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6.0 - 10.0 years

10 - 15 Lacs

Pune, Mumbai (All Areas)

Work from Office

Naukri logo

Hi, We are hiring for Leading ITES Company for Aggregate Report Writer Profile. Please Apply, We shall call back relevant profiles. Role & responsibilities: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.). To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

Posted 2 weeks ago

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3.0 - 8.0 years

2 - 6 Lacs

Noida, Uttar Pradesh, India

On-site

Foundit logo

We are seeking a dedicated and detail-oriented Executive in Pharmacovigilance to join our team in India. The ideal candidate will have experience in monitoring drug safety and ensuring compliance with regulatory requirements. Responsibilities Monitor and evaluate adverse drug reactions and safety data from various sources. Prepare and submit periodic safety reports to regulatory authorities. Collaborate with cross-functional teams to ensure compliance with pharmacovigilance regulations. Conduct signal detection and risk management activities. Maintain up-to-date knowledge of pharmacovigilance guidelines and best practices. Skills and Qualifications Bachelor's degree in Pharmacy, Life Sciences, or related field; Master's degree preferred. 3-8 years of experience in pharmacovigilance or drug safety. Strong knowledge of ICH/GCP guidelines and regulatory requirements. Proficiency in data analysis and interpretation of safety data. Excellent communication and interpersonal skills. Attention to detail and strong organizational skills.

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10 - 12 years

32 - 35 Lacs

Pune

Remote

Naukri logo

CLINIMINDS IS RECRUITING THIS POSITON FOR THE THE US BASED GLOBAL PHARMA CONSULTING AND PHARMACOVIGILANCE FIRM Role & responsibilities The Associate Director will lead the medical evaluation of Individual Case Safety Reports (ICSRs), oversee the clinical review of aggregate safety reports (e.g., PBRERs, DSURs, ACOs), and provide strategic and medical input in signal detection and benefit-risk assessments for the companys product portfolio, including biosimilars. The role ensures compliance with global regulatory requirements and drives excellence in pharmacovigilance science. ICSR Medical Review Aggregate Report Review Signal Management Cross-functional Collaboration Preferred candidate profile PEOPLE LEADER The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position. An individual in this position must be able to successfully perform the expectations listed above. MINIMUM KNOWLEDGE, SKILLS, AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. Education (MBBS/ MD) or comparable education. Experience and/or Training: A minimum of 10 years of drug safety experience. Should have valuable experience in literature review for both Pre-authorization and Post marketing products. Should have valuable experience in reviewing aggregate reports and signal management activities. Technology/Equipment (Microsoft Proficient).

Posted 1 month ago

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- 1 years

2 - 3 Lacs

Lucknow

Hybrid

Naukri logo

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

Posted 1 month ago

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- 1 years

2 - 3 Lacs

Coimbatore

Hybrid

Naukri logo

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

Posted 1 month ago

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- 1 years

2 - 3 Lacs

Nagpur

Hybrid

Naukri logo

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

Posted 1 month ago

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- 1 years

2 - 3 Lacs

Kanpur

Hybrid

Naukri logo

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

Posted 1 month ago

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- 1 years

2 - 3 Lacs

Jaipur

Hybrid

Naukri logo

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

Posted 1 month ago

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- 1 years

2 - 3 Lacs

Hyderabad

Hybrid

Naukri logo

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

Posted 1 month ago

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- 1 years

2 - 3 Lacs

Chennai

Hybrid

Naukri logo

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

Posted 1 month ago

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- 1 years

2 - 3 Lacs

Pune

Hybrid

Naukri logo

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

Posted 1 month ago

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- 1 years

2 - 3 Lacs

Bengaluru

Hybrid

Naukri logo

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

Posted 1 month ago

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- 1 years

2 - 3 Lacs

Surat

Hybrid

Naukri logo

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

Posted 1 month ago

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- 1 years

2 - 3 Lacs

Kolkata

Hybrid

Naukri logo

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

Posted 1 month ago

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- 1 years

2 - 3 Lacs

Ahmedabad

Hybrid

Naukri logo

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

Posted 1 month ago

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- 1 years

2 - 3 Lacs

Mumbai

Hybrid

Naukri logo

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

Posted 1 month ago

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6 - 10 years

10 - 15 Lacs

Pune, Mumbai (All Areas)

Work from Office

Naukri logo

Hi, We are hiring for Leading ITES Company for Aggregate Report Writer Profile. Please Apply, We shall call back relevant profiles. Role & responsibilities: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.). To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Posted 1 month ago

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6 - 10 years

10 - 15 Lacs

Pune, Mumbai (All Areas)

Work from Office

Naukri logo

Hi, We are hiring for Leading ITES Company for Aggregate Report Writer Profile. Please Apply, We shall call back relevant profiles. Role & responsibilities: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.). To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Posted 1 month ago

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6 - 10 years

8 - 15 Lacs

Pune, Mumbai (All Areas)

Work from Office

Naukri logo

Hi, We are hiring for Leading ITES Company for Aggregate Report Writer Profile. Please Apply, We shall call back relevant profiles. Role & responsibilities: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.). To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Posted 2 months ago

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4 - 6 years

3 - 8 Lacs

Navi Mumbai, Mumbai (All Areas)

Work from Office

Naukri logo

Role Brief: Incumbent will be a part of the SERM team, working on SERM related activities. The Safety Evaluation and Risk Management (SERM) group within GPV is responsible for the scientific evaluation of safety information and the continuous monitoring of the benefit-risk profile of all Glenmark products throughout all stages of the product lifecycle. The SERM works to ensure that Glenmark is compliant with global legislation and guidelines that govern the development, registration and commercialization of its medicines. The SERM scientist is responsible for all safety evaluation and risk management activities for Glenmark products including (but not limited to) the preparation of safety reports, risk management plans and signal assessments. Role & responsibilities: 1) Author/ review/ approve drug safety reports 2) Contribute to the development and implementation of Risk Management Plans 3) Perform signal detection, evaluation and overall signal management activities 4) Lead or participate in cross-functional safety review teams for products in clinical development 5) Review and provide input into safety sections of study related documents 6) Respond to regulatory authority/healthcare professionals queries for assigned products 7) Review literature search results for ICSRs and articles for inclusion in safety reports 8) Liaise and collaborate with other GPV functions, international Glenmark affiliates and external business partners 9) Support product labelling activities 10) Support audits, inspection and CAPA management relating to SERM activities 11) Support assessment and implementation of regulatory intelligence findings that impact SERM activities 12) Provide technical guidance in the development and maintenance of procedural documentation 13) Support organizational initiatives in driving global operational excellence in Pharmacovigilance 14) Support the EEA QPPV 15) Clinical Trial support 16) Vendor Management 17) Website Monitoring Preferred candidate profile : 4 + years of experience within PV & SERM M.Pharm preferred

Posted 3 months ago

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