Manager, Pharmacovigilance
- Chennai
- Drug Safety
- ICON Full Service & Corporate Support
- Office Based
Talent Acquisition Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please see similar roles below...
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Roles & Responsibilities:
• Supports direct reports in monitoring of their projects to assure company profitability and associated project goals and objectives are being met.
• Develops, implements, and monitors profitability, objectives, metrics of assigned group of direct reports.
• Identifies and implements improvements of processes within the assigned service are through review of project specific plans and their implementation; recommends improvement plans to project.
• Manages resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual obligations.
• Analyzes current and future project backlog in order to provide adequate resources to meet business objectives.
• Builds and aligns a technical team to perform critical operating tasks to achieve results.
• Identifies and implements process improvements and other ways to improve efficiencies.
• Provides technical oversight of the generation of project plans such as but not limited to Safety Management plans (SMP), or SAE Reconciliation plans, in close cooperation with project team during set-up phase.
• Delivers training on department related topics as well as general company processes and systems to Pharmacovigilance staff.
• Liaises with other functional managers to ensure consistency of safety management approaches within the company.
• Maintains familiarity with current industry practices and regulatory requirements that affect services provided respective service area.
• Reviews Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant, Pharmacovigilance (Senior) Project Manager and Pharmacovigilance Project Lead, Pharmacovigilance Assistants, group-related project tasks; provides leadership in the delivery of related services to clients.
• Ensures that staff fulfill their responsibilities in accordance with company and/or client QMS, policies, procedures, and SOPs, as applicable.
• Creates an environment that encourages learning, self-improvement and career development for staff.
• Supports the development and implementation of training for Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant, Pharmacovigilance (Senior) Project Manager and Pharmacovigilance Project Lead, Pharmacovigilance Assistants, or other personnel within the assigned service area.
• Recommends and supports implementation of performance and productivity improvements within the assigned service area to ensure optimal utilization of billable staff.
• Performs metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes.
• Identifies and implements process improvements through review of SOPs, processes; recommend improvement plans to senior management.
• Participates in task forces to implement process improvement initiatives.
• Builds teamwork and improves process and productivity by working within and across functional areas.
• Develops company employees to ensure high quality work performance and retention of high quality employees.
• Ensures staff development and performance feedback are provided through activities such as mentorship and career development.
• Communicates team/individual goals and expectations to ensure direct reports understand their responsibilities.
• Involved in the recruiting processes for new employees in the assigned service area.
• Assists with bringing new business opportunities to the company and maintaining existing clients’ relationships for repeat business.
• Interacts with clients and participates in client meetings as necessary to support and maintain new business.
• As assigned, participates in business development initiatives, including presentations and proposal development.
• Ensures that timely and accurate information is submitted on all proposal efforts.
• Participates in business development initiatives, including presentations and proposal development.
• Supports direct reports and senior management during audit preparation and conduct. Responds to audit findings as needed.
• Prepares Standard Response letters, including conducting literature search, article summary etc.
• Responsible for vendor management (e.g. LPPharmacovigilance)
• Supports Qualified Person for Pharmacovigilance as required
• Travel (approximately 15%) domestic and/or international
• Management of assigned safety and/or medical information call center handling teams to ensure project and departmental deliverables are being met.
• May serve as Local/Qualified Person for Pharmacovigilance (including deputy level)
Supervision Given
• Works under general supervision and coaching for managerial task;
• Works independently most of the time.
Criteria:
Should have 8-10 years of work experience in Clinical Research & in safety background with 2 years in People Management.
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
Teaser label
Inside ICONContent type
BlogsPublish date
09/29/2022
Summary
A Drug Safety Associate is responsible for assessing the safety of pharmaceuticals drugs once they’re on the market. Using standardised guidelines, they determine whether the medication causes any adv
Similar jobs at ICON
Salary
Location
India, Chennai
Location
Chennai
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug Safety
Job Type
Permanent
Description
Job Description• Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, i
Reference
JR125423
Expiry date
01/01/0001
Author
Archana BakkiyarajanAuthor
Archana BakkiyarajanSalary
Location
Brazil, Sao Paulo
Location
Sao Paulo
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug Safety
Job Type
Permanent
Description
We are currently seeking a Pharmacovigilance Associate & Senior Associates to join our diverse and dynamic team.Location:- Sao Paolo, Brazil (Hybrid mode: 3 days at office, 2 days from home)Responsibi
Reference
JR126548
Expiry date
01/01/0001
Author
Florencia PistolesiAuthor
Florencia PistolesiSalary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug Safety
Job Type
Permanent
Description
We are currently seeking a Senior Pharmacovigilance Associate to join our diverse and dynamic team.Location:- Mexico City, Mexico (Hybrid mode: 3 days at office, 2 days from home)Responsibilities:• Re
Reference
JR125090
Expiry date
01/01/0001
Author
Florencia PistolesiAuthor
Florencia PistolesiSalary
Location
China, Shanghai
Location
Shanghai
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug Safety
Job Type
Permanent
Description
We are currently seeking a Pharmacovigilance Reporting Associate to join our diverse and dynamic team. As a Pharmacovigilance Reporting Associate at ICON, you will be responsible for the accurate and
Reference
JR126413
Expiry date
01/01/0001
Author
Jessica ZhongAuthor
Jessica ZhongSalary
Location
India, Chennai
Location
Chennai
Trivandrum
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug Safety
Job Type
Permanent
Description
• Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, t
Reference
JR124495
Expiry date
01/01/0001
Author
Archana BakkiyarajanAuthor
Archana BakkiyarajanSalary
Location
Mexico, Mexico City
Location
Sao Paulo
Mexico City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug Safety
Job Type
Permanent
Description
We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team. As a Pharmacovigilance Associate at ICON, you will play a vital role in monitoring and ensuring the safety
Reference
JR126444
Expiry date
01/01/0001
Author
Elizabeth DaviesAuthor
Elizabeth Davies