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    Pharmacovigilance Safety Scientist

    Propharma
    1-2 years
    Not Disclosed
    India
    10 Aug. 7, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Pharmacovigilance (PV) Scientist

    Company: ProPharma Group

    About ProPharma:

    For over 20 years, ProPharma has been at the forefront of advancing patient health and wellness by providing expert consulting services to biotech, med device, and pharmaceutical organizations. As the world’s largest Research Consulting Organization (RCO), we partner with clients through an advise-build-operate model across the entire product lifecycle. Our comprehensive suite of consulting solutions in regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology is designed to de-risk and accelerate high-profile drug and device programs.

    Job Summary:

    The Pharmacovigilance (PV) Scientist plays a crucial role in the Benefit Risk group by ensuring the effective completion of daily operational activities. Reporting to the director and management team, this role involves coordinating work with senior PV Scientists and upholding quality standards within the company. The PV Safety Scientist is expected to lead by example and deliver high-quality results.

    Key Responsibilities:

    • Aggregate Reports: Author and review aggregate reports including PSURs, PBRERs, PADERS, Annual Reports, ACOs, and DSIJRs for submission to health authorities.
    • Risk Management Plans: Develop and author Risk Management Plans (RMPs) as part of routine pharmacovigilance activities.
    • Signal Management: Prepare Signal Management Reports and perform related activities.
    • Literature Review: Conduct literature searches, validate clinical and non-clinical literature, and perform duplicate searches.
    • Data Management: Reconcile process trackers and extract and validate data from safety databases.
    • Line Listings: Generate Line Listings (LL) from the safety database.
    • Ad-hoc Support: Provide reliable support for high-priority ad-hoc activities.
    • Audits and Inspections: Participate in internal and external audits/inspections as a Subject Matter Expert (SME) if required.
    • Compliance: Ensure deliverables comply with regulatory requirements and are submitted within agreed timelines.

    Essential Functions:

    • Draft PBRERs, PSURs, DSURs, PADERs, and Signal Reports.
    • Expert in literature validity checks and duplicate search for literature review.

    Skills and Abilities:

    • Proficient in Microsoft Office Suite (Outlook, Word, Excel).
    • Strong verbal, written, and interpersonal communication skills.
    • Excellent organizational and prioritization skills, with the ability to multitask.
    • Flexibility to adapt to changing business priorities.
    • Ability to work extended or flexible hours as needed to meet client requirements.

    Educational Requirements:

    • Bachelor’s Degree in a biological or natural science required; Advanced degree (PhD, BPharm, BDS, MPharm, PharmD) preferred.

    Experience Requirements:

    • Preferred: 1-2 years of experience in authoring aggregate reports and literature search/review in pharmacovigilance.

    Diversity and Inclusion:

    ProPharma celebrates diversity and strives to create an inclusive workplace where everyone can be their authentic selves. We are committed to diversity, equity, and inclusion and provide a safe space where all employees are empowered to succeed.

    Application Instructions:

    Please note that ProPharma Group does not accept unsolicited resumes from recruiters or third parties. Do not call or email regarding this posting.

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