The Director will lead the ongoing signal detection monitoring, product risk-benefit assessment, and safety assessment activities of designated drugs and/or indications. The Director will work closely with the Medical Safety & Pharmacovigilance team and in addition will be a key member in one or more cross-functional clinical development and will report to Sr. VP of Drug Safety and Pharmacovigilance.
This position accepts considerable responsibility for the medical safety management of drugs in clinical development and in the post-marketing (preferred but not required) setting. The Director must possess strong analytical team player skills.
- Reviews all appropriate safety data from various sources throughout the product development lifecycle.
- Conducts medical assessment of all safety related data (AEs, SAE, SUSAR, AESI etc.).
- Ensures medical accuracy of case narratives, coding and medical sense of all cases and ensures appropriate queries are raised for a comprehensive medical review
- Participates in investigators' meetings to provide training on adverse events reporting as required.
- Authors/reviews relevant sections of all aggregate safety reports and ensures the overall quality of documents.
- Authors, reviews and provides input for drug-safety related regulatory reports and clinical study documents including Clinical Study Protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product package labeling, Company Core Safety Information (CCSI)
- Responsible for responses to queries from regulatory authorities or health care professionals on safety issues and any legal queries and requests involving safety issues.
- Familiar with MedDRA, WHODRL and safety databases such as ARGUS.
- Ensure ongoing safety monitoring of investigational and marketed products to include detection of signal and assessment of risk, assessment of the risk-benefit balance of products and analysis of the overall safety of products.
- Assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety.
- Provides oversight over the monitoring of clinical trial safety and monitors site compliance with protocol-specified measures intended to ensure the safety of subjects.
- Contributes to regulatory filings (including NDAs/MAAs) and responses as needed
- Contribute to the creation and maintenance of Reference Safety Information, and the safety sections of Investigator Brochures for all investigational products
- Participate in in inspection readiness activities and preparation as needed
- Stay current with international pharmacovigilance requirements and guidelines (focus on FDA and EMA)
- Health care professional degree required (RN, BSN, PA, NP, PharmD or MD)
- Minimum 5-8 years for experience in pharmaceutical safety, preferred work experience in metabolic and hepatic disease
- Strong skills in the management of safety information originating from both clinical development and post-marketing sources
- Ability to take initiative yet work collaboratively on multiple projects and with partner companies to achieve goals in compliance with PV and regulatory requirements and safety data exchange agreements
- Demonstrated competence in obtaining, analyzing, disseminating and reporting safety information in compliance with global regulations.
- Demonstrated experience in managing business processes outsourcing vendors and relationships
- Strong team player in a multifunctional, multicultural, growing organization.
- Ability to operate objectively and independently as a leader and as a member of a team, as required.
- Ability to interpret and apply applicable regulations to resolve issues and ability to develop business solutions to complex problems.
- Strong organizational, project management, technical and problem-solving skills.
- Well-developed presentation, communication and interpersonal skills, including strong oral and written communication skills.
- Experience and extensive working knowledge of MedDRA, Clinical Database (eg: RAVE), safety databases (i.e.: ARISg, ARGUS), Microsoft Office suite (Word, Excel, PowerPoint)