Head - Medical Affairs (GM Level)

Liontree Hr Consultants; Mumbai; Hybride; INR 4 000 000 - 8 000 000; Plein temps

Résumé du poste

Exeltis India seeks a Head of Medical Affairs & Pharmacovigilance to provide strategic medical leadership for the India affiliate. You will ensure scientific excellence, governance, and a compliant PV system across the portfolio, acting as Medical Authority and PV System Head as required under applicable rules.

You will lead medical strategy, oversee pharmacovigilance activities, and drive regulatory reporting, audits, and complaint handling.

Qualifications

• MBBS mandatory; MD (Pharmacology / Internal Medicine / Community Medicine) strongly preferred.
• Additional qualifications in Pharmacovigilance, Clinical Research or Public Health is an advantage.
• 1518 years of pharmaceutical industry experience, with at least 46 years in a leadership role heading Medical Affairs and/or Pharmacovigilance.
• Demonstrated experience as PV Officer / Safety Physician with CDSCO, PvPI, EMA/FDA reporting frameworks.
• Proven track record of managing regulatory/PV inspections and audits.
• Experience across relevant therapy areas (e.g., women's health, dermatology, CNS, cardiometabolic, oncology, biosimilars as per portfolio).

Responsabilités

• Define and execute the India medical affairs strategy.
• Lead the medical plan for key therapy areas: evidence generation, publication planning, advisory boards, KOL engagement and scientific platforms.
• Provide medical input into product selection, in-licensing, due diligence, lifecycle management and new product introductions.
• Build and maintain KOL/HCP networks and represent the company in scientific forums.
• Oversee Medical Information services: response to unsolicited queries, standard documents, and medical enquiry databases.
• Serve as the final medical signatory for promotional and non-promotional materials.
• Ensure content compliance with UCPMP 2024, D&C Act, DMR (OA) Act and SOPs.
• Train and certify field force on disease, product and competitor science; support CME/CHE programmes.
• Own the local PV system, PSMF (India annex) and PV SOPs; align with Global QPPV/database.
• Ensure timely ICSR collection, processing, medical assessment, follow-up and regulatory reporting (CDSCO/NCC-PvPI).
• Oversee PSUR/PBRER, PADER-equivalents, signal detection, RMPs and safety label updates for India.
• Manage literature screening, SDEAs with partners, distributors and licensors.
• Lead PV audits and CDSCO/regulatory inspections; drive CAPAs to closure.
• Review protocols, ICFs, CSRs and publications; ensure ICH-GCP, Schedule Y and Ethics Committee compliance.
• Partner with Regulatory Affairs on dossiers, responses to queries, benefit-risk assessments and product labeling.

Connaissances

Medical & therapeutic expertise

PV regulations (India & global)

Benefitrisk & signal evaluation

Scientific communication & pubs

Promotional-material review & UCPMP

Clinical trial design & GCP

Formation

MBBS

MD (Pharmacology/Internal Medicine/Community Medicine)

Pharmacovigilance/Clinical Research/Public Health qualifications

Outils

Argus/ArisG safety databases

MedDRA

WHO-DD coding

Description du poste

Position Information

Position: Head: Medical Affairs & Pharmacovigilance (Medical Head, India)
Job Title: Medical Head Medical Affairs & Pharmacovigilance
Function: Medical & Scientific Affairs / Drug Safety Location: India (Corporate Office Mumbai / Delhi NCR / Hyderabad, as applicable)
Reports To: Director Strategy, Portfolio, BD, Medical Affairs, Regulatory, PV and ComEx - Exeltis India
Direct Reports: Medical Advisors, Medical Science Liaisons (MSLs), PV Associate
Travel: 2535% (domestic and occasional international)

Job Purpose

To provide strategic and operational medical leadership for the India affiliate ensuring scientific excellence across the product portfolio, robust medical governance, compliant promotional and non-promotional activities, and a fully functional pharmacovigilance (PV) system that meets CDSCO, PvPI and global corporate requirements.
The role acts as the Medical Authority for the country and serves as the local Pharmacovigilance Officer / PV System Head (or oversees the nominated officer) as required under the New Drugs & Clinical Trials Rules, 2019.

