6,293 Safety Scientist jobs in India

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 therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

Job Summary
The Pharmacovigilance (PV) Scientist supports the activities in the Benefit Risk group by ensuring that day-to-day operational activities are completed. The PV Safety Scientist is expected to be professional and diligent and liaise with the director and management group members within the team on any issues, as well as coordinate the work with the senior PV Scientists. The PV Safety Scientist is also expected to lead by example and ensures quality standards are upheld within the company.

Essential Functions

• Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities.
• Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
• Authoring of Signal Management Reports.
• Performing literature search and validity check for the aggregate reports.
• Reconciliation of relevant process trackers.
• Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).
• Generation of Line Listings (LL) from safety database
• Providing reliable support for high priority Ad-hoc activities.

Necessary Skills And Abilities.

• Analytical and problem-solving skills.
• Sound organizational skills
• Able to work within a team in an open and professional manner
• Excellent attention to detail and focus on quality
• Understanding of ICH-GCP, FDA, EMA and other relevant Global regulations related to PV
• Demonstrable ability to analyze and quantify large volumes of data in a concise and scientific manner, in keeping with regulatory deadlines.
• Awareness of global culture and willingness to work in a matrix environment
• Knowledge in other pharmacovigilance processes, ability to author/update SOPs or WIs, to identify and author deviations/CAPAs."
• Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines.
• Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
• Computer proficiency, IT skills, expertise and an ability to work with web based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)

Educational requirements

• Bachelor/master's degree in pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience

Experience Requirements

• 2+ years' experience in Pharmacovigilance with a focus on medical writing and/or literature search and/or signal detection
• Experiences in contributing to the compilation of metrics and participating in discussions about quality internally and with Clients
• Experience in literature screening activities and/or experiences in authoring and reviewing aggregate reports

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

TCS is Hiring -Clinical Safety Scientist

location - Mumbai, Noida, Bengaluru

Experience Range - 5 to 10

Preferred Educational Qualification for the role - Any life science Graduate

Job Description

Literature Review

Literature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports).

Provide MAH comments for selected literature

Review of Literature Strategy

Design and interpretation of various types of studies in medicine, levels of evidence, study power for the purpose of safety analyses.

Thesaurus used for indexing medical scientific literature, relevant for literature search strategy tailoring (both ad-hoc and systematic).

Review and interpretation of current expert therapeutic guidelines for the purpose of various safety analyses.

Review of outputs triaged by the safety scientist for scientific accuracy taking into consideration all of the above criteria

Aggregate Reports:

Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER.

Authoring of RMP updates & implementation plans.

Provides methodology (in collaboration with Roche clinical safety) for data presentation and assessment in the pertinent safety sections of the aggregate report (use outside the indication scope, use in special population, medication errors, characterization of risks etc.)

Asses the new information received on important safety concerns for the medicinal product.

Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy

Signal Management

Review of various types of listings for Signal Detection

Understanding of signal journey and knowledge of signal management systems and process requirements.

Perform Signal validation with a brief summary.

DSR - Complete authoring, Single case analysis & MAH comments, Drafting Overall Conclusion and Review

Tailoring strategy and methodology for signal assessment

Overall assessment of the signal based on the presented data and respective recommendation for action

Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy

Risk Assessment & Management

Ad-hoc in risk assessments

Responsible for identifying, assessing, and mitigating risks associated with IT systems, data, and operations.

certification:
•CISA , CISM,CCSP

Required Candidate profile

Exp: 4+YEARS

Loc: Mumbai-Andheri

np: 30 Days

Talworx is hiring!

Our client in India, a professional services firm, is the Indian member firm affiliated. Our professionals leverage the global network of firms, providing detailed knowledge of local laws, regulations, markets, and competition. Our client has offices across India in Ahmedabad, Bengaluru, Chandigarh, Chennai, Gurugram, Hyderabad, Jaipur, Kochi, Kolkata, Mumbai,

Noida, Pune, Vadodara, and Vijayawada.

