- Manages multiple aspects of projects, both local and globally, such as contractual, procedural and regulatory requirements.
- Maintains good communications with other functional groups concerning program and company issues. Collaborates with other employees in problem solving and systems improvement.
- Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
- Maintains a basic medical understanding of applicable therapeutic area and disease states. May participate on-call duties for specific projects and ensures 24-hr coverage for intake of cases from investigative sites.
- Provides plans and accurate forecasts for all projects.
- Serves as a resource to other departmental managers and leads departmental initiatives.
- Prepares and presents proposals.
- Manages staff of experienced professionals, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification to include 3+ years of safety experience
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- 1+ year of leadership responsibility
- Working knowledge of the global regulatory requirements and the importance of and compliance with procedural documents
- Strong knowledge of relevant therapeutic areas as required for processing AEs
- General knowledge of pathophysiology and the disease process
- Time management and project management skills
- Proficient in Microsoft Office products and safety databases
- Good command of English and ability to translate information into local language where required
- Excellent oral and written communication skills
- Strong attention to detail and accuracy
- Strong critical thinking, problem solving and decision making skills
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel. (Recruiter will provide more details.)
-
Cs Writing Scientist
3 days ago
Haleon Hyderabad, India**Job Description**: · **Site Name**: India - Andra Pradesh - Hyderabad · **Posted Date**: Jan · Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovati ...
-
Associate, Pharmacovigilance
2 hours ago
Bristol-Myers Squibb Hyderabad, Telangana, India**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
-
Clinical Safety Contractor
4 days ago
NITZ Consulting Private limited Hyderabad, India Freelance**NITZ Consulting private Limited Inc. ("NItz") **is committed to providing quality service in the field of pharmacovigilance to clients. Our clients range from mid-size to small pharmaceutical companies located worldwide who are engaged in developing a proprietary pipeline of no ...
-
Vigilance Quality Excellence Expert
1 week ago
Novartis Hyderabad, Telangana, India100+ process improvement initiatives in Operational Excellence We are continuously improving pharmacovigilance processes and deliverables across Chief Medical Office and Patient Safety, ensuring adherence to Novartis Policies and compliance with international regulations, support ...
-
Pv Capability
2 days ago
Novartis Hyderabad, India"2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength Those joining Sandoz in the coming months will help shape the future of the company, it's growth, innovatio ...
-
Business Excellence Officer
4 days ago
Axios International Hyderabad, Telangana, IndiaJob Location - Delhi/Mumbai/Bangalore OR Hyderabad · **Position Purpose** · The purpose of the job is to manage access program(s) in the region. The jobholder is required to help represent Axios in daily meetings with patients and doctors and carry out administrative duties which ...
-
Regulatory System Associate
2 days ago
Haleon Hyderabad, Telangana, IndiaThe purpose of this role is to manage the regulatory information management (RIM) system for all Consumer Healthcare products worldwide to support key regulatory processes and enable the company to meet its regulatory, legal and pharmacovigilance obligations. This role is respons ...
-
Dir. Ddit Gdd Ps&pv Delivery Excellence
4 days ago
Novartis Hyderabad, Telangana, India20 years and 2 million-years of patient data waiting for you to unlock the next breakthrough in medicine. · Be accountable for the effective delivery of technology solutions by all required DDIT functions for a business area. Support innovation initiatives, DDIT strategy and the ...
-
Regulatory System Associate
3 days ago
Haleon Hyderabad, Telangana, IndiaJob Purpose: · The purpose of this role is to manage the regulatory information management (RIM) system for all Consumer Healthcare products worldwide to support key regulatory processes and enable the company to meet its regulatory, legal and pharmacovigilance obligations. This ...
-
Sanofi US Hyderabad, Telangana, India**Job title**: _Expert - Product Complaints, Hyderabad Hub, Business Operations_ · **Hiring Manager**:_ Head - Quality Services, Hyderabad Hub, Business Operations_ · **Location**:_ Hyderabad, India_ · **% of travel expected**:_ Travel required as per business need _ · **Job type ...
-
Associate Director, External Affairs
21 hours ago
Bristol Myers Squibb Hyderabad, India Full timeDescription · The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety ...
-
Safety Specialist
2 weeks ago
Thermo Fisher Scientific Hyderabad, India Full timeJob Description · Job Description · Performs day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, re ...
-
PV Information Specialist GPIO
1 week ago
Parexel Hyderabad, India Full timeWhen our values align, there's no limit to what we can achieve. · The Pharmacovigilance Information Specialist (PVIS) for GPIO (Global Pharmacovigilance Information Office) will research, review, and maintain information related to expedited and periodic safety reporting require ...
-
Specialist, Learning Media and Communication
5 days ago
Bristol Myers Squibb Hyderabad, India Full timeDescription · WWPS is responsible for ensuring the safety of our medicines: pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and str ...
-
Safety Reporting Admin
1 week ago
Thermo Fisher Scientific Hyderabad, India OTHERJob Description · At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with th ...
-
Specialist, Learning Media and Communication
1 week ago
Bristol Myers Squibb Hyderabad, India Full timeDescription · WWPS is responsible for ensuring the safety of our medicines: pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and str ...
-
Global Risk Management Scientist
1 week ago
Bristol Myers Squibb Hyderabad, India OTHERWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Specialist, Learning Management Support
1 week ago
Bristol Myers Squibb Hyderabad, India OTHERWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Clinical Data Specialist
6 days ago
Lifelancer Hyderabad, IndiaAbout TheRole · Yourresponsibilities include but are not limitedto: · Contribute to electronic CaseReport Form (eCRF) development with a thorough understanding ofdata to be collected and in alignment with theprotocol. · Support the assessment of new datacollection requirements in ...
-
Pharmacovigilance Scientist
1 week ago
Lifelancer Hyderabad, India Full timeAbout the job · For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new t ...
Manager, Pharmacovigilance - Hyderabad, India - Thermo Fisher Scientific
Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring.
As part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services.
Discover Impactful Work:
Coordinates contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. Manages the safety team on respective programs. Works with senior management, and develops consistent internal processes and ensures compliance with established processes. Proactively liaises with the Project Manager (as appropriate) and clients and ensures optimal performance and utilization of the safety project team.
A day in the Life:
Keys to Success:
Education
Experience
Knowledge, Skills, Abilities
Working Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.