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

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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 current 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
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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
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Own the local PV system, PSMF (India annex) and PV SOPs; ensure alignment with the Global QPPV /
global safety database.
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Ensure timely ICSR collection, processing, medical assessment, follow-up and regulatory reporting

to CDSCO / NCC-PvPI within statutory timelines (15/30 days as applicable).
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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.
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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, benefitrisk assessments and
product labelling (PI/SmPC/PIL).
E. Compliance, Quality & Leadership
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Embed a culture of medical ethics, integrity and patient safety; work closely with Compliance, Legal
and QA.
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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.
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Act as medical spokesperson in crisis / product safety issues, recalls and media/regulatory
communications.
QUALIFICATIONS & EXPERIENCE
Essential
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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.
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Demonstrated experience as PV Officer / Safety Physician with CDSCO, PvPI, EMA/FDA reporting
frameworks.
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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
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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:
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Medical & therapeutic expertise
PV regulations (India & global)
Benefitrisk & signal evaluation
Scientific communication & publications
Promotional-material review & UCPMP
Clinical trial design & GCP
Behavioural:
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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
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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.

📌 Head - Medical Affairs (GM Level) (Mumbai)
🏢 Liontree HR Consultants
📍 Mumbai