Proclinical is currently recruiting for a PV Physician with a global pharmaceutical company located in Princeton, NJ. As the PV Physician, you will function as the safety expert for products the company is developing or commercializing.
- 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.
- 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. Provide support for planned NDAs including drafting and editing of modules and labels for submission.
- Address labelling 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.
- Maintaining the safety profile of the company's products in development in collaboration with clinical leads.
- Risk Assessment/Risk Management/Benefit-Risk Analysis: Provide proactive risk assessment and develop risk management strategies.
- 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 Degree is preferred.
- 3+ years of 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 undertake periodic domestic and infrequent international travel (to sites or to Investigator or CRO meetings).
If you are having difficulty in applying or if you have any questions, please contact Nicole Aganon at (+1) 347-293-1161 or email@example.com
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.