Pharmacovigilance Science Expert
English
₹15000/MONTH
1 Year
Bachelor's (Preferred)
Work From Office
Date Posted
17-Apr-2025
Location
Delhi (DL), 1
Job Type
Full Time
Company
Group
Description
???? Job Title: Pharmacovigilance Science Expert
????️ Job Type: Permanent
???? Location: Hyderabad, India
???? Company Overview:
This global role supports a dynamic and culturally diverse international team dedicated to safety surveillance throughout the product lifecycle of a wide range of pharmaceutical products.
???? Role Summary:
As a Pharmacovigilance (PV) Science Expert, you will be responsible for performing core PV activities in collaboration with Global Safety Leads/Managers (GSLs/GSMs), including signal detection, safety evaluations, regulatory support, and cross-functional coordination for both marketed and clinical development products.
????️ Main Responsibilities:
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Conduct ongoing signal detection activities using multiple data sources (PV database, literature, external databases).
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Coordinate and author Health Hazard Evaluations (HHEs) and Safety Evaluation Reports (SERs).
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Manage data entry and tracking of safety signals, medical events (ME), and individual case reports (INR) in the SMART tool.
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Review and interpret signal detection reports (NINR, UDR, SD reports for PBRERs).
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Draft and coordinate responses to Health Authority (HA) queries with the Safety Team.
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Serve as a core member of the Safety Management Committee (SMC) and contribute to data analysis and presentation.
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Support safety content development for regulatory filings (e.g., new drug applications, EU RMPs).
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Assist in benefit-risk assessments for marketed products and coordinate related meetings and follow-ups.
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Collaborate with multiple stakeholders including PV Quality, Medical Safety, QPPV, Regulatory Affairs, and vendors.
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Contribute to OTC SWITCH SER support, training new PV safety scientists, and supporting audits/inspections.
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Serve as lead point-of-contact for PV-related projects and deliverables.
???? Required Experience:
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5–8 years of industry experience in pharmacovigilance, drug safety, or risk management.
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Working knowledge of drug development, regulatory guidelines, and medical coding systems.
???? Skills & Competencies:
Soft Skills:
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Strong stakeholder management and negotiation skills.
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Effective communication in global, cross-functional environments.
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Project management and strategic thinking abilities.
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High attention to detail and strong problem-solving skills.
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Ability to mentor, collaborate, and lead initiatives.
Technical Skills:
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Expertise in signal detection, risk management, and safety data evaluation.
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Familiarity with US/EU PV regulatory requirements and international standards.
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Proficient in SMART tools, safety databases, and document management systems.
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Experience preparing for and supporting audits and inspections.
???? Education & Language:
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Degree in a healthcare/scientific discipline such as M.Pharm, MHS, MBBS, BDS, or equivalent.
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Fluent in English (written and verbal).
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