Data Protection Manager (Mumbai)

Data Protection Manager (Mumbai)

12 Sep
|
Navlakha Management Services
|
Mumbai

12 Sep

Navlakha Management Services

Mumbai

- Role Overview
- The Manager Data Protection will lead the organizations data privacy and governance framework within a regulated pharmaceutical workplace. This role ensures compliance with the Digital Personal Data Protection Act, 2023 and other global privacy regulations, while addressing the unique challenges associated with clinical, patient, and research data.

- The role requires a strong blend of legal, regulatory, and technical expertise to operationalize privacy requirements across R&D;, clinical trials, pharmacovigilance, manufacturing, and commercial functions.

- Key Responsibilities
- 1.

Regulatory

Compliance &
- Policy Framework

- Ensure compliance with the Digital Personal Data Protection Act, 2023 and applicable global regulations (e.g., GDPR, where relevant). Develop, implement, and maintain data protection policies, SOPs, and governance frameworks tailored to pharmaceutical operations.Ensure lawful processing of sensitive personal data, including patient health information and clinical trial data. Monitor regulatory updates impacting pharma data practices and drive timely compliance.

- 2. Clinical &

- Patient Data Governance

- Oversee data protection practices for clinical trials, patient support programs, and real-world evidence data. Ensure compliance with informed consent, ethical standards, and data anonymization/pseudonymization requirements. Collaborate with clinical research and pharmacovigilance teams to safeguard adverse event and patient safety data.

- 3. Data Mapping, Risk Assessment &

- Mitigation

- Conduct enterprise-wide data mapping, including R&D; systems, clinical databases, ERP, and CRM platforms.

- Identify and assess privacy risks, especially for sensitive health and genetic data.
- Implement mitigation strategies aligned with regulatory and industry best practices.

- 4. Third-Party &

- Vendor Risk Management

- Manage privacy compliance of CROs (Contract Research Organizations), CMOs, distributors, and other third-party partners. Act as the primary coordinator for external DPDP gap assessments and audits.



Ensure vendor contracts include appropriate data protection clauses and safeguards.

- 5. Privacy by Design &

- Project Reviews

- Embed privacy-by-design principles into digital health platforms, clinical systems, and business applications.

Conduct Data Protection Impact

Assessments (DPIAs) for high-risk processing activities. Review new initiatives (e.g., digital therapeutics, patient apps, AI/analytics projects) for privacy compliance.

- 6.

Incident

Management &

- Regulatory Reporting

- Lead response to data breaches involving patient, clinical, or employee data. Assess impact and determine regulatory reporting obligations under applicable laws. Coordinate with Legal, IT Security, and Compliance teams for incident resolution and reporting.

- 7. Cross-Border Data Transfers

- Oversee international data transfers related to global clinical trials and research collaborations. Ensure compliance with cross-border data transfer requirements and safeguards. Align with global affiliates and headquarters on data protection standards. 8.

Grievance

Redressal &

- Data Subject Rights Act as the Nodal Officer for handling data principal (patient, employee, HCP) grievances. Ensure timely resolution of requests related to access, correction, withdrawal of consent, and erasure.

- Education &

- Certifications

- Bachelors degree in IT Law, Privacy Law, Cybersecurity, Life Sciences, or related field.

Preferred certifications: CIPP, CIPM, DPO certification, or equivalent.

- Experience -

- 57 years of experience in data privacy, preferably within the pharmaceutical, healthcare, or life sciences industry.

Experience handling clinical trial data, patient data, or regulatory compliance frameworks is highly desirable.

Key Competencies

Strong understanding of pharma regulatory environment and data privacy laws .

- Expertise in handling sensitive health and clinical data Risk assessment and mitigation capabilities Excellent cross-functional stakeholder management (R&D;, Clinical, QA, IT, Legal) .High ethical standards and confidentiality awareness .Ability to translate regulatory requirements into operational processes

📌 Data Protection Manager (Mumbai)
🏢 Navlakha Management Services
📍 Mumbai

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