Pharmacovigilance Manager

Galderma

6 - 11 years

8 - 13 Lacs

mumbai

Posted:1 week ago| Platform:

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Skills Required

project management pharma market research healthcare life sciences pharmacovigilance continuous improvement risk management monitoring auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Function Duties and Responsibilities

Implements and maintains the local vigilance system and its quality system, including management of local Standard Operating Procedures (SOPs) and related indicators, audits and inspection readiness, and record management of relevant documentation.
Manages safety information received from any sources including their receipt, follow-up, reconciliation, documentation, and submission to local authorities in accordance with local and global SOPs, third-party agreements and regulatory requirements.
Conducts screening of local literature and ensures adequate monitoring of digital media and social networks to identify safety reports involving Galderma products.
Contributes to the preparation and submission of aggregate safety reports to local authorities.
Contributes to the management of safety signals and escalates any trends that may impact the benefit-risk profile of a Galderma product.
Contributes to the management of safety risks and implements local Risk Management Plans (RMPs) where required.
Contributes to the conduct and oversight of post-marketing studies sponsored and managed by Galderma India, i.e., non-interventional studies, interventional studies, post-authorization safety studies, investigator-initiated trials, patient support programs, drug utilization studies, market research, etc.
Implements and maintains Safety Data Exchange Agreements (SDEAs) with local Vigilance Agreement Partners (VAPs).
Establishes and delivers vigilance training to affiliate and local VAP employees, and maintenance of training records.
Organizes the regulatory intelligence and business continuity of vigilance activities.
Establishes and maintains relationships with interacting departments and organizations, i.e., local authorities, local VAPs, affiliate Business Units, etc.
Contributes to the continuous oversight of the European Union (EU) Qualified Person Responsible for Pharmacovigilance (QPPV) by updating the dedicated tool with the required vigilance Key Performance Indicators (KPIs) relating to the local vigilance system.
Notifies the JPAC Head of PV and Global PV Compliance of any announcement of inspection by the local authorities or audit by a local VAP; leads local vigilance inspection and audits activities; and is responsible for the development, implementation, follow-up, and resolution of Corrective and Preventive Action (CAPA) plans.
Participates in Global PV and JPAC PV meetings.
Supports any ad-hoc duties as assigned from time to time.
Function

Duties and

Responsibilities

Others
Foster and maintain good cross-functional working relationships with other departments.
Represent Galderma India in the relevant committees of the professional/industry associations, if necessary.
Profile

Requirements

Education and Training

Master s degree in pharmacy, Life Sciences or equivalent related field, a licensed Pharmacist is preferred.

Work Experience
Minimum 6 years of pharmacovigilance, medical device vigilance and/or cosmetovigilance operations experience in the pharmaceutical, biotechnology or consumer healthcare industry with demonstrated knowledge of local and global vigilance regulations, submission requirements and management of local and global authority requests.
Language

Proficiency in written and spoken business-level English.

Required pre-requisites skills/experience for this position
Good analytical skills and attention to detail with the capability to appropriately define issues, questions and data.
Good project management, problem-solving, time management, negotiation and interpersonal skills.
Self-starter with the ability to work both independently or as part of a team as required.
Commitment to continuous improvement in functional processes and performance.
Good team player, assisting others with workload peaks and management of challenging situations.
Proactively contributes to a positive team attitude and highly productive work environment.

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