Key Responsibilities

A. Medical Strategy & Affairs

• Define and execute the India medical affairs strategy, aligned with global brand and portfolio strategies.
• Lead the medical plan for key therapy areas: evidence generation, publication planning, advisory boards, KOL engagement and scientific platforms.
• Provide medical and scientific input into product selection, in-licensing, due diligence, lifecycle management and new product introductions.
• Build and maintain KOL / HCP networks and professional society relationships; represent the company in scientific forums.
• Oversee Medical Information services: response to unsolicited HCP/patient queries, standard response documents, and medical enquiry databases.

B. Medico-Marketing & Promotional Governance

• Serve as the final medical signatory for promotional and non-promotional materials (visual aids, LBLs, digital assets, scientific decks).
• Ensure all content is scientifically accurate, balanced and compliant with UCPMP 2024, D&C Act, DMR (OA) Act and internal SOPs.
• Train and certify the field force on disease, product and competitor science; support cycle meetings and CME/CHE programmes.

C. Pharmacovigilance & Drug Safety

• Own the local PV system, PSMF (India annex) and PV SOPs; ensure alignment with the Global QPPV /global safety database.
• Ensure timely ICSR collection, processing, medical assessment, follow-up and regulatory reporting to CDSCO / NCC-PvPI within statutory timelines (15/30 days as applicable).
• Oversee PSUR/PBRER, PADER-equivalent submissions, signal detection, risk management plans (RMPs) and safety label updates for India.
• Manage literature screening, safety data exchange agreements (SDEAs) with partners, distributors and licensors.
• Lead PV audits and CDSCO / regulatory inspections; drive CAPAs to closure.
• Review protocols, ICFs, CSRs and publications; ensure ICH-GCP, Schedule Y and Ethics Committee compliance.
• Partner with Regulatory Affairs on dossiers, responses to queries, benefit-risk assessments and product labelling (PI/SmPC/PIL).

E. Compliance, Quality & Leadership

• Embed a culture of medical ethics, integrity and patient safety; work closely with Compliance, Legal and QA.
• Manage the medical & PV budget, vendors and CRO/PV service providers.
• Build, mentor and retain a high-performing medical and drug-safety team; define KPIs and development plans.
• Act as medical spokesperson in crisis / product safety issues, recalls and media/regulatory communications.

Qualifications & Experience

Essential

• MBBS mandatory; MD (Pharmacology / Internal Medicine / Community Medicine) strongly preferred.
• Additional qualifications in Pharmacovigilance, Clinical Research or Public Health is an advantage.
• 1518 years of pharmaceutical industry experience, with at least 46 years in a leadership role heading Medical Affairs and/or Pharmacovigilance.
• Demonstrated experience as PV Officer / Safety Physician with CDSCO, PvPI, EMA/FDA reporting frameworks.
• Proven track record of managing regulatory/PV inspections and audits.
• Experience across relevant therapy areas (e.g., women's health, dermatology, CNS, cardiometabolic, oncology, biosimilars as per portfolio).

Desirable

• Exposure to biosimilars, complex generics or branded generics in emerging markets.
• Experience working in a matrix, multinational organization with global/regional reporting lines.
• Familiarity with safety databases (Argus, ArisG), MedDRA and WHO-DD coding.

Competencies

Technical

• Medical & therapeutic expertise
• PV regulations (India & global)
• Benefitrisk & signal evaluation
• Scientific communication & publications
• Promotional-material review & UCPMP
• Clinical trial design & GCP

Behavioural

• Strategic thinking & business acumen
• Leadership and team development
• Influencing and stakeholder management
• Decision-making under ambiguity
• Integrity, ethics and compliance mindset
• Cross-functional collaboration

Key Interfaces

Internal: Marketing & Sales, Regulatory Affairs, QA/QC, Business Development, Legal & Compliance, Supply Chain, Global Medical Affairs & Global PV. External: CDSCO / IPC-PvPI, Ethics Committees, KOLs & medical societies, CROs & PV vendors, licensors/partners, academic institutions.

Key Performance Indicators

• 100% on-time regulatory safety reporting compliance (ICSRs, PSURs).
• Zero critical findings in PV audits/inspections; timely CAPA closure.
• Medical review turnaround time and promotional compliance rate.
• Execution of medical plan: advisory boards, publications, RWE studies, KOL engagement index.
• Field-force scientific training completion and knowledge scores.
• Team engagement and retention.