Apple & Associates, Inc.
1 - $1
Two MD contractors needed for Global Pharmaceutical company in Cambridge, MA
two roles-Contract Role Only
One year contract (renewal up to 4 years), w-2 with benefits offered
Has to be office based in Cambridge- we will only consider local candidates at this time.
We need PV experience within submissions specifically
We have a submission approaching for a product. Need someone with good clinical trial experience. Worked in clinical trial as opposed to post trial setting
SPA or European Medicine Agency
Must have worked in Global Setting.
Must have worked in Global Pharma Setting.
They working on regulatory submission documents
Position Title: Medical Director, Pharmacovigilance
Function: Research and Development
1 Year Assignment
• Support developmental programs, including both early and late stage development as required.
• Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibly as appropriate.
• Supporting Therapeutic Lead
• Line management responsibilities for junior physicians and/or scientists
• Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs
• Expectation of GSL role for compound(s) both in development and marketed in close association with the TAL.
• Company wide safety expert for his/her compound responsibilities
• Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for ‘own’ compounds with input for other compounds as needed.
• Serving in a leadership capacity for complex and strategically important programs
• Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc
• Training and mentoring of Pharmacovigilance Physicians and Specialists
• Perform activities required to serve as Global PV physician:
- Review and oversight of safety data, both non-clinical and clinical
- Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
- Interactions with external experts and regulatory agencies and partner/co-development companies
- Review of safety data and participate in dose escalation decisions
- Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
- Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
- Direct the set up of safety procedures and development of safety exchange agreements for co-development projects
• Maintain professional knowledge and accreditation by active participation in continuing medical education activities
SCOPE OF SUPERVISION:
NUMBER SUPERVISED WORKERS Direct In-Direct
Employees 0 0
Non-Employees 0 0
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
• Qualified physician (Licence, e.g. GMC registered, preferred)
• Knowledge of principles of epidemiology and statistics.
• Critical thinking and analytical skills and ability to make high level decisions
• Excellent oral and written communication skills including ability to present to large internal/external groups
• Good level of computer literacy with Microsoft applications
• Routine demands of an office based environment.
• Estimated 5-10 times per year including international travel
ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY):
• Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development
• 2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
At Apple & Associates, we understand that relationships are what make us stand apart. Whether you are a client or a candidate, you are an extension of the Apple & Associates’ family. Many of our recruiters have been with the company since its earliest days. They take great pride in the relationships they build; always emphasizing high standards, ethics and quality service. Our President, Debi Apple started her recruiting career in Aiken, South Carolina. She quickly became a top producer and leading authority in recruiting for the medical device, pharmaceutical and consumer product industries. Her passion and drive led her to open Apple & Associates in 1993. Under her leadership, Apple & Associates has grown to be one of the leading recruiting firms in these industries. Our company is proud to represent two of the largest medical device and pharmaceutical companies in the U.S., Covidien (formerly known as Tyco Healthcare) and our first and longtime client, Becton Dickinson. Now headquartered in Chapin, South Carolina, Apple & Associates has offices from coast to coast, offering regional recruiting expertise throughout the U.S. and Latin America. Our searches and permanent placements represent all levels, from CEO to staff level positions.