Drug Safety Physician

3 days ago

Remote, India cGxPServe Full time

**Responsibilities**:

- Monitor patient safety during clinical trials by reviewing adverse events, SAEs, and providing medical assessments.
- Ensure timely and accurate reporting of SAEs and safety signals to regulatory authorities.
- Provide medical expertise to clinical study teams, investigators, and safety personnel for safety
- related queries and escalations.
- Lead or participate in the assessment of causality, expectedness, and severity of adverse events.
- Oversee the development of risk management plans and ensure compliance with REMS (Risk Evaluation and Mitigation Strategies).
- Support the preparation of safety documents, including DSURs, PSURs, and safety narratives.
- Participate in regulatory inspections and audits, ensuring safety systems and databases (e.g., Argus, ArisGlobal) are compliant and up to date.
- Analyze clinical trial safety data; present at Data Safety Monitoring Board (DSMB) meetings.
- Contribute to signal detection and risk-benefit analysis by reviewing empirical data and literature.
- Ensure compliance with standard operating procedures, Food and Drug Administration and World Health Organization regulations and global regulations for the reporting of adverse events to regulatory agencies.
- Review experimental protocols and informed consent documents; prepares, reviews, and edits presentations regarding safety review committee meetings.
- Maintain/update agent-specific clinical and preclinical toxicity study summary tables for investigational agents.
- Develop and Implement Safety Management Plan and Medical Monitoring Plan.

**Requirements**:

- Knowledge of regulatory guidelines (FDA, EMA, ICH, GCP) and safety reporting regulations (e.g., E2B, MedWatch, CIOMS).
- Proficiency in MedDRA coding and adverse event classification (e.g., CTCAE, DAIDS).
- Experience in handling serious adverse events (SAEs), signal detection, and risk management.
- Medical degree (MD, DO, or equivalent) is required.
- Board certification in a relevant field (e.g., internal medicine, pediatrics, or subspecialties like immunology or oncology) is often preferred.
- Experience in pharmacovigilance and clinical trials, with 5-10 years in safety monitoring or clinical research roles.
- 2 or more years of clinical research and/or experience as principal investigator, medical monitor.
- 2 or more years of clinical practice; experience in oncology, internal medicine, infectious diseases a plus.
- Strong communication and problem-solving skills for interacting with study teams, investigators, and regulatory authorities.
- Excellent written and verbal communication skills, with experience in medical writing and safety documentation.
- Strong analytical and problem-solving skills, with the ability to interpret and summarize complex safety and medical research data.
- Experience in training and mentoring junior staff is a plus.

Pay: ₹150,000.00 - ₹300,000.00 per month

Schedule:

- UK shift

Work Location: Remote

  • Drug Safety Associate Ii

    1 day ago

    Remote, India Parexel Full time

    **Job ID** R0000031576 **Category** Medical Sciences **ABOUT THIS ROLE**: **Job Purpose**: - The Drug Safety Associate II, will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures...

  • Drug Safety Specialist

    1 week ago

    Remote, India Parexel Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Primary Location: India, RemoteJob ID R Category Medical SciencesABOUT THIS ROLEKey Accountabilities:The below responsibilities vary as per applicable as per the job role.GeneralMaintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client's guidelines, and SOPs, and Global drug safety...

  • Drug Safety Specialist

    1 week ago

    India-Hyderabad-Remote Parexel Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...

  • Safety & Pv Submission Spec Ii

    1 day ago

    Remote, India Syneos - Clinical and Corporate - Prod Full time

    **Description** **Senior Safety & Pharmacovigilance Submissions Specialist** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model...

  • Case Medical Safety Expert

    1 day ago

    Remote, India IQVIA Full time

    Major duties and responsibilities: - oversees the Medical Review (MR) of ICSRs as per predefined activity and job-role in PV safety database, with special focus on case medical accuracy and documentation, - maintains overall accountability for the timeliness and quality of medical case management activities outsourced to service providers, - leads or...

  • Consultant - Veeva Safety - Managed Services

    2 weeks ago

    Remote, India Veeva Systems Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Team: Professional ServicesCountry: IndiaRemote Work Available: YesVeeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential...

  • Principal Safety

    5 days ago

    Remote, India Syneos Health Clinical Full time

    **Description** **Principal Safety & Pharmacovigilance Specialist** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide...

  • Doctor (General Physician)

    1 day ago

    Remote, India ZYLA Health Full time

    Zyla Health is India’s highest-rated personalized care management platform focused on improving health outcomes. Zyla enables care at scale for insurers and employers through its human-assisted AI on the 24x7 conversational Zyla app (consistently rated 4.7+). Some of our clients include Aditya Birla, Max Life, Care Insurance, HDFC Ergo, IBM, Godrej, Jindal...

  • Medical Advisor

    1 day ago

    Remote, India ProductLife Group Full time

    We are looking for a Team lead/ Manager/ senior medical advisor/reviewer proficient in all aspects of clinical and post-marketing drug safety. **Responsibilities**: Clinical Phase: - Lead as a medical monitor/Medical expert - Medical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as...

  • Clinical Program Scientist

    1 week ago

    Remote, India Compile Full time

    Job ID JR0120661 Category Medical Programs Specialist, Medical & Medical Research **It’s More Than a Career, It’s a Mission.** **Our Mission** People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate...