Pv Specialist-Safety Data Exchange Agreements (Sdea)

2+ years

Not Disclosed

Hyderabad

10 Dec. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: PV Specialist

Location: Hyderabad, India

Company Overview:

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company with a global presence in over 66 countries. With over 24,000 employees, our mission is to accelerate access to affordable and innovative medicines because Good Health Can’t Wait. Established in 1984, Dr. Reddy's is driven by a commitment to access, affordability, and innovation, supported by strong governance practices.

We are purpose-driven, future-ready, and focused on sustainability, aiming to reach over 1.5 billion patients globally by 2030. We operate with integrity and transparency while continuously improving to meet business needs and drive positive change in healthcare.

Job Summary:

The PV Specialist is responsible for overseeing and managing SDEAs (Safety Data Exchange Agreements) and PVAs (Pharmacovigilance Agreements) across various business relationships globally. This role includes coordinating with stakeholders, ensuring agreements meet regulatory requirements, updating and drafting agreements, and leading negotiations with business partners.

Main Responsibilities:

Agreement Management:
- Coordinate with stakeholders across regions to assess, draft, review, and ensure compliance with SDEAs/PVAs.
- Ensure all agreements are aligned with regulatory requirements and internal standard processes.
- Lead the negotiation process with business partners for PVAs, ensuring all necessary pharmacovigilance obligations are included.
- Maintain a global comprehensive tracker for executed PVAs and their related agreements.
Periodic Review & Updates:
- Manage the periodic revision of PVAs to ensure they align with current regulatory requirements and standard procedures.
- Review and update PVA templates to ensure they remain in line with evolving legislation and functional processes.
Compliance & Monitoring:
- Ensure compliance with the terms and conditions of PVAs and provide regular updates on compliance status.
- Escalate major non-compliance issues during internal compliance meetings.
- Monitor and ensure post-signing implementation of PVAs.
Due Diligence & Audits:
- Support pharmacovigilance due diligence activities for new product acquisitions and divestments.
- Act as a subject matter expert during audits and regulatory authority inspections.
Process Improvement & Automation:
- Identify opportunities for process improvement and propose recommendations.
- Support the automation of the PVA management process, including the establishment of reporting rules for ICSRs (Individual Case Safety Reports) distribution.

Qualifications:

Education: A degree in a related field (Pharmacy, Life Sciences, etc.)
Experience: Previous experience in PVA management or pharmacovigilance operations. Understanding of global regulatory requirements, including FDA, EU, and emerging market guidelines.
Skills:
- Strong understanding of commercial agreements and PV strategies.
- Excellent teamwork, interpersonal, and organizational skills.
- Proficient in time management and managing multiple projects.

Desired Competencies:

In-depth understanding of pharmacovigilance operations.
Ability to manage negotiations and maintain strong relationships with key stakeholders.
Knowledge of regulatory obligations and ensuring alignment with business terms.

Benefits Offered:

Career Development: Personalized learning and development programs.
Health & Wellness: Comprehensive medical and life coverage for you and your family.
Work-Life Balance: Family support, including maternity/paternity benefits.
Relocation Support: For applicable positions.
Learning & Growth: Opportunities for professional advancement and skill development.

About the Department:

The Global Manufacturing Organisation (GMO) at Dr. Reddy’s plays a critical role in impacting global healthcare through precision manufacturing and innovation. With state-of-the-art facilities across multiple locations, we are dedicated to delivering quality medicines globally. We manufacture complex APIs and a wide range of pharmaceutical products in key therapy areas, including Oncology, Cardiovascular, CNS, and Anti-Diabetes.

Dr. Reddy’s Laboratories is committed to fostering a culture of inclusivity and equality, ensuring all employees are valued and recognized for their unique skills. If you're passionate about making a difference in global healthcare, apply today!

For more information, visit our career page: Dr. Reddy’s Careers

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Pv Specialist-Safety Data Exchange Agreements (Sdea)

Job Description

Job Title: PV Specialist

Company Overview:

Job Summary:

Main Responsibilities:

Qualifications:

Desired Competencies:

Benefits Offered:

About the Department:

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