Associate Director Pharmacovigilance
Proclinical is currently recruiting for a PV Physician for a pharmaceutical company located in Princeton, NJ. Successful candidate will provide strategic and proactive safety input into development plans; provide scientific input/review of clinical study protocols, clinical study reports, Investigator Brochures, and case report forms for bioequivalence, bioavailability and safety/efficacy studies.
- Ensure that all pharmacovigilance obligations are fulfilled and that all the required PV activities are in line to support an assigned clinical trial and to ensure subject safety.
- Maintain pharmacovigilance expertise, and understanding of international safety regulations and guidelines, and global HA/ethics expedited and periodic submission requirements.
- Provide medical guidance to assigned projects and other departments on clinical expertise matters.
- Address labeling concerns and updates.
- Oversee clinical assessment of adverse events, SAEs, SUSARs and safety signals collected from clinical trials, and post-marketing surveillance in the assigned therapeutic area(s). Overall responsibility for assessing expectedness and company causality in a timely manner.
- Risk Assessment/Risk Management/Benefit-Risk Analysis: Provide proactive risk assessment and develop risk management strategies.
- Submission Activities: Represent safety position in cross functional submission teams. Ensure generation, consistency, and quality of safety sections in submission documents. Author responses to health authorities' questions and support preparation of Advisory Committee meetings.
- Signal Detection and Assessment: Responsible for signal detection and evaluation. Identify and implement proactive safety analysis strategies to further define the safety profile.
- Lead aggregate safety data review activities and coordinate safety surveillance activities.
- Medical follow-up of clinical trial cases with the investigators for missing/clarification of safety information in a timely manner.
- Prepare or review Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans in liaison with clinical development teams and CROs.
- Support due diligence activities and pharmacovigilance agreements.
Skills and Requirements:
- MD is preferred.
- 3+ years' clinical research experience.
- Drug safety experience in a global pharmaceutical or global CRO is preferred.
- Must possess a strong clinical and scientific background. Must be familiar with electronic safety databases and coding dictionaries. Must possess knowledge of international pharmacovigilance regulations and drug development processes.
- Able to develop and document sound risk assessment.
- Able to work collaboratively within the Global Clinical Development organization (including Clinical, Statistics, Regulatory, and Operations groups).
- Demonstrates leadership within cross-functional team environment for safety related issues.
- Good communication skills (verbal and written).
- Ability to solve problems with a variety of complex variables through non-standardized solutions that require independent judgement and analysis.
- Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
- Must possess computer skills by using MS Word, Excel, and Microsoft Outlook.
- Ability to read and interpret comprehensive and intricate research documents.
- Proficiency in speaking, comprehending, reading and writing in English is required. Fluency in Chinese desirable.
- Ability to undertake periodic domestic and infrequent international travel (to sites or to Investigator or CRO meetings).
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 at (+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.