Job Title: Senior Pharmacovigilance Associate (Sr. PV Associate)
Experience Required: 3-5 years of relevant experience
Location: Mohali/Chandigarh
Compensation: 20-25% rise on current CTC
Key Responsibilities:
Drug Safety Management Support:
Provide technical and process-related support to drug safety management for both clinical trials and post-marketed products.
Ensure compliance with relevant regulations and Standard Operating Procedures (SOPs) throughout the pharmacovigilance processes.
ICSR Management:
Process Individual Case Safety Reports (ICSRs) from various sources including literature search and review.
Support signal detection and management, track regulatory information, and perform regulatory submissions.
Contribute to the preparation of aggregate safety reports, study reports, and other safety-related documentation.
Assist in Medical and Product Dictionary Management activities as required.
ICSR Compliance:
Ensure ICSR compliance with International and local regulatory reporting requirements.
Conduct quality review of ICSRs, generate relevant metrics, and investigate late case reports.
Maintain accurate tracking of cases and resolve any compliance-related issues.
Required Skills:
Strong experience in pharmacovigilance and drug safety management (both clinical trial and post-marketing).
Proficient in processing ICSRs and literature search/review.
Ability to perform signal detection, manage regulatory submissions, and ensure compliance with reporting requirements.
Knowledge of regulatory guidelines and SOPs in pharmacovigilance.
Gujarat :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Siliguri |Illinois :
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Netherlands |Remote Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
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Japan | Saitama |Tokyo :
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