Regulatory Affairs Associate – Pharmacovigilance
Nephron Pharmaceuticals, West Columbia, SC, United States
Company Overview
Nephron Pharmaceuticals Corporation is a privately owned global leader in the manufacturing of generic drug products, over‑the‑counter (OTC) drug products and medical devices. Nephron’s products are sterile, preservative and additive free and proudly made in the USA. We are headquartered in West Columbia, South Carolina and specialize in Blow‑Fill‑Seal (BFS) manufacturing, which allows a vial of medication to be formed, filled and sealed in a continuous sterile process without human intervention.
Position Summary
Receives, reports, and tracks adverse events and reactions for drug and device products.
Responds to requests for medically‑related product information.
Assists with additional work duties as needed.
Performs other duties as assigned or apparent.
Primary Accountabilities
Communicates directly with reporters regarding adverse event reports.
Evaluates adverse event reports and assesses regulatory status in conjunction with the medical consultant.
Processes ADE and MDR reports from clinical trials and marketed products in accordance with company procedures and regulatory requirements.
Performs risk assessment and trending on adverse event reports.
Plans and authors complex regulatory documents for submission to health authorities.
Participates in the preparation of aggregate safety reports (biannual safety reports to Ethics Committees, annual reports to regulatory authorities).
Researches and processes literature review reports per regulatory guidance.
Provides support to the Regulatory Affairs Department by assisting with establishment renewal/registration/updates required through CDER Direct.
Manages and monitors government regulations, regulatory changes and communicates requirements.
Develops professional relationships with health authorities when required.
Ensures proper archival of documentation related to adverse events and communications with regulatory authorities.
Assists in training personnel and may supervise as appropriate.
Supports management with implementation of departmental strategies and policies.
Provides additional support to the Regulatory Affairs Department by assisting with organizational and research projects as needed.
Knowledge, Skills & Abilities Relevant scientific degree (PharmD or RN preferred) with at least 2 years additional clinical or pharmaceutical experience. Experience in Drug Safety and Regulatory Affairs strongly preferred.
Ability to read, analyze, and interpret complex scientific and medical reports, journals, and government regulations and guidance documents.
Excellent written and verbal communication skills, and ability to present information to regulatory authorities.
Ability to write submissions and regulatory correspondence that conforms to prescribed style and format.
Critical thinking skills and ability to follow‑through.
Excellent organizational skills and attention to detail.
Ability and willingness to change direction and focus to meet shifting organizational and business demands, including multi‑tasking and meeting strict deadlines.
Experience with Adobe Acrobat, Excel, PowerPoint, and Word, and ability to learn new computer programs.
Experience working with confidential, controlled documents.
Position requires bending (desk to floor), lifting (up to 15 lbs), vision (20/20), standing (5%), sitting (90%), typing (80%) and walking (5%).
Salary range: Based on experience.
EEO Statement Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.
Nephron Pharmaceuticals is a drug‑free workplace.
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Position Summary
Receives, reports, and tracks adverse events and reactions for drug and device products.
Responds to requests for medically‑related product information.
Assists with additional work duties as needed.
Performs other duties as assigned or apparent.
Primary Accountabilities
Communicates directly with reporters regarding adverse event reports.
Evaluates adverse event reports and assesses regulatory status in conjunction with the medical consultant.
Processes ADE and MDR reports from clinical trials and marketed products in accordance with company procedures and regulatory requirements.
Performs risk assessment and trending on adverse event reports.
Plans and authors complex regulatory documents for submission to health authorities.
Participates in the preparation of aggregate safety reports (biannual safety reports to Ethics Committees, annual reports to regulatory authorities).
Researches and processes literature review reports per regulatory guidance.
Provides support to the Regulatory Affairs Department by assisting with establishment renewal/registration/updates required through CDER Direct.
Manages and monitors government regulations, regulatory changes and communicates requirements.
Develops professional relationships with health authorities when required.
Ensures proper archival of documentation related to adverse events and communications with regulatory authorities.
Assists in training personnel and may supervise as appropriate.
Supports management with implementation of departmental strategies and policies.
Provides additional support to the Regulatory Affairs Department by assisting with organizational and research projects as needed.
Knowledge, Skills & Abilities Relevant scientific degree (PharmD or RN preferred) with at least 2 years additional clinical or pharmaceutical experience. Experience in Drug Safety and Regulatory Affairs strongly preferred.
Ability to read, analyze, and interpret complex scientific and medical reports, journals, and government regulations and guidance documents.
Excellent written and verbal communication skills, and ability to present information to regulatory authorities.
Ability to write submissions and regulatory correspondence that conforms to prescribed style and format.
Critical thinking skills and ability to follow‑through.
Excellent organizational skills and attention to detail.
Ability and willingness to change direction and focus to meet shifting organizational and business demands, including multi‑tasking and meeting strict deadlines.
Experience with Adobe Acrobat, Excel, PowerPoint, and Word, and ability to learn new computer programs.
Experience working with confidential, controlled documents.
Position requires bending (desk to floor), lifting (up to 15 lbs), vision (20/20), standing (5%), sitting (90%), typing (80%) and walking (5%).
Salary range: Based on experience.
EEO Statement Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.
Nephron Pharmaceuticals is a drug‑free workplace.
#J-18808-Ljbffr