Pharmacovigilance Science Expert

The Pharmacovigilance (PV) Science Expert is a global role, and it supports an international, dynamic, and culturally diverse team dedicated to safety surveillance throughout the product lifecycle of a broad range of products.

The PV Science Expert is a safety expert who is responsible for performing core pharmacovigilance activities on a product, in partnership with the Global Safety Lead/Managers (GSLs/GSMs), to identify safety signals, evaluate, and analyze safety data for both marketed products and products in post marketing and clinical development.

Accountabilities:

-Manages ongoing core signal detection activities for Global Safety Leads/Managers (GSLs/GSMs) review (involve synthesis of data from multiple sources: PV database, literature, PV textbooks and external DBs)

-Coordinates and authors draft health hazard evaluations (HHEs) and/or safety evaluation reports (SERs)

-Primarily manages entry and tracking of signals, ME, INR in SMART tool and support GSLs/GSMs with any SMART related activities.

-Reviews periodic signal detection reports (NINR, UDR, SD reports for PBRERs)

-Contributes to responses to Health Authority questions or inquiries from internal or external stakeholders in collaboration with the Safety Team; includes proposing a strategy for the response review of relevant data.

-Is a Core member of the Safety Management Committee (SMC) who contributes to produce the necessary data outputs, prepares slide presentations.

-Supports GSL/GSM to provide safety content for new drug applications and other regulatory filings including review of the safety and benefit risk sections to ensure consistency across documents and support response preparation

-Supports GSL/GSM in drafting of the safety sections of the EU Risk Management Plan (RMPs) for Safety Team for review and comment.

-Contributes to risk assessment and benefit risk assessment for marketed products (Scheduling and coordinating meetings/ Drafting meeting agenda and minutes/Tracking action items and soliciting follow-up for open issues).

-Collaboration with various stakeholders including but not limited to PV Quality, Medical Safety, QPPV and PV Operations, Medical affairs, Labeling, Regulatory affairs and PV vendors.

-Provide OTC SWITCH SER Support.

-Supports in mentoring of new PV safety scientists (PVSs).

-Supports in audit and inspection preparation.

-Helping in management of process related queries at user level.

-Acting in the capacity of lead, which may entail serving as the primary point of contact, negotiating deliverable timelines, and resolving project related issues.

Experience

Working knowledge of drug safety and risk management including 5-8 years industry experience, and understanding of drug development, basic knowledge of regulatory guidelines and medical coding.

Soft skills

Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams

Technical skills

Evaluation, interpretation, and synthetization of scientific data

Knowledge of pharmacovigilance practices including US and EU pharmacovigilance regulatory requirements appreciated

Signal Risk Management: Expertise in the collection of drug safety information from a variety of sources throughout the product life cycle to proactively detect, validate, and assess potential signals appreciated

Proficient in international regulations, guidelines good practices pertaining to the pharmaceutical industry standard and practices in pharmacovigilance

Works well in a team setting as well as independently.

High attention to detail with exceptional writing, logical and problem-solving abilities.

Eagerness to learn.

Excellent individual veracity, with a solid personal commitment to follow all guidelines, protocols, Standard Operating Procedures and the companys values and ethics, as well as comply with pharma Codes and regulations.

Ability to collaborate between different teams and functions.

Excellent networking and influencing skills

Education

Preferred health care discipline degree in modern science: Masters in Pharmacy, Master of Health Science, Physician Assistant, MBBS, BDS etc

Languages