Executive Director, Drug Safety & Pharmacovigilance
About the Company
Fast-growing biopharmaceutical company
Industry
Health, Wellness and Fitness
Type
Public Company
Founded
1993
Employees
501-1000
Categories
About the Role
The Company is seeking an Executive Director for Drug Safety and Pharmacovigilance. The successful candidate will be at the forefront of ensuring the safety and efficacy of the company's products, with a focus on those in clinical development and post-marketing surveillance. This key leadership role is responsible for developing and implementing strategies to achieve pharmacovigilance and medical safety goals, as well as representing the company in communications with health authorities. The role involves assessing safety signals, managing potential safety issues, and ensuring that all activities are in compliance with regulatory requirements and company standards. The Executive Director will also be involved in the development of risk management plans and will be accountable for the medical evaluation of safety data. Candidates for this role should have an MD degree or equivalent, with a strong background in pharmacovigilance, preferably in a pharmaceutical or biotechnology setting. Experience in signal management and a background in neurology, psychiatry, or CNS-related diseases are highly desirable. The ideal candidate will have a solid understanding of FDA and EU regulations, ICH guidelines, and a proven track record of at least 15 years in drug safety, including safety leadership experience. Advanced skills in assessing product risk-benefit profiles, strong attention to detail, and the ability to work independently are essential. The role also requires excellent interpersonal, communication, and organizational skills, as well as the ability to lead and train a team.
Hiring Manager Title
Head of Safety
Travel Percent
Less than 10%
Functions
...in loan repayment paid over three years (*Eligible flex full-time RN roles to receive prorated amount)\n Up to five and a half... ...dependents (plus discounts for UPMC employees including no cost RN-BSN/MSN options!\n \n The Professional Staff Nurse is a valued step...
...Job Description: GardaWorld Security Services is Now Hiring a Surveillance Security Officer! Site Location: Salt Lake City, UT Set schedule: Part time (12 hours per week), Saturday 7:00 am - 7:00 pm Competitive hourly wage of $18.00( Ready to suit up as a...
...Title: Academic Tutoring - Tutor I, Tutor II, Tutor III (Temporary Part-Time) Position Summary: Tutor students to improve their academic... ...persistent in helping students reach their goals. E. Writing/English tutors are required to have a minimum of a bachelor's...
...Job Title: Assistant Project Manager Company: Loenbro Mission Critical Location: Phoenix, AZ Pay: DOE Competitive Pay & Benefits Loenbro Mission Critical has strategically shifted its focus to specializing in data center and mission-critical electrical...
...beginning in the mid-1860s. Our long-standing expertise in printing continues to this day, as Susquehanna Printing produces the daily LNP newspaper and four local weekly newspapers, plus tabloids, books, and periodicals for businesses throughout the mid-Atlantic region....