns.
- Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness
- Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation.
- Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required.
- Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate.
- Authors or provides guidance for the production of risk management plans (RMPs).
- Provides strategic input into regulatory requests / responses.
- Delivers clinical safety input into clinical development program.
- Leads the medical safety contributions of global regulatory submissions for new products, formulations, or indications.
- Participate in and/or lead internal safety surveillance meetings as well as joint safety meetings with licensing Partners, as needed.
- Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements.
Requirements:
- At least 8 years of experience in drug safety, including at least 5 years of experience in surveillance / risk management.
- Ability to independently search clinical safety and literature databases for relevant information.
- Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management.
- Excellent medical writing skills, as well as proven ability to effectively lead interdisciplinary teams.
- In-depth knowledge of medical and drug terminology, as well as the clinical development process.
- Familiarity with MedDRA and safety databases; Proficient with Windows applications, and ability to learn new programs / databases.
Required/Preferred Education:
- Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline and experience.