Our client in India offers services to national and international clients in India across sectors. We strive to

provide rapid, performance-based, industry-focussed and technology-enabled services, which reflect a

shared knowledge of global and local industries and our experience of the Indian business environment.

Our professionals provide the experience to help companies stay on track and deal with risks that could

unhinge their business survival. Our services enable clients to effectively co-ordinate their key growth,

quality and operational challenges and working in partnership with us.

Requirements

Roles & Responsibility:

• Conduct thorough and detailed cyber risk assessments for our clients, analyzing their digital

infrastructure, systems, and security controls.

• Collaborate with cross-functional teams to gather essential information and data required for

comprehensive risk assessments.

• Evaluate and interpret assessment results to identify potential vulnerabilities and risks, and provide

actionable recommendations for risk mitigation.

• Stay up-to-date with the latest cyber threats, attack vectors, and industry best practices to enhance the

effectiveness of risk assessments.

• Prepare and deliver clear and concise reports summarizing the findings of risk assessments to clients

and internal stakeholders.

• Provide expert advice and consultancy to clients, guiding them in implementing robust cybersecurity

risk management strategies.

• Mentor and support junior team members to foster their professional growth and skills in cyber risk

assessments.

Bachelor's or Master's degree in Computer Science, Cybersecurity, Information Technology, or related

fields.

• A minimum of 5+ years of hands-on experience in conducting cyber risk assessments and related

security assessments.

• Industry certifications such as CISSP, CCSP, CISA, CISM, CRISC, ISO/IEC:27001/22301/2000 LI/LA or

equivalent are highly valued.

• Profound knowledge of cybersecurity frameworks, industry standards, and best practices.

• Proficiency in using various security assessment and techniques.

• Strong analytical and problem-solving skills, with the ability to think critically and strategically.

• Excellent communication and presentation skills, capable of effectively communicating technical

concepts to both technical and non-technical audiences.

• Demonstrated experience in project management and handling multiple assessments simultaneously.

• A proactive and self-motivated approach to work, with a commitment to continuous learning and

professional development.

• Network Security, infrastructure assessment and network architecture design review.

• Conceptual knowledge of OT Security/ISA 62443 standard is preferable.

>> CRITERIA

o Education 60% above throughout academics

o One 3 years (at least) regular course is must either Diploma or Graduation

o Course: B.E. / B. Tech / MCA / M. Tech / MBA degree or equivalent

o Certification: CISM / CISSP / CCSP / CISA / CRISC / ITIL / ISO 27001/22301/2000 LI/LA (At least

one)

o CCNA (Mandatory), CCNP or equivalent(optional).

>> COMPENSATION

O Compensation is competitive with industry standards

o Details of the compensation breakup will be shared with short-listed candidates only

Benefits

Work with one of the Big 4's in India

Healthy work Environment

Work Life Balance

• Bachelor's degree or equivalent practical experience.
• 5 years of experience in data analysis, including identifying trends, generating summary statistics, and drawing insights from quantitative and qualitative data.
• 5 years of experience managing projects and defining project scope, goals, and deliverables.

• Master's or Ph.D. degree in a quantitative discipline (e.g., Computer Science, Statistics, Mathematics, Operations Research etc.)
• 5 years of experience in a large-scale data analysis or data science setting, including abuse and fraud disciplines, with a focus on web security, harmful content moderation and threat analysis.
• Experience scripting languages in (e.g., C/C++) with proficiency in programming languages (e.g., Python, Julia) and database languages like SQL.
• Experience with prompt engineering and fine-tuning LLMs.
• Proficiency in applying machine learning techniques to large datasets.

Trust & Safety team members are tasked with identifying and taking on the biggest problems that challenge the safety and integrity of our products. They use technical know-how, excellent problem-solving skills, user insights, and proactive communication to protect users and our partners from abuse across Google products like Search, Maps, Gmail, and Google Ads. On this team, you're a big-picture thinker and strategic team-player with a passion for doing what's right. You work globally and cross-functionally with Google engineers and product managers to identify and fight abuse and fraud cases at Google speed - with urgency. And you take pride in knowing that every day you are working hard to promote trust in Google and ensuring the highest levels of user safety.

