Medical Safety Specialist
3 weeks ago
Job 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 seeking a Medical Safety Scientist to join the team on a long-term contract basis.
Key Responsibilities:
- Manage and train junior safety scientists in respective therapeutic areas
- Lead cross-functional safety management teams and drive safety strategy for responsible products/programs
- Drive signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns
- Ensure that processes and procedures are up to date to meet regulatory requirements and inspection readiness
- Effectively communicate with members of the interdisciplinary team regarding ongoing signal evaluation
- Ensure that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates
- Produce accurate and fit-for-purpose evaluation documents with clear conclusions, as required
- Lead the coordination of aggregate safety reports and authors relevant sections, as appropriate
- Author or provide guidance for the production of risk management plans
- Provide strategic input into regulatory requests/responses
- Deliver clinical safety input into clinical development programs
- Lead 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
- Provide 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
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