The incumbent will be responsible for drug safety, Risk management and ensure the compliance of regulatory requirements with high medical and scientific quality and standards.
Incumbent provides the medical guidance / decisions for Drug Safety operations.
Incumbent will also be responsible for setting up services for aggregate reporting, signal detections and risk management and other area.
This role is a critical part and will play a major role in the development organization, and ultimately responsible, for the pharmacovigilance services for all clients
Client Engagement :
The General manager for PV Services is responsible for risk, revenue, profitability, growth and customer satisfaction of their portfolio.
Monitors the entire lifecycle of client engagements, from initial scoping and contracting through close of the engagement with the customer.
Resource Management :
As a leader of people and teams, the general manager, PV Services makes decisions to build teams, develop their skills and improve the overall efficiency and productivity of teams.
Manages the Safety Case processing, Aggregate reporting, Literature Search, Signal detection and other teams and ensures appropriate information is processed and reported according to ICH-GCP / FDA guidelines, regulatory requirements, and SOPs and procedures.
Keeps up-to-date on all regulatory guidelines and mentors the PV teams
Manages, directs and provides strategic leadership to the development, implementation, and continuous improvement of an effective quality assurance program designed to meet Corporate, government and internal standards.
Manage day-to-day client interaction.
Strong project management skills with a keen desire for continual improvement
Meet and exceed Revenue targets for the departments.
Ensure proper project execution and minimizes risk on projects
All other responsibilities as assigned
Experience in Pharmacovigilance process.
Experience in Drug Safety Applications and Regulatory compliance applications would be ideal.
Knowledge of 21 CFR Part 11 guidelines, Volume 9A, Computer system validation guidelines
Experience in Service Delivery of Large sized projects
Excellent relationship management skills
Strong project management skills, with a keen desire for execution
Strong analytical and strategic thinking abilities
Education : MBBS / MD with Experience in Life Sciences Industry / Master’s Degree and / or MBA Would Be an Advantage; Master’s degree is mandatory for candidates with bachelor’s degree in Health Care (BPharm / BDS / BHMS / BAMS).
Experience : Minimum 10 years of experience & over 7 years of experience in Pharmacovigilance
Strong motivational skills and abilities, promoting a team-based approach
Strong interpersonal and communication skills, both verbal and written
Strong organizational and leadership skills
Ability to maintain professional and positive attitude
Travel : 0-50% (can be adjusted)
Lifting : 0-50 lbs. (can be adjusted)
Other : Computer work for long periods of time
THIS JOB DESCRIPTION SHOULD NOT BE DEEMED ALL-INCLUSIVE.ADDITIONAL REQUIREMENTS AND EXPECTATIONS MAY BE ASSIGNED.AT ALL TIMES, EMPLOYEES ARE EXPECTED TO ADHERE TO COMPANY POLICIES AND COMPANY SOPS.
Bioclinica is an equal opportunity employer.Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability / handicap status, or any other legally protected characteristic.
Collaboration, Continuous Learning, Critical Thinking, Operational Excellence, Organizational Awareness, Results Orientation, Service Orientation, Team Development