The AI Safety Protections team within Trust and Safety develops and implements cutting-edge AI/LLM-powered solutions to ensure the safety of generative AI across Google's products. This includes safeguards for consumer products, enterprise offerings (Vertex AI), on-device applications, as well as foundational models (Gemini, Juno, Veo) in collaboration with Google DeepMind. We are a team of passionate data scientists and machine learning experts dedicated to mitigating risks associated with generative AI, and addressing real-world safety with LLM/AI technology (e.g., imminent threat, child safety).

As a member of our team, you will have the opportunity to apply the latest advancements in AI/LLM, work with teams developing cutting-edge AI technologies, as well as protecting the world from real-world harms.

This role works with sensitive content or situations and may be exposed to graphic, controversial, or upsetting topics or content.

• Develop scalable safety solutions for AI products across Google by leveraging advanced machine learning and AI techniques.
• Apply statistical and data science methods to examine Google's protection measures, uncover potential shortcomings, and develop actionable insights for continuous security enhancement.
• Drive business outcomes by crafting compelling data stories for a variety of stakeholders, including executive leadership.
• Develop automated data pipelines and self-service dashboards to provide timely insights at scale.

Google is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also Google's EEO Policy and EEO is the Law. If you have a disability or special need that requires accommodation, please let us know by completing our Accommodations for Applicants form.

1. The purpose of this role is to measure the customers risk exposures, analyze historical data and assist in determining the premium that needs to be charged to ensure that risk.

2. The individual will play an essential role in implementation of these projects from the prospect of our insurance domain.

3. Major responsibilities include analyzing customer data set and aggregating the risks of different lines of business (such as General Liability & Automobile Liability) with the help of prescribed tools and techniques.

4. Assessing the risks, and further segregating the various types of exposures amongst key factors such as state, territories, vehicle type, weight, radius, etc.

5. Accurately checking data discrepancies, and proactively highlighting them to the underwriters.

6. Summarizing the key findings, assumptions, and factors to keep in mind which would help Underwriters make accurate pricing decisions.

7. Working with risk assessment information and identifying data sources that can be used for making accurate pricing decisions.

8. Knowing relevant legal, regulatory, ethical, and social requirements with clients mandates and adhering to them while processing various accounts.

9. Contributing to the organizational values by actively engaging in the larger learning and development process.

10. Driving concise, structured, and effective communication with peers and clients.

Preferred candidate profile

1. Fundamental understanding of insurance, its key terminologies, and the insurance value chain as a whole

2. Awareness of the different kinds of insurance products within various lines of business (commercial and personal lines)

3. Awareness of basic underwriting criteria for a product or line of business.

4. Cognizant of how premium calculations work.

5. Valuable insights on policy extensions, limitations, and exclusions for business being underwritten.

6. Recognizes various concepts, jargons, products employed in underwriting and the insurance industry.

Skills

1. Proficient with MS Office.

2. Work with clients system for Underwriting.

Roles and Responsibilities

• * Conduct risk assessments to identify potential threats and vulnerabilities in the organization's IT systems, networks, and applications.
• * Develop and implement risk management strategies to mitigate identified risks, ensuring compliance with industry regulations such as HIPAA, PCI DSS, and ISO standards.
• * Collaborate with cross-functional teams to ensure effective implementation of security controls and monitoring of risk mitigation efforts.
• * Provide regular reporting on risk assessment findings and recommendations for improvement.

Desired Candidate Profile

• * 8-11 years of experience in Risk Management or a related field.
• * Strong understanding of Cyber Security, Information Security, and relevant industry regulations (HIPAA, PCI DSS).
• * Proven experience in conducting comprehensive risk assessments using various methodologies (e.g., NIST Cybersecurity Framework).
• * Certification in Risk Assessment or a related field (e.g., CISSP).