Director, Drug Safety & Risk Strategy

Alnylam Pharmaceuticals; Philadelphia (Philadelphia County); On-site; USD 220,000 - 320,000; Full time

Benefits offered by this job

Medical insurance

Dental & vision coverage

401(k) match

Paid time off

Job summary

Alnylam Pharmaceuticals is seeking a Director of Medical Safety and Risk Management to lead the safety profile for its product portfolio across the lifecycle. You will partner with clinical, regulatory and commercial teams and provide strategic safety input to regulatory agencies.

The role requires medical degree, clinical pharmacovigilance experience and strong analytical, written and interpersonal skills to drive safety across global programs and regulatory submissions.

Qualifications

• Medical Degree with a minimum of 3 years of medical practice is required.
• Sound clinical acumen and a wide range of therapeutic area knowledge.
• Pharmaceutical industry experience in pharmacovigilance and/or clinical research/development is preferred
• Experience in clinical development is a plus.
• Knowledge of clinical research methodology, clinical epidemiology/biostatistics, pharmacovigilance tools and processes and relevant regulatory framework.
• Ability to synthesize and analyze safety data from various sources. Proficiency in problem-solving within a highly complex environment.
• Strong communications skills, both written and spoken, ideally with demonstrable experience in medical / scientific writing.
• Excellent networking and relationship building skills for successful cooperation with internal and external customers.
• Expertise in international regulations governing drug safety. Experience in managing compliance or audits. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments highly preferred.
• Excellent interpersonal and decision-making skills. Strong influencing skills with the ability to quickly earn credibility across other functional areas.
• Ability to work in fast-paced environment with rapidly approaching timelines is important

Responsibilities

• Lead strategic development of the safety profile of assigned products.
• Lead active monitoring and continued assessment of safety data through signal detection and literature review across all lifecycle phases.
• Guide clinical development teams on safety endpoints, analysis and interpretation of safety data.
• Ensure timely completion of safety deliverables for CSRs, regulatory submissions and other documents.
• Lead Safety Risk Management Teams on safety topics and propose solutions based on data.
• Provide safety expertise to internal stakeholders and regulatory agencies; align on safety strategy for products.
• Author safety documents and communications (DSUR, SAMP, PSUR, RMPs) and related regulatory responses.
• Collaborate with pharmacovigilance and external partners to harmonize safety issue identification and communication

Skills

Medical judgment

Analytical thinking

Communication skills

Networking

Influencing skills

Stakeholder management

Cross-functional collaboration

Problem solving

Interpersonal skills

Education

Medical Degree

Job description

Alnylam Pharmaceuticals is seeking a Director of Medical Safety and Risk Management to lead the safety profile for its product portfolio across the lifecycle. You will partner with clinical, regulatory and commercial teams and provide strategic safety input to regulatory agencies.

The role requires medical degree, clinical pharmacovigilance experience and strong analytical, written and interpersonal skills to drive safety across global programs and regulatory submissions.