Serm Assoc Medical Director

7+ years

Not Disclosed

Bangalore

10 Dec. 19, 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 and Risk Management Expert
Location: Bengaluru Luxor North Tower, Bengaluru
Posted Date: Dec 17, 2024
Experience: 10-15 years

Job Purpose:
This role provides critical medical and scientific expertise in the safety evaluation and risk management of key GSK assets during clinical development and in the post-marketing phase. The incumbent will ensure scientifically sound reviews of data, manage safety issues, and escalate concerns to senior management when needed. The role emphasizes risk management strategies, efficiency, and the communication of safety risks to ensure global patient safety. The position may involve leading a team and driving improvements in pharmacovigilance practices.

Key Responsibilities:

Scientific/Medical Knowledge & PV Expertise

Oversee signal detection and evaluation for assigned products.
Lead the creation of regulatory periodic reports and Risk Management Plans (RMPs) according to global standards, ensuring timely delivery.
Collaborate with the product physician to contribute safety data for global regulatory submissions.
Respond to audit and inspector requests, ensuring corrective and preventive actions (CAPAs) are completed on time.
Demonstrate advanced evaluation and analytical skills for literature reviews, data gathering, and synthesis.
Make informed decisions based on data analysis, identifying, evaluating, and recommending solutions to safety issues.

Cross-functional Matrix Leadership

Support and facilitate safety governance and cross-functional teams (e.g., Safety Review Teams - SRTs) to address product safety issues and implement risk-reduction strategies.
Lead process improvement initiatives and workstreams to enhance compliance, quality, and efficiency in safety management.
Mentor team members, offering coaching and guidance on safety-related matters.
Contribute to the creation and revision of internal standards, policies, and SOPs to ensure consistent regulatory adherence.

Communications & Influencing Skills

Present complex safety issues to senior management and governance committees.
Contribute creatively to operational improvements and process advancement within the organization.
Effectively communicate findings and strategies across teams, utilizing both written and verbal skills.
Persuade and negotiate effectively to align teams with safety perspectives and strategies.

Education and Experience Requirements:

Medical Doctor (Physician) preferred, or equivalent (e.g., veterinarian/dentist) with relevant pharmacovigilance experience.
Substantial experience in pharmacovigilance, including both clinical development and post-marketing safety evaluation and risk management.
Strong knowledge of international pharmacovigilance regulations (e.g., ICH, GVP, CIOMS) and drug development processes.
Proven ability to lead teams and manage cross-functional, matrix organizations.

Why GSK?
At GSK, we unite science, technology, and talent to tackle disease. Our global biopharma company is focused on delivering impactful healthcare solutions, ensuring a strong future for our people and patients alike. By fostering a collaborative and inclusive environment, we empower individuals to thrive. Join us in our journey to improve health and deliver transformative results.

Important Notice:
GSK does not accept job referrals from employment agencies without prior written authorization. GSK never charges fees for recruitment processes. Please report any fraudulent activities related to GSK job postings.

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Serm Assoc Medical Director

Job Description

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