Associate Medical Director
Proclinical is currently recruiting for an Associate Medical Director of Drug Safety and Pharmacovigilance for a biopharmaceutical company located in Cambridge, MA. Successful candidate will be responsible for the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information.
- Provide medical expertise in the assessment of ICSRs and aggregate drug safety reports
- Review, analyze, and compile safety data, and present the results
- Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports
- Support of the internal PV Operations function
- Contribute to ongoing safety surveillance and signal detection efforts
- Contribute to signaling and safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signals
- Serve as a medical resource for the generation and review of clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs)
- Provide medical safety input into the development of Reference Safety Information
- Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documents
- Provide medical safety and Pharmacovigilance expertise in-house and by consultation with outside vendors for all development programs
- Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents
- Contribute to safety and pharmacovigilance training programs
- Provide safety training at investigator meetings
- Present safety data and results
- Collaborate with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community
- Collaborate with Medical Directors and Clinical Research Scientists, and vendor clinical staff who provide medical monitoring support for ongoing clinical trials
- Develop relationships with and capture drug safety information from key groups, including partner companies, physicians, nurses and patient advocacy groups
- Serve as a subject matter expert for vendors providing drug safety and pharmacovigilance services
Skills and Requirements:
- 2+ years' experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
- Medical Degree (MD) from recognized medical school with medical practice experience
- Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
- Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities
- Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.
- Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment)
- Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER)
- Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval
- Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels
- Experience with MedDRA coding, Points to Consider, AoSE, and SMQs
- Excellent verbal, written and presentation skills
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brendan Dunn at (+1) 646-481-1930 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.