Pharmacovigilance Specialist Resume

CAREER OBJECTIVE:

Seeking a challenging career in an organization that promotes growth, stability and opportunity for advancement in the field of Pharmacovigilance.

JOB SUMMARY:

Pharmacovigilance Professional with 3 years of experience in capturing and assessing single adverse event reports associated with client products on a worldwide basis on the client's drug safety database, in accordance with international and local regulatory requirements.
Successfully faced multiple client audits.
Strong knowledge of MedDRA, WHO Drug Dictionary and coding practices.
Thorough understanding of adverse event reporting and safety databases.
Good understanding of the quality and confidentiality of patient data and process involved in processing the data to make it presentable as per regulatory requirements.
Good knowledge and understanding of the standard operating procedures and abiding by the guidelines.
Excellent interpersonal communication, organizational and leadership skills.
Good at handling modules independently and as a team.
Excellent verbal and written communication skills.
Proficient in MS Word, MS Excel, MS Outlook and MS PowerPoint presentations.
Good time management and ability to work under pressure.
Multi - tasking ability and attention to detail.
Managed Individual Case Safety Reports of all case types (serious and non - serious cases from spontaneous and solicited programs, literature and E2B cases, which included:
Triage of Confidential to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities.
Conducting duplicate searches prior to initiation and identifying potential duplicates.
Initiating/Registering of Confidential into the safety database.

PROFESSIONAL EXPERIENCE:

Pharmacovigilance Specialist

Confidential

Responsibilities:

Assessed labeling of serious adverse events originating from spontaneous, clinical sources with reference to IB, CCDS, SmPC, and USPI.
Ensured Confidential coding
Hands-on expertise in end to end Case Processing in Pharmacovigilance database ARISg.
Assisted in upgrading or downgrading of case, where applicable based on the medical assessment and seriousness criteria.
Quality Check of Confidential which included review of source documents and ensuring that the case is accurate, correct and complete.
Maintained a good working knowledge of the AE safety profile of assigned drugs, reference Safety Information documents, data entry conventions and guidelines, clients' procedures and international drug safety regulations including:

Confidential

Pharmacovigilance Analyst

Responsibilities:

Maintained an awareness of global regulatory reporting obligations and organized workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
Drafted individual case summary reports and wrote concise case specific narratives as per company/product conventions.
Processed literature cases which included cases from medical journals abstracts, poster presentation, literature summary cases and full literature articles.
Sound knowledge of 21 CFR Parts 11/312/314, MHRA best practices and ICH recommendations.
Communicated with clients regarding case related queries and follow up.
Attended project team meetings and client calls related to the project.
Worked in different therapeutics areas like Parkinson's disease, Alzheimer's disease, Breast cancer, Prostate cancer.
Experienced in French Imputability method of causality assessment.
Knowledge of aggregate reports including PSURs/PBRERs, PADER, and Clinical trials protocol, Informed Consent, Investigator Brochure (IB).
Requested and provided follow-ups on adverse events by preparing, sending out and tracking queries.
Experienced in handling the ERP (Enterprise Resource Planning) system.
As mentor, trained new team members on safety data processing and project related activities.

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