Drug Safety Associate
2 weeks ago
**Job Summary**
Responsible for providing medical and clinical insight and guidance through clinical trials for pharmaceuticals.
**Primary Responsibilities**
- Provide medical and clinical guidance to managers before, throughout, and following clinical trials.
- Maintain consistency of safety assessments.
- Perform a variety of safety assessments.
- Serve in cross-functional teams as a medical and scientific representative.
- Ensure regulatory compliance and safety throughout trial.
- Submit periodic reports to the Food and Drug Administration.
- Ensure that medical and causality assessments of all clinical and post-marketing adverse event fillings to foreign regulatory authorities are consistent with company policies, as well as the respective foreign regulatory requirements.
- Address labeling concerns and updates.
- Interpret regulatory mandates.
- Assist with internal and external drug safety audits
- Create company data sheets.
- Remediate any pharmacovigilance deficiencies found during regulatory or internal audits.
- Act as medical expert during product development.
- Establish and maintain consistency of safety assessments within the US and outside the US.
- Identify the correct actions and facilitate, support and implement them as appropriate.
- Review performance metric data and clarify inconsistencies and trends.
**Salary**: ₹282,922.63 - ₹1,035,191.88 per year
**Benefits**:
- Health insurance
Schedule:
- Day shift
- Morning shift
- Rotational shift
Supplemental pay types:
- Joining bonus
- Performance bonus
Ability to commute/relocate:
- Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
**Speak with the employer**
+91 9156086642
-
Drug Safety Associate
2 weeks ago
Pune, India Fusion Market Research Full timeDrug safety associates have a wide range of responsibilities, which can include: - Reviewing adverse event reports, safety data sheets, and physician advisories to identify potential risks associated with a particular drug - Conducting site visits to observe the distribution process to ensure compliance with federal regulations - Monitoring compliance with...
-
Drug Safety Associate
2 days ago
Kharadi, Pune, Maharashtra, India Vertex Solutions Pvt Ltd Full timeThe primary duty of a Drug Safety Associate involves the ongoing monitoring and evaluation of adverse effects and safety concerns associated with drugs and medical products following market approval. As a Drug Safety Associate, your responsibilities will include monitoring, assessing, and reporting adverse events related to pharmaceutical products. You will...
-
Drug Safety Associate
5 days ago
Pune, India Fusion Technology Solutions Full timeDrug safety experts have numerous responsibilities and this can vary from one company to another. The roles include activities like. - Processing and writing of adverse event program - Follow up on important case reports - Serving as a link between company and the patients or healthcare experts to provide valid information on product safety. - Conducting...
-
Drug Safety Specialist
Found in: Whatjobs IN C2 - 2 weeks ago
Pune, India Tata Consultancy Services Full timeTCS is hiring for PV Drug Safety! Role: Pharmacovigilance Work location: Mumbai Experience: 1 - 7 years’ relevant experience in Pharmacovigilance Qualification: Bpharm/ Mpharm/ BHMS/ BAMS/ BDS/ Msc (Biotechnology, Zoology) Job Description: *Ability to understand and analyses the complex data and performs the activities including accessing the case in...
-
Drug Safety Specialist
Found in: Appcast Linkedin IN C2 - 2 weeks ago
Pune, India Tata Consultancy Services Full timeTCS is hiring for PV Drug Safety!Role: PharmacovigilanceWork location: MumbaiExperience: 1 - 7 years’ relevant experience in PharmacovigilanceQualification: Bpharm/ Mpharm/ BHMS/ BAMS/ BDS/ Msc (Biotechnology, Zoology)Job Description:*Ability to understand and analyses the complex data and performs the activities including accessing the case in Argus, code...
-
Drug Safety Specialist
Found in: Talent IN 2A C2 - 2 weeks ago
Pune, India Tata Consultancy Services Full timeTCS is hiring for PV Drug Safety!Role: PharmacovigilanceWork location: MumbaiExperience: 1 - 7 years’ relevant experience in PharmacovigilanceQualification: Bpharm/ Mpharm/ BHMS/ BAMS/ BDS/ Msc (Biotechnology, Zoology)Job Description:*Ability to understand and analyses the complex data and performs the activities including accessing the case in Argus, code...
-
Drug Safety Specialist
Found in: Whatjobs IN C2 - 2 weeks ago
Pune, India The Hird Full timeRole – Drug Safety Physician.Designation – Sr. Executive.Location – Pune.Qualification – MBBS/MD (Pharmacology).Experience – 2 to 7 Years (ICSR)Mode - Work from Office. (Kolkata)Notice Period – Immediate joiners preferred.CTC- Upto 25 LPAPosition Purpose:To Analyze, Review and Interpret Safety data.Primary Responsibilities:To Perform medical...
