Sr Medical Director, Drug Safety
Proclinical is currently recruiting for a Senior Medical Director of Drug Safety with a leading biopharmaceutical company located in San Carlos, CA. As the Senior Medical Director, you will provide medical expertise within the Drug Safety department throughout the life-cycle of products in development and post-marketing.
Skills and Responsibilities:
- Review all appropriate safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the product development life-cycle to proactively identify any new safety issues that may require further evaluation to determine a causal relationship with products in development or on the market.
- Conduct medical review and assessment of clinical trial and post-marketing cases for all products, ensuring the case narratives are medically accurate, the events within cases are properly coded and have the proper labeling assessment, and that cases are queried for additional information as needed.
- Author the analysis of similar events (AOSE) for any expedited cases.
- Author or provide medical review of all aggregate safety reports such as Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Investigational New Drug (IND) Annual reports, and line listings of Suspected Unexpected Serious Adverse Reactions (SUSARs) for regulatory submission.
- Author or contribute to safety sections of regulatory submissions, including New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and responses to regulatory authorities.
- Provide product safety training to internal employees and external contractors / vendors as needed.
- Participate in investigators' meetings to provide training on adverse events reporting as required.
- May prepare and present product safety issues at internal and external meetings.
- Assist in the creation, review and implementation of new Standard Operating Procedures (SOPs), Work Instructions, guidelines, documents and other tools pertaining to the role.
Skills and Requirements:
- Doctoral-level degree in medicine or equivalent combination of education and experience. Clinical experience in the practice of medicine.
- At least 5 years of experience in pharmacovigilance organizations is preferred.
- Knowledge of pre- and post-marketing US and Global regulations for pharmacovigilance, including the Code of Federal Regulations, the European Union Good Pharmacovigilance Practices modules, and the International Council for Harmonization (ICH) guidelines and principles.
- Familiar with Medical Coding (eg, MedDRA, WHO-Drug).
- Proficient with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and safety databases (eg, ARISg, ARGUS, etc.).
- Excellent verbal and written communication skills (proficient in English).
- Ability to multitask under tight deadlines while providing attention to detail and high quality work in a fast-paced and dynamic environment.
- Ability to be flexible, adapt to change, and work independently or as part of a multi-disciplinary team
- Experience working in a matrix environment
- Ability to be customer-focused and have a disciplined approach to work.
If you are having difficulty in applying or if you have any questions, please contact Nicole Aganon at (+1) 646-779-7968 or firstname.lastname@example.org.
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.