Sr.Officer/Executive - Pharmacovigilance Hetero Labs Limited

2.0 - 4.0 years

0 Lacs

hyderabad, telangana, india

On-site

Experience in handling various aggregate reports including PADERs, PSURs/PBRER, ACOs. Experience in running routine signal detection process, including review of individual case reports, literature review in coordination with QPPVs/safety physicians. Coordination and good communication with cross functional teams. Required Qualification : B.Pharmacy/M.Pharmacy/Pharma.D

Posted 6 days ago

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Senior Medical Safety Physician Apcer Life Sciences

3.0 - 8.0 years

14 - 20 Lacs

ahmedabad, delhi / ncr

Hybrid

Medical Review aggregate reports (PSUR, PBRER, ADCO & DSUR) and screening of scientific literature for periodic submission as per the Regulations and SOPs. Manage daily workload in conjugation with line manager for aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department. Generation and review of SOPs and WIs and execution of company SOPs. Compliance to project guidelines • Execution of Company Standard Operating Procedures Maintain awareness of changes to/new regulations affecting PVG activities. Trains and mentors new medical reviewers in PVG (if required). To carry out necessary administrative duties required for the job. Other duties as assigned by ma...

Posted 3 weeks ago

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Assistant Manager/Deputy Manager-Pharmacovigilance Hetero Labs Limited

8.0 - 10.0 years

0 Lacs

Hyderabad / Secunderabad, Telangana, Telangana, India

On-site

Minimum of 8 years experience in handling Aggregate reports such as PBRERs/PSURs, PADERs, RMP and Signal Management reports. To lead the aggregate reporting team, and to schedule and ensure regulatory compliance in preparation, review and reporting of aggregate reports (PADERs andPBRERS/PSURs), signal reports, risk management plan reports. To oversee the assignment of activities within the team and ensure the timely delivery and appropriate quality oversight of aggregate reports. Ensure tasks are performed as per applicable procedures (e.g., WI, SOPs) assigned to the role. To provide response to the regulatory queries on safety topics and relevant documents in support to content of safety. Q...

Posted 3 months ago

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Executive/Senior Executive Pharmacovigilance- Hyderabad Hetero

3.0 - 6.0 years

1 - 6 Lacs

Hyderabad

Work from Office

Role & responsibilities To prepare and review and reporting of aggregate reports (PADERs and PBRERS/PSURs), signal reports, risk management plan reports. To oversee the assignment of activities within the team and ensure the timely delivery and appropriate quality oversight of aggregate reports. Ensure tasks are performed as per applicable procedures (e.g., WI, SOPs) assigned to the role. To provide response to the regulatory queries on safety topics and relevant documents in support to content of safety. To liaise with cross-functional departments such as Regulatory Affairs and Medical Review to ensure seamless coordination of safety-related activities. To establish and maintain effective c...

Posted 3 months ago

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Pharmacovigilance Scientist Propharma Group

2.0 - 4.0 years

6 - 8 Lacs

bengaluru

Hybrid

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. Role & responsibilities 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 pa...

Posted Date not available

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