-
Principal Consultant- Argus Drug Safety Migration expert
Found in: Talent IN C2 - 3 weeks ago
Pune, India Oracle Full timeJob Description `Overview of the Organization Oracle Life Sciences GIU (LSGIU) provides industry leading solution to Life Sciences organizations including pharmaceutical companies, CROs (Contract research Organizations), Academic research and Healthcare providers that include care providers, IDN (integrated delivery networks), public regional/national...
-
Pharmacovigilance Associate
2 weeks ago
Pune, India Refined Reports Data Full timeA pharmacovigilance associate ensures compliance with applicable regulations or standard operating procedures; specialises in drug safety management, clinical trials and medical supervision. - Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and...
-
Drug Safety Specialist
Found in: Appcast Linkedin IN C2 - 2 weeks ago
Pune, India The Hird Full timeRole – Drug Safety Physician.Designation – Sr. Executive.Location – Pune.Qualification – MBBS/MD (Pharmacology).Experience – 2 to 7 Years (ICSR)Mode - Work from Office. (Kolkata)Notice Period – Immediate joiners preferred.CTC- Upto 25 LPAPosition Purpose: To Analyze, Review and Interpret Safety data. Primary Responsibilities:To Perform medical...
-
Drug Safety Specialist
Found in: Talent IN 2A C2 - 2 weeks ago
Pune, India The Hird Full timeRole – Drug Safety Physician.Designation – Sr. Executive.Location – Pune.Qualification – MBBS/MD (Pharmacology).Experience – 2 to 7 Years (ICSR)Mode - Work from Office. (Kolkata)Notice Period – Immediate joiners preferred.CTC- Upto 25 LPAPosition Purpose: To Analyze, Review and Interpret Safety data. Primary Responsibilities:To Perform medical...
-
Drug Safety Specialist
Found in: Whatjobs IN C2 - 2 weeks ago
Pune, India The Hird Full timeRole – Drug Safety Physician. Designation – Sr. Executive. Location – Pune. Qualification – MBBS/MD (Pharmacology). Experience – 2 to 7 Years (ICSR) Mode - Work from Office. (Kolkata) Notice Period – Immediate joiners preferred. CTC- Upto 25 LPA Position Purpose: To Analyze, Review and Interpret Safety data. Primary...
-
Pharmacovigilance Associate
7 days ago
Pune, India Refined Reports Data Full timePharmacovigilance associates have a wide range of responsibilities, which can include: - Preparing reports of adverse drug reactions that may involve complex medical terminology, medical chart reviews, and statistical analyses - Responsible for monitoring potential side effects of drugs being marketed in the United States by reviewing case studies and...
-
Pune, India Deloite Software Pvt Ltd Full time**Typical Responsibilities Include** - Recording and reporting adverse reactions received from healthcare professionals and consumers - Conducting in-depth interviews with patients and healthcare professionals - Developing a thorough knowledge of products - Completing periodic safety update reports on drugs and other treatments - Writing and reviewing...
-
Pharmacovigilance
2 days ago
Pune, India Refined Reports Data Full timeA pharmacovigilance associate ensures compliance with applicable regulations or standard operating procedures; specialises in drug safety management, clinical trials and medical supervision. - Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and...
-
Subject Matter Expert
6 days ago
Pune, India Labcorp Full timeLabcorp Drug Development As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired...
-
Pharmacovigilance Associate
3 days ago
Pune, India Refined Reports Data Full timePreparing reports of adverse drug reactions that may involve complex medical terminology, medical chart reviews, and statistical analyses - Responsible for monitoring potential side effects of drugs being marketed in the United States by reviewing case studies and medical literature - Assisting in processing insurance claims for drug products dispensed by...
-
Pharmacovigilance Associate
2 weeks ago
Pune, India Bitwise Solutions Full timePreparing reports of adverse drug reactions that may involve complex medical terminology, medical chart reviews, and statistical analyses - Responsible for monitoring potential side effects of drugs being marketed in the United States by reviewing case studies and medical literature - Assisting in processing insurance claims for drug products dispensed by...
-
Safety Physician
1 week ago
Pune, India Labcorp Full timeLabcorp Drug Development As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired...
-
Safety writer
Found in: Talent IN C2 - 2 weeks ago
Pune, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...