Pharmacovigilance Manager

10+ years

Not Disclosed

Bengaluru Hyderabad

10 Jan. 28, 2025

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 Manager
Location: Bangalore/Hyderabad
Company: Clinchoice
Experience: 10+ Years

Job Description:

Clinchoice is seeking a highly experienced and dedicated Pharmacovigilance Manager to join our dynamic team. The ideal candidate will have over 10 years of expertise in pharmacovigilance and will play a pivotal role in overseeing and managing the safety reporting process for pharmaceutical products. This role is a leadership position and requires a deep understanding of regulatory requirements, clinical safety processes, and the ability to lead and mentor a team.

Key Responsibilities:

Manage the end-to-end pharmacovigilance process, including the collection, evaluation, and reporting of adverse events (AEs) and other safety information.
Ensure compliance with regulatory requirements (FDA, EMA, ICH, etc.) and industry best practices.
Oversee the preparation and submission of Periodic Safety Update Reports (PSUR), Risk Management Plans (RMP), and other safety documents.
Lead and mentor a team of pharmacovigilance professionals, providing guidance and support in daily operations and long-term career development.
Work closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, and Medical Affairs, to ensure seamless safety monitoring across all stages of the product lifecycle.
Conduct signal detection, benefit-risk assessments, and risk mitigation strategies for marketed and clinical development products.
Act as the primary point of contact for all safety-related communications with health authorities, vendors, and internal stakeholders.
Participate in audits, inspections, and inspections with regulatory agencies as needed.
Keep up to date with the latest pharmacovigilance regulations, trends, and industry standards to ensure the company’s compliance and improve operational efficiency.

Key Qualifications:

Minimum of 10 years of experience in pharmacovigilance within the pharmaceutical, biotechnology, or clinical research industry.
In-depth knowledge of pharmacovigilance regulations (FDA, EMA, ICH, etc.) and industry guidelines.
Proven experience in managing teams and collaborating with cross-functional departments.
Strong leadership skills with the ability to motivate and develop a team.
Excellent written and verbal communication skills.
Strong organizational and problem-solving abilities.
Ability to work under pressure, meet deadlines, and adapt to changing priorities.
Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field. Relevant certifications in pharmacovigilance are a plus (e.g., PV certification from DIA, ISPE, etc.).

Preferred Skills:

Experience working with safety databases (e.g., ARGUS, Veeva Vault Safety, or similar platforms).
Prior experience in regulatory submission and compliance management.
Knowledge of data analytics and signal detection techniques.

Why Clinchoice:
Clinchoice is a global provider of clinical development solutions that help biopharmaceutical companies bring their products to market safely and effectively. At Clinchoice, we value our employees' contributions and offer a collaborative, growth-oriented work environment. Join us in making a difference in healthcare and patient safety!

Interested candidates can apply by sending their resumes to megha.chinnappa@clinchoice.com

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