Pharmacovigilance Manager chez Galderma

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

• 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.