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Work as Affiliate Safety Representative at Abbott India Limited | M.Pharm, M.Sc, B.Pharm - experienced candidates only

 

Clinical courses

Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.

Post : Affiliate Safety Representative

Job Description
Primary Job Function
Fulfill National Regulatory Authority regulations with respect to Pharmacovigilance (PV), and conform to Abbott standards.

Core Job Responsibilities:
Ensures local processes and procedures are in place to clearly define Pharmacovigilance responsibilities within the Affiliate in line with Global SOPs and local regulations
Develop and update SOPs as required by Medical Division for process improvement and simplification.

 

Position Accountability/Scope:
Compliance
Ensures a local tracking system is in place, to ensure timely submissions of adverse events to Abbott Global Pharmacovigilance (GPV), and of  ICSRs and Periodic Reports to the Regulatory Authority Reports monthly compliance metrics to GPV within the required timelines Maintains awareness of local PV legislation Ensures GPV/ QPPV is promptly notified of any changes to relevant Local Legislation Co-ordinates Affiliate review and submission of periodic safety reports Completes monthly ICSR reconciliation with interacting departments and/or partner companies (if applicable) and acts upon any discrepancies Ensures any changes to Affiliate safety personnel are communicated to the Regulatory Authority (if required by national legislation), GPV in a timely fashion.

Adverse event processing
Ensures that local processes, procedures and systems are in place for recording, processing, conducting follow up and translating adverse events from spontaneous and solicited sources and SAEs from clinical studies (where applicable), including pregnancy, overdose, misuse, abuse, medication errors or product quality complaint reports (in association with QA). Ensures local language medical or scientific literature, not included in GPV global literature review, social media (if applicable) are reviewed to identify possible adverse events, and that any reports are forwarded in a timely manner to GPV.

 

Product Complaintst
Ensures product complaints received by affiliate are reviewed for adverse events, and forwards any AEs identified to GPV Completes reconciliation between QA and PV at the Affiliate, ensuring that all ICSRs have been identified

Safety Data Exchange (SDE) Agreements
Ensures content of local agreements is in line with Abbott standards Maintains compliance with local agreements, including reconciliation between partner companies. Ensure the content of local SDE agreements conforms to Abbott standards and local requirements. Submits all local SDEAs to GPV for approval prior to finalisation. Ensures a local tracking system is in place, to monitor compliance to local safety data exchange agreement timeframes.

Training
Maintains a version-controlled training matrix for local PV personnel Ensures training of affiliate personnel on relevant PV responsibilities is undertaken on at least an annual basis, and that appropriate training records are maintained. Ensures that any training of partner company staff is completed according to local contract requirements, and appropriately documented.

Audits and Inspections
Acts as the key Affiliate contact for both internal audits and Regulatory Authority inspections. Ensures that any Regulatory Authority communications are forwarded to the required GPV personnel and that any corrective actions are completed according to schedule.

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Risk management (RM)
If applicable, local implementation and tracking of RMP activities resulting from Global RMPs.

Safety Monitoring
Monitors the risk/benefit profile of local products and communicates changes or concerns to Global Pharmacovigilance (GPV) for evaluation

 

After Hours Availability
Ensures that an after hours process is in place and tested (e.g., to respond to Regulatory Authority questions and for emergency un-blinding of treatment codes for Abbott sponsored studies). Maintains up- to-date information on local Regulatory Authority out of hours contacts.

Note - Only medical / pharmacy / life science graduates or post graduates with relevant experience in pharmacovigilance (3-5 Years) are eligible to apply.

Additional Information
Qualification : B.Pharm, B.Sc,
M.Pharm, M.Sc
Location : Mumbai
Industry Type : Pharma
Functional Area : R&D
JOB ID : 30889137
End Date : 20th August, 2018

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