Highlights:Pharmacovigilance Operations Manager with total 9 year of experience. That includes 8+ year of experience in pharmacovigilance activities, with four year of experience in managerial roles. Experience in setting up several newly awarded and legacy client accounts/projects for Post Marketing setup. This essentially includes but is not limited to setting up safety databases, ICSRs, aggregates, literature and signal detection activities and drafting their SOPs and controlled documents to assure compliance with regulatory timelines and guidelines of responsible safety regulatory authorities. Experience in setting-up and management of Medical Information Call Centers (MICC) for safety data collection, marketing, Patient assistance and medical information activities. Experience in contract management, billing/invoicing and related activities. Additional one year of experience as QA officer in WHO approved pharmaceutical manufacturing unit.

Skills:Pharmacovigilance, drug safety, post marketing, signal detection, icsr, literature

Goal:To be a well known Drug safety and pharmacovigilance professional in the industry. Get in to core PV industry at highest level utilizing my skills

Membership:N/A

Certification:Manager Pharmacovigilance with 9 years of experience

Manager Pharmacovigilance Operations Dec/2021 - current
Clario, Mysore, Karnataka India
Industry: Contract Research Organization
Responsible for maintaining quality and regulatory submission/ Partner submission compliance of a team of approx. 1000 individuals
Manager for quality & compliance and is responsible to ensure SLA/contractual and regulatory compliance. Management of CAPA and implementation of preventative and corrective plans. Direct dealing with client and other vendors on quality and health of the PV system--
Manager Pharmacovigilance Operations May/2014 - Dec/2021
Parexel International, Chandigarh, Punjab India
Industry: CRO
Management of project along with contract and SLA implementation and project deliverables. First line of contact with vendors and clients.
• Supervision and management of Safety services staff and external consultant personnel (as applicable) • Management of project budgets and resourcing, serving as internal and external representative for safety services. • Seeking and following up on safety services sales opportunities for the current and prospective clients; and leading departmental and cross-functional communications, training, and process improvements. • Support safety services management during the sales process by leading bid defence meetings, client interactions, proposals input, and contract review. • Spearheading clients’ and executive level meetings to discuss KPIs & SLAs to discuss and plan future deliverables and challenges. • Act as an SME for Signal detection, Batch trend analysis, ICSR processing related activities. Including preparation of SRR (Safety review report), SRS (Safety review sheet) and final reports for clients. • Good experience in drafting global literature search strategies to be used for medline.com, Embase.com search engines and including its sensitivity testing. Along with setting up local literature searches for client. • Good knowledge and experience in preparation of client specific procedural documents like SOPs, Work Instructions, Manuals, etc. • Management of monthly invoices and contracts, Work orders (WO), Scope of work (SOWs) and change in scope (CIS) as and when required, keeping profitability in mind. • Development and execution of new KPIs and SLAs. • Experience in ICSR submissions to FDA via automated submission gateways like Axway, to submissions through Endpoint Security Manager (ESM) Server and manual transmission/submissions through webtrader.--

Shoolini University Aug 2006 - Aug 2012
Solan, Himachal Pradesh, India
Degree: Master's Degree
Major:Master of Pharmacy
Minor:Bachelor of Pharmacy
Master of Pharmacy

Ankur Sharma Pharmacovigilance