Medical Director - Global Safety Lead - Pharmacovigilance
Proclinical is currently recruiting for a Medical Director of Global Safety Lead for a pharmaceutical company located in Bridgewater, NJ. Successful candidate will function as the Global Safety Leader (GSL) for an assigned portfolio of products in development and marketed products.
- Oversee ongoing safety of Phase 3 studies as lead CS physician and serve as the Clinical Safety PV (CSPV) functional representative at Global multifunctional project team meetings.
- Prepare, summarize, and review aggregate safety analyses. Additionally, develop and implement integrated project/product risk management strategies and drafts the Risk Management Plan with Level III.
- Work with other CSPV staff and SMT members and serves as the CSPV representative on TR-PT/IPT on Phase 1 and 2a products.
- Medical safety review of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the product life cycle for assigned products.
- Conduct signalling activities, including monitoring, evaluation, interpretation, management and communication of safety information.
- Lead the Product Safety Teams for assigned products and manage benefit-risk profiles along with the related actions, including write and update the benefit-risk documents for assigned products and development compounds.
- Medical expert safety review of and input into all critical documents for assigned products in clinical development.
- Collaborate with the Head of Safety to develop and implement the strategy for benefit-risk management for assigned products.
- Author important medical content of Risk Management documents (e.g., RMPs, REMS)
- Write periodic reports for assigned products and providing medical interpretation, review and approval for required reports where applicable.
- Provide expert safety input into clinical development programs for assigned products
- Provide the medical safety content for responses to inquiries from regulatory authorities related to safety topics and integrated safety input into any applicable regulatory documents where required.
Skills and Requirements:
- Health care professional with MD, DO or equivalent.
- 8-12+ years clinical/practical experience in a relevant clinical environment. 2+ years of Pharmacovigilance experience in Clinical Safety or Post-Marketing Safety including thorough knowledge of FDA and ICH safety reporting regulations and guidelines. Any experience with regional, national and global regulatory authority is a plus.
- Strong oral and written communication skills
- Advanced analytical skills
- Sound medical judgment and decision-making capabilities
- Strategic thinking and facilitative leadership
- Fluent utility of office computer programs such as Excel, Word, and PowerPoint
- Sound organizational and prioritization skills
- Formal training in Epidemiology a plus
- Demonstrated skills for project management
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 Yannick Dada (+1) 646-741-8433 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.